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iDataFax User Guide - CLARITY Randomization Website

1. Fax Name d Vist ot Queries 0924 0004001 1004 o Reasons SETA g Reports Status Pationt List Initials FM l BLOOD PRESSURE SCREENING VISITS Sex Male Race Caucasian Fomale gt African Americar lic diastolic Screon 1 Date 21 01 09 Reading 1 160 A l Reading 2 160 100 Reading 3 160 104 i ss ee Ree Ieee OetaFax 263 Pisto 001 Visit 000 Next Set Previous Set Taras ee OTT OLOIS sa Query BLOOD PRESSURE SCREENING VISITS Race C Caucasian m Afican Amarican Reason for Data Value Screen Save v 0 gt 1 Missing Value First 2 boxes center number Fax View illustrated above can be used to enter new data records from paper case report forms CRFs that have been faxed or emailed to the DataFax study server or to enter new data records from hardcopy CRF pages you have in hand and do not plan to fax into the system When a DataFax server receives a faxed CRF page it reads the bar code to identify the study and CRF plate routes the page to the study and then uses ICR intelligent character recognition to read the data fields and complete a first draft of a new data record These records are stored outside the study database They must be reviewed and saved to the study database to become available to users in Data View 78 7 1 The Record Selection Dialog DataFax ICR reads check boxes numbers dates and visual analog scales but accuracy depends on how clearly each field
2. 94 8 7 Saving Defined Views year n Use year to test for a year in a date e g to find records modified in 2008 year DFMODIFY 2008 If the expression builder does not have the capabilities you require searching can also be performed using a custom program specified in the last option at the bottom of the Search dialog Custom programs must be stored in the study ecbin directory and must generate a DataFax retrieval file as output DataFax includes 2 standard programs DFmkdrf ec and DFmkdrf jnl described in the Appendix which can also be used for this purpose When searching By Program the Filter option must be enabled When the Filter button is selected the record list will be reduced to show only those records identified by the program If in addition to the By Program option the Expression builder or any of the other options in the Data Records section are used records will only be selected it they meet all of criteria specified by all of these options If any of the Data Fields options are used the set of records selected will be further reduced to include only those records that meet at least one of the field level criteria 8 7 Saving Defined Views List Views consisting of specified data fields field order and record selection criteria can be defined for use by specified users and or roles using Select Define Views to bring up the dialog illustrated below The steps include the foll
3. 3 10 How should respond to a query if the data field is correct as is If a query asks you to correct a data value that is already correct respond using one or more of the 3 metadata windows e If the field is blank and an appropriate missing value code is available select it using the button on the Missing Value metadata window If the field is defined as essential this will not be possible e To explain why the value is correct as is add a reason by clicking the button in the Reason for Data Value metadata window e To reply to the query directly click the button in the Query metadata window When you respond in one of these ways the data field will change from blue to green if the response resolves the problem or orange if the response needs to be reviewed by the study coordinating center 3 11 Can I indicate that a patient assessment is unavailable Yes A patient assessment might be unavailable for a variety of reasons The patient might have missed a Clinic visit or refused a particular lab test In such cases you can indicate that the assessment is lost Assessment Mark Assessment Lost To mark an assessment lost ana DataFax Mark Assessment Lost 1 Select View gt Data to open the data view Site 1 Patient 1002 Assessment 4 Month Follow up 2 Double click the patient binder to open it and Why Patient missed visit ot display the study assessments Details The patient was away on vactaion for 2 m
4. Update the date and or time on the computer that is running iDataFax Field field_name storing value field_value which contains illegal extra characters into variable has altered the value The field value stored in the study database is different from the value displayed in the field widget on screen The database value may not match the field format or may be larger than the current field store length The study setup specifi cations may have been changed to make previ ously entered values incompatible with the current field specifications Reenter the specified fields with values compati ble with the current field properties and save the record to the study database This section describes the standard DataFax programs available for both adhoc record selection and task definition 13 3 1 DFmkdrf jnl make DataFax DRF file from study jour nals 133 iDataFax User Guide Program DFmkdrf jnl processes the study journal audit trail files and can be used to identify records entered by specified users during specified times with specified criteria Its output includes all records that match the specified criteria but any given user will only see those records they have permission to get The program usage message follows 134 13 3 1 DFmkadrf jnl make DataFax DRF file from study journals DFmkdrf jnl make or load a DataFax Retrieval File USAGE DFmkdrf jnl DFNUM t datel date2 days
5. u include_users xu exclude_users v levels s statuses I IDs S SEQs P plates image yes no d 1 2 records cases put drfname h header get drfname test OPTIONS DFNUM DataFax study number may be 1st argument or set in t yymmdd yymmdd selection period dates during which records were saved days select records saved in the past days u list of users select records saved by specified users xu list of users exclude records saved by specified users v select records saved at specified validation levels 0 7 s status select statuses final incomplete pending lost I select patient ID numbers S select sequence visit assessment numbers P select plate numbers image yes no select records with images only or without images only dl deselect if criteria no longer apply at end of selection period d 2 deselect if criteria no longer apply now journal s end records Maximum number of data records to be included in the drf file cases Maximum number of patients to be included in the drf file put drfname write output to a specified drf file in the study drf folder h header include a descriptive header title for the drf file get drfname load an existing drf file from the study drf folder test check and display record selection options then quit NOTES 1 DFNUM does not need to be specified when ru
6. Status Pending review Created dwt May 9 2006 11 19 24 AM Resolved Stroke Penphera l Vascular Disease Reason for Data Value Reason Patient has a congenital mitral Other specify valve defect surgically corrected at age 6 Status Approved Kneee surgery Created jack May 8 2006 1 04 23 AM Reviewed dwt May 9 2006 11 18 46 AM Save Incomplete Missing Value Last Save May 16 2006 4 55 53 PM Legal values are 0 80 The components of the Data view window shown above include the following e Patient Binders To enter or review patient data start by selecting a patient binder from the list displayed on the left side of the screen Each patient binder contains the data forms CRFs for an individual patient organized in subsections by study visit or assessment Each binder is represented by an icon resembling a human head followed by a patient ID number In the example above the binder is open for patient ID number 1002 You can open only one binder at a time This locks the patient records giving you exclusive access to the binder until you close it Patients assessments and CRF pages are color coded as follows Oo green no problems Oo red some data problems exist orange data entry was interupted and remains to be completed e The Data Window The data window is an exact replica of the study paper CRFs This is where you enter data values filling out the form using a keyboard and mouse instead of pen and pa
7. After you complete the first field use the Return or Tab key to move to the next field Continue in this way to complete all fields on the page This will ensure that you walk through all fields in the order planned by the form s designer Some fields may have edit checks that are triggered as you move in or out of them Moving through all fields will ensure that all of the edit checks are triggered and thus that you will be notified of any problems Some edit checks may also be triggered when you select Final Incomplete or Pending to save your changes But those edit checks which have been setup to trip on field entry or exit will only fire if you move through the data fields Read any warning or error messages displayed by edit checks carefully and take any necessary action to correct or explain any unexpected values You can move backward through the fields using Shift Tab and Shift Return When you have completed all of the fields on the page remember to save your work by clicking one of the 3 Save buttons at the bottom of the screen e Final if all fields have been completed and there are no red or blue problem fields e Incomplete if any field is still incomplete or there are unresolved queries or illegal values e Pending if any field is incomplete and you want to complete the page before it is reviewed by the study coordinating center a Note Pending can not be used after a page has reached Final or Incomplete st
8. Assessment Page Field Level Creation Modification SFF Resolution Pattern Deta gt Criteria have been specified eke WDatafax Query Detail Usage external internal Type _ clarification __ correction Status F new not in QC report Clin QC report not sent C in QC report sent l resolved not available _ resolved not rellevant _ resolved corrected L pending Probleme v missing wv ilegal A inconsistent FA itlegibie v fax noise __ missing page _ EC missing page _ overdue visit wv other Last Report Query Text Note Text Reply Text tore Gear Cancet gt 47 4 8 2 Defining Tasks This example illustrates a task for someone who reviews new queries created by data entry staff during new data ebtry at level 1 to make sure they are clear and appropriate before being sent to the clinical sites in a QC report This task should be performed using the Field Review Queries amp Reasons dialog so that queries can be saved on their own raising them to level 2 without changing the work flow level of the data records iDataFax User Guide Example 3 Search Reasons iDatafax Define Tasks l Task Reasons New Mode Modify EP Sign off Level 2 rs Vv Enable edit checks New reasons entered to explain data values are set to status Pending with the expectation that they will be reviewed and either approved or rejected along Search _ Data Queries Reasons By program w
9. check box can be used to prevent the key fields study plate and visit from being cleared when each new page is selected If a set of pages all have the same keys and do not require image processing they can be identified together in one step by making multiple selections from the page list before clicking the identify button The router sends all identified pages whether barcoded or not to the new record queue where they are processed in Fax View along with pages that were identified automatically from their bar codes The rest of this chapter describes the options available under each of the menus at the top of the screen 11 5 The File Menu 11 5 1 Update Records Select Update Records from the File menu to update the page list with any unidentified pages that may have arrived since the current session began 11 5 2 New Study Select New Study from the File menu to open the study selection dialog and select a study while keeping the router window active 11 5 3 Close Router Select Close Router from the File menu to close the router window and return to the iDataFax login dialog 11 5 4 Exit Select Exit from the File menu to exit the router and iDataFax 11 6 The Page Menu This menu contains a number of functions which allow you to manipulate pages rotate shift flip cut trun cate and reset to clean them up before sending them to the study database It also contains functions for turning to the next or prev
10. s study role Each imported data record may either create a new data record in the study database or replace an exist ing data record having the same keys ID visit plate If a replacement record is imported all of the data fields on that record are replaced it is not possible to replace only some fields while leaving others unchanged If a replacement record is imported with status 7 delete the database record will be deleted Import options may be set to add the reason Set by iDataFax Import to any field that is changed and to add automatic queries for missing and illegal values All imported data records plus any reasons and queries generated during import are logged in the study audit trail by date time and the user performing the import Step 1 Select the Input Data File File Import Data iDataFax Input Data File Select Datafax piate to import 001 Blood Pressure Screening Visits 04 Select field mapping file Select input data file Users jack tmp ScreeningData_150910 dat Data Preview Subject Initials Cender Age Ethnicity ScreenDate S8P1 D8P1 S8P2 D8P2 S8P3 D8P3 0 01001 LK 1 66 2 15 09 10 142 110 146 110 144 110 01002 KAH 1 62 1 15 09 10 38 98 140 100 142 100 s Field delimiter default comma Tab first row contains field names _ input date format per study setup Preview first 5 records Cancel Next Map data fields 1 First select the import destination i
11. status secondary and can be reviewed by selecting Page Review Images or clicking the image count button in Data View If one or more images have been linked to the current data record 2 buttons will appear in the lower right corner of the screen in Data View 2 Clicking the button labelled i will toggle the primary image between show and hide Depending on which option is currently set in User Preferences the screen will either split to show both the data and image windows or toggle between showing just the primary image and just the data screen 40 4 7 Images of CRFs and other Documents The i button is prefixed with another button that shows the number of images linked to the current data record Selecting this button or selecting Review Images from the Page menu brings up a dialog illus trated below which can be used to review and manage the images Page Review Images iDataFax Review Window image ID Received Status Sender ID Primary Left 1047 0004001 Thu Nov 25 20 42 09 2010 primary iDataFax Submit POF jack aor rmm 900 datatax con ___ secondary iDataFax Import POF jack _ Delete Reset a HAMILTON MEDICAL CLINI EEEI a i 3 Pil 25 Main St Leap NERED hA C Phone 905 522 3282 Fax 905 522 7284 Prens intiais Dr John Snow Date June 1 2009 AD To Demo study coordinator Pisase complete a sep ddi mmi yy Re Adverse event report 01 for patient 0 Onset Dat
12. 10 2 l 06 2 1 007 Study Termination a 02007 ake 008 Medication Change Log 6 02008 POP 08 06 10 2 1 1 009 Adverse Event 7 02009 QWE 11 09 10 2 2 3 010 Death Report x 011 Weekly Patient Diary 8 02011 JOK 19 08 10 2 13 05 33 177 0 B 077 069 2 2 042 Baseline Meds page 2 9 11002 BBB 15 01 11 2 14 03 85 070 0 185 B oo 1 1 M age 3 F e COST baseline Meds page 10 13002 asc 02 01 10 2 E 150 0 150 S o i 1 1 101 Missed Visit Report 102 Early Termination Report 1i 15001 JRF 02 01 11 168 066 0 056 1 E metadata QC Reports 1215002 JMP 05 12 10 2 04 10 70 147 8 175 0689 052 3 2 metadata Reasons metadata Queries 13 18003 RTW 01 03 11 2 02 01 64 155 5 068 5 055 2 1 metadata Lost 14 15004 TYR 02 02 11 2 03 03 55 160 0 063 0 051 4 1 a gt Switch to Data View Query TULL Visit 001 DataFax 253 Problem inconsistent reply required Details Initials TIF on this page differ Patlont oA olo Paticnt Fale onnonn from initials TIR from Visit O Plate 1 Number 012 og initials Entry Date n u n Status Outstanding FML dd mm yy Created dwt June 22 2011 16 44 10 PATIENT ENTRY FORM Resolved Eligibility Reason for Data Value Does the patient stii mast pi Yes the eligibility criera Cl ve Explain Save 1 view mode Missing Value Last Save June 22 2011 16 36 33 Use underscore for missing initials e g M_T 8 2 User Preferences The List View section
13. 2 2220 33 A d we en a e re ae 33 34 eens E So Ea R 35 4 4 Entering Data and Metadata 35 36 EES 36 40 4 8 Working with Tasks i 42 iDataFax User Guide 4 8 1 Performing Tasks 8 2 Defining Tasks 9 1 Changing Mode and Level ea 9 3 Select By Data Retrieval File 9 4 Select Batch Validate 4 10 Using Lookup Tables 11 Query Management F AA AA AA F ms 14 Transmitting Scanned CRFs 15 Importing Patient Documents 4 16 Data View Menus 16 1 File Menu 16 2 Edit Menu 16 3 Select Menu 16 4 Show Menu 16 6 Assessment Menu 16 7 Page Menu 5 2 Query Status 3 1 The Show Menu 3 2 The Query Menu 6 1 The Reasons Table 6 2 Reason Status 3 1 The Show Menu 3 2 The Reason Menu 7 1 The Record Selection Dialog 3 Entering Refaxed CRFs 4 Correcting the Ke 5 Switching to Data View 6 Record Locking in Fax View 7 7 1 The Select Menu 7 1 2 The Page Menu 8 1 Introduction 2 User Preferences 4 Working on a Task 6 Searching Data Records 8 8 Exporting Data Records 9 Exporting a Data Retrieval File 8 10 Exporting SAS Data Sets K E AAA AA AADA rez KSN re gt OD NI n SJNININ o o O o O0 n lo C0 0
14. 52 Select By Data Retrieval File r b m p iDataFax Select by Data Retrieval File Mode Edit Z Sign off Level 2 i KA Enable edit checks Select file from my computer study server Users Shared studies demo2 3 drf VDillegal drf Selected file VDillegal dri Description dwt 08 11 19 Illegal visit dates detected by DF_XXkeys OK Reset Cancel 4 9 4 Select Batch Validate The DRF in this example is named VDillegal drf This is a standard DataFax DRF which lists illegal visit dates detected by DataFax report DF_XXkeys Edit mode is specified which means that the work flow level of existing data and metadata records will not be changed The Sign off level of 2 will only be used for any new queries or reasons that are created during the review If the DRF contains a descriptive header it will be displayed in this dialog when the file is selected If each record in the DRF includes a description e g explaining why it was included it will be displayed in the message window at the bottom of iDataFax when a record is selected in the record list This is optional and may not be present in all cases 4 9 4 Select Batch Validate The Batch Validate feature is used to move all selected data records to a specified validation level in one step Users require permission for Data with Select to use this feature Data records can only be batch validated if they meet all of the following criteria e The
15. CREATED BY jack Dec 06 2007 08 44AM using OFsas 0 GLOBAL SPECIFICATIONS OFNUM 253 SASDIR Users Shared studies deno2 3 dfsas RUNDIR C1 studies demo253 sas jobs SASJOB test3 SASVERSION 7 PATIENTS 41 VISITS all OPTIONS YEARCUTOFF 13920 IMPUTE no INFORMAT dates FORMAT dates IDNAME ID CHECK codes CHOICE codes VLABEL yes VALFMT yes BLANK all asis RETAIN QUOTES no MISSING all asis MISSING lost MISSING SAS U D A R NOVISIT RECSTATUS clean dirty lost MERGE yes DATA RETRIEVALS RECORD 1 1 DFSTATUS DataFax Record Status 2 DFVALID DataFax Validation Level 3 DFRASTER DataFax Raster Name 4 DPSTUDY DataFax Study Number 5 DFPLATE DataFax Plate Number 6 DFSEQ DataFax Sequence Number 8 PINIT Patient Initials 9 AGE Age Add SE nt Delete Run Save Care iDataFax works with DFsas job files located in the study dfsas directory on the DataFax study server All existing DFsas job files are listed when the DFsas window is opened and the list is updated if any new jobs are added Selecting a job file loads it into the text window where it can be edited and saved back to the study server Selecting Run executes DFsas for the current job which creates SAS job and data files and returns them to the local PC in a zip file which is stored in the specified RUNDIR New DFsas job files can be created by selecting the Add button and using the dialog illustrated below The ne
16. Data Queries J Reasons Moby program They can consist of data query or reason 5 gt criteria or any standard DataFax or rogram OF mkdrf jnl xu whoarni v 1 image yes s4 final incomplete d 2 custom program that outputs a DataFax retrieval file Seve 4 Done Clear Cancel 44 4 8 2 Defining Tasks 1x3 Multiple user and owner login and role names may be entered using a comma delimited list and or all may be entered to specify all login or role names Task ownership specifications are ignored for study users with administrator priviledges datafax or study level These special users can view edit and delete any task including those created by other users Modes include the following e View when working in this mode no changes can be made to data or metadata queries and reasons and no changes are made to the work flow level e Edit in this mode changes can be made to data and metadata as permitted by user permissions New and modified metadata are saved at the current level of the data record and the level of the data record itself remains unchanged e Modify in this mode the work flow level is changed to the specified sign off level but only for those data and metadata records that are modified Thus it is possible for data and metadata records to end up at different levels Validate in this mode the work flow level of data and all metadata records is changed to the specified sign off level when
17. ID must be Sender ID NA programmed into the sending fax machine if RACHO Om Fis Dac 8 18 52 08 2006 not it will be displayed as NA not available The Fax Name is a unique identifier created by DataFax for each CRF page oa 7 3 Entering Refaxed CRFs It is not unusual for a CRF page to be corrected and refaxed For each new record DataFax checks to see if the keys ID Plate and Visit match an existing database record If a match is found you will be asked if you want to load the existing data record including reasons and queries into the data entry window This will allow you to compare the newly arrived CRF page with the current version of this data record in the study database DataFax will not allow you to enter a matching record into the database without first loading the existing data record When you save a matching record you will be updating the existing data record with any changes you make and the new CRF image will become the primary image associated with the data record The old image is not deleted and can be reviewed at any time by selecting Page Review Images or the image count button in the bottom right corner of the iDataFax window The Review Images dialog shows the date and time each image arrived and allows you to change which image is classified as the primary copy correct keys if an image has become attached to the wrong data record or delete images that are no longer needed 83 iDataFax U
18. Incomplete or Pending To open this page with it s new keys check the box below Pending Cancel _ eeeee_ee 38 If the new page has differ ent data fields from the old one the existing data queries and reasons can not be transferred and must be discarded If this is the case a warning message is displayed as illustrated in this dialog Click cancel if you do not wish to continue or one of the Save options Final Incomplete or Pending to proceed with the key change If you check Remain on this page when it is saved the page will be opened in it s new location This is recommended In this example only the patient ID is being changed Since the pages are the same they will have the same data fields and thus it is possible to transfer the data record to the new keys Click cancel if you do not wish to continue or one of the Save options Final Incom plete or Pending to proceed with the key change New keys already exist but pages are compatible iDataFax Change Keys OK You are about to change the patient from 3002 to 3003 Warning A record with these keys already exists with images 1 the primary is older than the current Status pending Created April 29 2007 11 15 31 PM Modified April 29 2007 11 15 31 PM Options keep the existing primary record The current data and metadata will be deleted but all images attached to the current record will
19. Review review faxed CRF pages entered by other users Level 2 Fax Review raise faxed CRFs from level 1 to level 2 To read the task instructions before Lost Record Review maa launching it select the Instructions MedDRA Coding button Medication Review brand amp generic names for baseline medications New Query Replies review replies from clinical sites New Reasons review reasons entered by Clinical sites To perform a task double click it in Quick Review review records you entered today the list or select it and click OK Review Screening check patient eligibility Site Monitoring source verify patient data Only tasks assigned to your login or study role will be listed in this dialog ax Instructions Cancel After selecting a task iDataFax sends a request to the study server to get data records that match the task specifications and then displays the number of records found along with the task instructions as illustrated below 42 4 8 1 Performing Tasks Task Instructions iDataFax Select by Task MedDRA Coding adverse event coding 1 make sure AE description has been entered correctly 2 tab into the Ist coding field coding is automatic if description matches MedDRA Instructions ae specified when the otherwise use the lookup table to select a MedDRA code task is created but can subse 3 changing the AE description will force recoding quently modified Task Records Instructi
20. Select Mode Merge if the input file includes both new and replacement records Among the Queries options we recommend that you resolve missing and illegal value queries if a legal value is imported otherwise the queries will not correspond to the corrected values and will likely confuse users None of the other query problem types can be logically auto corrected in this way and thus remain unchanged Queries can also be created automatically during import to flag missing and illegal values If these options are selected existing queries will not be modified or replaced new queries will only be created for fields that do not already have a query Selecting the Add Reasons option adds the reason Set by iDataFax Import to database fields that are changed when a replacement record is imported Reason status can be set to Pending review or Approved requiring no review but reasons can only be approved is the user has permission to approve reasons on the records being imported If this is not the case reasons are created with the Pending status Reasons that are created during import replace any existing reasons on the fields 105 iDataFax User Guide that are changed The previous reasons are then only available in the audit trail report or by selecting Show History of all Changes in iDataFax 8 Use the Task Set option to review the imported data records when import is complete The task set can contai
21. View 8 1 Introduction In Data View only one data record is displayed at a time but in List View all data records for a selected CRF page can be reviewed in a spreadsheet where each row is a data record and each column is a data field This view is useful for comparing data records searching for particular values or scanning for data problems Outlier values can be identified by sorting the spreadsheet on any column just click on the field name at the top of the column As in Data View the cells in the spreadsheet can be color coded to identify illegal values red outstand ing queries blue pending reasons and query replies orange approved reasons and query replies green and blank optional fields yellow Queries reasons and missing value codes are displayed in the lower left corner when a cell is selected that has these attributes and any images associated with a data record can be reviewed when a record with images is selected Unlike Data View List View does not support data entry but double clicking any cell in the table will switch to that data field in Data View where changes can be made Selecting the Return to List View button in Data View will take you back to the original cell in List View Any changes that were made to the data record or to it s queries and reasons while in Data View will be displayed when you return to that record in List View All data records are retrieved from the DataFax server when you se
22. View is first invoked it displays the status of the entire study database The results displayed in the tables and graphs can be filtered by study Site Patient ID study Assessment or visit and CRF Page In each case the legal entry is a number e g site number not site name The button to the right of each entry widget can be used to display and select valid entries for each specification except patient ID A list of values and ranges can be entered e g Site 1 9 21 30 44 81 82 Click the Update button to apply the current filter and the Clear button to remove all filter specifications After clicking Update any filter specifications will remain in effect for the duration of your login session To reproduce status for the entire study database select the Clear button and then the Update button 10 4 Links You can jump to the records displayed in any cell of the table including row and column totals by double clicking the cell Double clicking a cell in the Data table will create a Task set containing the records in that cell and open them in Data View Double clicking cells in the Queries table opens the task set in Queries View and double clicking cells in the Reasons table opens the task set in Reasons View Of course this only works if the user has permission to use these views 10 5 User Permissions The information displayed in Status View depends on user permissions The tables and graphs include only records the user has permission
23. a Save button Final Incomplete or Pending is selected regardless of whether or not any changes were made to data or metadata e DDE In double data entry mode the current data values and metadata are hidden until the user exits each data field whereupon the value entered is compared with the current value in the database If they differ a dialog appears asking the user to select the correct value The user must tab through all data fields before the record can be saved On save the data record and all metadata records move to the sign off level Field List DDE Status on This Page can be used to check the changes made so far and the data fields that remain to be entered on the current data record Sign off level is a number 1 7 which is stored as a special field DFLEVEL in each data and metadata record for work flow management New data entry is typically saved at level 1 Higher levels are used to signify that some review task has been completed analogous to moving paper CRFs from one persons inbox to another In the example above double data entry is performed by selecting records from level 1 and saving them to level 2 Thus each record will only be double entered once unless it is returned to level 1 by some event like a refax The task set returned to each user depends on their role permissions and equals the intersection set created by the task retrieval criteria and the user s permissions Thus you can not grant extra permissions
24. be saved as secondaries C make the current record the new primary The existing data and metadata will be deleted but ail images attached to the existing record will be saved as secondaries C Cancel 39 4 6 Correcting Key Fields If a data record already exists with the new keys you can either cancel the key change or continue by selecting one of the 2 conflict resolution options If you chose to keep the existing primary record it will not be changed in any way and the current data record with all of it s queries and reasons will be deleted The only thing that will move to the new keys will be any images from the current page If you chose to make the current record primary it will be moved with all of it s queries reasons and images to the new keys and the existing data record with all of it s queries and reasons will be deleted Only images will be preserved from the existing record and they will become secondary iDataFax User Guide If a data record already exists with the new keys and the data fields on the New keys already exist and pages are incompatible current page differ from those on the Skaka iDatafax Change Keys existing page you l can either cancel the You are about to change key change or j the page from 002 to 003 continue gt the patient from 3002 to 3003 If you chose to Warning A record with these keys already exists with continue the existing
25. building a set of blank screens does not automatically put blank records into the database Two examples are illustrated below Select Raw Data Entry example 1 P iDataFax Raw Data Entry Sign off Level 1 a M Enable Edit Checks Patient IDs 55034 55039 This example creates data entry Assessments 0 records for visit 0 plates 1 and 2 for Plates 1 2 each of patients 55034 to 55039 12 records in all of Cases Select Raw Data Entry example2 ID ataFax Raw Data Enty Sign off Level 1 B Enable Edit Checks Patient IDs This example creates 100 data entry records for visit 0 plate 1 The patient IDs have not been specified and thus Plates 1 must be entered before each record is of Cases 100 19 saved C Assessments 0 81 iDataFax User Guide Select Define Tasks iDataFax Define Tasks Task Adverse Events Description these are high priority records Instructions Enter all AE reports before the end of each work day To define a new task select User Roles Data Manager New Task from the Task Logins button and then complete Onnes Rakes the task definition dialog This example shows a task Logins jack created by jack for users Created with the Data Manager modifie SsSCS 7 ETC lt S S role Since jack owns the task only he can modify it Sign off Level 1 ig FA Enable Edit Checks S
26. but remain at work flow level 0 82 7 2 Entering New Records The check box Enable Edit Checks can be used to enable or disable edit checks during new data entry Typically edit checks are enabled during new data entry but you may want to delay them to a later stage in your data management work flow process 7 2 Entering New Records Data entry is performed as already described for the Data View The main difference is that ICR will have already completed many of the data fields and thus the task is to compare the ICR reading with what was written on the CRF page and to correct any ICR errors and enter any text fields which are not read by ICR If NA or other missing value codes have been written on the CRF the corresponding missing value code can be selected from the Field menu or using the Missing Value widget in the bottom left corner of the screen After applying a missing value code in either of these ways keyboard shortcut Control M Command M on Mac OS X can be used to apply the same missing value code to other data fields If explanations have been printed in the margins they can be entered using the Reasons widget also located in the bottom left corner of the screen If you need to know when a CRF page arrived or where it came from select Context from the Page menu Page Context aAA iDataFax Context Fax Name 0649 0005001 In this example the current CRF page is page l Page 1 of 1 1 of a 1 page fax The Sender
27. e the database plate 2 If imports from the same source recur the mapping of input fields to study database fields described in the next step can be saved to a mapping file and reused 3 When the input data file is selected the first 3 records are displayed in a preview window 4 The input field delimiter must be one of comma or tab 101 iDataFax User Guide Having field names in the first input row is useful as an aid to field mapping but it is not necessary If the date format used in the input data records differs from the format used in the study plate enter the input date format to convert dates to the format used in the plate 7 If the input file is very large specifying a small number of records to preview allows you to quickly verify that the mapping and data appear correct before loading all of the input data records 8 To proceed to the next step select the Next Map data fields button in the lower right corner of the dialog oo Step 2 Map Data Fields Next Map Data Fields ANA iDataFax Import Data from Users jack tmp ScreeningData_150910 dat Map input data fields to DataFax plate fields by dragging fields from input to DataFax plate or using the arrow buttons ScreeningData_150910 dat Plate 001 Blood Pressure Screening Visits input Data Fields Input Data Fields Generic Name Ocscription Type Legal Values Format Value if not mapped l 1 DFSTATUS choice 1 3 7 1 2 2 DFVALID c
28. edit operation performed Redo Redoes the last edit operation performed Cut Copies the contents of the current field to a buffer then clears the field Copy Copies the contents of the current field to a buffer Paste Copies any data previously cut or copied to the current field at the current cursor location Clear Removes any data from the current field Select All Selects all data in the current field 4 16 3 Select Menu The Select menu is used to select patients and data records for review Selected patients and records are tagged with the letter T for task All Records Cancel the current selection criteria and return to the normal display showing all patients and records By Task Select data records using a pre defined task By Data Fields Select data records by site patient assessment page level status etc as well as by metadata queries and reasons This option requires permission for Data with Select By Data Retrieval File Select data records using a pre defined data retrieval file filename drf Define Tasks define tasks for oneself and or for other users Change Mode amp Level DataFax supports 4 working modes and allows records to be moved to speci fied work flow levels The supported modes include o View when working in this mode users can review patient data but can not make any changes o Edit in this mode changes can be made as permitted by user permissions but the work flow level of all
29. entered is invalid Confirm that your internet service is functioning properly Confirm that you have correctly typed the DataFax Server name in the login dialog Otherwise contact your iDataFax Study Coordi nator or System Administrator 130 Message Possible Cause Solution Message Possible Cause Solution Message Possible Cause Solution Message Possible Cause Solution Message Possible Cause Solution 13 2 Common Error and Warning Messages Unable to connect to DataFax server Check if DataFax EDC Service is running DataFax is not running on the specified server or DataFax EDC Service is not running Contact your iDataFax Study Coordinator or System Administrator and confirm that the DataFax Server and DataFax EDC Service is running properly Unable to get a list of studies from the server The user has not been given access to any studies in the DFsystem tool or the iDataFax server or DFedcservice is not running Contact your iDataFax Study Coordinator or System Administrator Error Unable to load study setup file The study Setup file does not exist or is empty Contact your iDataFax Study Coordinator or System Administrator Unable to load patients Please contact iDataFax system administrator The DFcenters file does not exist or is empty or the user does not have permission to access patient numbers due to restrictions defined in their DFsystem us
30. fax or email Quality Control QC reports to the sites they may respond by writing directly on a printed copy of a report and faxing it back to the DataFax system Returned QC reports are not patient CRFs and thus are not displayed in a patient binder They can however be processed in Fax View just like data records and saved in the study database with key fields ID equal to the QC report number composed of the site number and QC report creation date and Sequence equal to the QC report page number Any QC reports that have been saved in this way can be reviewed in List View 108 8 13 List View Menus If you have permission to modify returned QC reports you will be able to correct any errors that might have been made when the key fields were entered To make corrections first use Select Change Mode amp Level to set mode to anything except View and then use Page Change Keys to bring up the Change Keys dialog Like patient data records QC report pages can be filtered using using the Search dialog and the current set of pages can be printed or saved in a PDF file by selecting these options from the File menu Work flow tasks can also be performed on QC reports in List View For example new QC reports will typi cally be saved at level 1 when they arrive in Fax View Someone may then have the task of reviewing them and moving them to level 2 to indicate that they have been reviewed To perform this task use Select Ch
31. field For example a missing or illegal value query can be resolved by entering a legal value In these cases the field will change from blue to green and no further action is required Other queries ask a question to which a reply is expected These queries are identified by the phrase reply required at the top of the Query metadata window When a reply is entered the field turns orange and query status changes to Pending to indicate that the reply is ready for central office review You can reply to an outstanding query or modify the reply to a pending query but you can not change the reply once a query has been resolved 25 iDataFax User Guide Field Reply to Query e99 Field 4 Valvular HD Duratn Yrs iDataFax Reply to Query Value 45 Problem Other Details Does this patient have any limitations or problems related to this heart valve defect New Reply No Cancel The Query Metadata Window Query Problem Other Details Does the patient have any limitations or problems related to this heart valve defect Reply jack May 8 2006 5 42 18 PM No Status Pending review Created pat May 8 2006 11 19 24 AM Resolved To reply to a query click the button in the upper right corner of the Query metadata window or select Field gt Reply to Query The Query reply dialog shows Field the current field and it s value Problem the problem type Missing Illegal Inconsist
32. file is added to the DataFax fax archive 61 iDataFax User Guide Page Context iDataFex gt Context Fax Name 1045 0012001 Page 1 of 2 Sender ID iDataFax Submit PDF jack Received On Tue Nov 21 40 53 2010 The Context dialog available in Fax and Data views shows the date and time the page was received by the server along with the method and user as illustrated here 4 15 Importing Patient Documents Unlike Submit PDF described in the previous section which sends a PDF to the DataFax server for processing in Fax View users with permission to Import patient documents can import a PDF file and immediately attach each page to the appropriate data record The imported pages may be supporting documentation e g letters reports death certificates etc or copies of paper CRFs or worksheets containing patient data This feature is launched by selecting Import Patient Documents from the Patient menu in Data View It first displays the standard file selection dialog and then when a PDF has been selected presents the import dialog illustrated below The import dialog contains 2 main sections a window for reviewing the PDF pages on the right anda spreadsheet for identifying the data records they belong to on the left 69 4 15 Importing Patient Documents A iDataFax Import Patient Documents from Users jack J ScannedFiles DemoStudyletters pdf Selec
33. final incomplete at any time Search Data J Questes Reasons By program during the study and still meet these Program Of mkdrf jnl xu whoami v 1 image yes s final incomplete d 2 criteria today d 2 Example 5 Search by Program DFmkdrf jnl If instead of performing double data entry it is considered adequate to just review level 1 data entry records and move them to level 2 the same retrieval criteria can be used with Vali date instead of DDE mode i Task Fax Pass 2 Mode Validate 4 Sign off Level 2 iH wv Enable edit checks Search _ Data L Queries _ Reasons By program Program Of mkdrfjql xu whoarni y 1 image yes 4 final incomplete d 2 48 Example 6 Search by Program DFmkdrf jnl Task Today Mode Edit rey Sign off Level 1 ve W Enable edit checks Search _ Data J Queries Reasons F By program Program Ofmkdrf jal u whoami t today Example 7 Search by Program DFmkdrf ec Task Edit Checks Screening Mode Validate ag Sign off Level Ww Enable edit checks Search Data Queries D Reasons By program Program Ofmkdrfec P 1 E ALL y 1 Example 8 Search by Program DFmkdrf ec Task Edit Checks initials Mode Edit aa Sign off Level 2 wf Enable edit checks Search lt Data J Queries Reasons F By program Program Of mkdef ec P 1 102 E Checkinit 4 8 2 Defining Tasks Users sometimes forget exactly what case they were working on earlier in the day but want to retrieve i
34. format and legal values List All Outstanding Problems on This Page lists each field with a problem on the current page including required fields that are blank illegal values outstanding queries and rejected reasons List History of All Changes on This Page runs the DataFax audit trail report DF_ATmods and displays the results in a separate window The report includes all changes made to data fields on the current page List DDE Status on This Page this option can be selected at any time during the performance of a double data entry task It lists the fields that have not yet been entered and the fields that have been changed from their previous value 4 16 8 Field Menu The Field menu provides field level functions which depend on the state of the current field and the permissions you have been granted by the study sponsor including Mark Field Missing used to assign a predefined missing value code to the current field or to remove a missing value code previously assigned Missing values may also be selected using the button on the Missing Value metadata window in the bottom left corner of the screen After applying a missing value code in either of these ways keyboard shortcut Control M can be used to apply the same missing value code to other data fields Revert to Last Save used return the current data field to the state it was in when the page was opened this includes both the value of the field itself as well as the existenc
35. has been completed Any ICR errors must be corrected all text fields must be manually entered and comments written in the margins should be reviewed and perhaps entered as reasons or missing value codes Use the Tab or Return key to move forward through the data fields and Shift Tab or Shift Return to move backwards This will ensure that you trip all field entry and exit edit checks designed to assist data entry When necessary the 2 screens will scroll together to show the same data fields in the data and CRF windows Occasionally you might also want to use Control T or Control B to scroll the CRF image screen by itself to the top or bottom respectively to check something that has scrolled by Alternatively if you have a large monitor the screen can be split vertically to display a full page on each side see File Preferences While entering new records clicking Previous Set moves backward in the list of new records to get an earlier set while clicking Next Set moves forward in the new record list to get the next available set Records that have already been entered or that are currently being entered by another user will be skipped The Next and Previous direction depends on whether you selected oldest to newest or newest to oldest in the record selection dialog see below The meaning of Set also depends on what you selected in this dialog it could be one or more faxes or a specified number of records
36. i f yanri T depanment has installed a proxy Login Name jack server to filter requests sent to other servers on the internet click the button to the right of the DataFax Server name to register the proxy server You will yn need to contact your IT www catafax com department for the necessary information iDataFax remembers the most recent servers and proxy servers you have used so you should only need to enter this information once but your login name and password needs to be entered each time you login The first time you connect to a DataFax server you will be prompted to change your password All data entered and modified is recorded under each users login name Thus be careful to protect your login name and password iDataFax includes password aging an FDA regulatory requirement Password expiry may be anytime between 1 9999 days and is set by the DataFax Administrator in the DFsystem application After the expiry period has elapsed you will be prompted to reset your password the next time you login iDataFax User Guide The Study Selection Dialog Select a study and click OK or startup DataFax router Number Name a 8 t iDataFax DataFax Server idemo41 datafax com Version 4 1 0 Login Name jack Password cecceese ECIC Bypass NASCET ACE DEMO 153 devel for 253 Status not available dwt compieted and archived available in restricted mode dwt will be back up at 2p
37. iDataFax User Guide Chapter 12 User Preferences 124 File Preferences User jack Study DEMO 253 E Data Window _ expand all assessments when a patient binder is opened display first page when an assessment is opened _ advance to next field after current field is completed wv open first task record when task set is built warn before opening next patient when traversing task records _ retain scroll position when traversing task records E Image Window m auto open close as image is available unavailable Display method toggle screen between data and image views O split screen data left image right split screen image left data right split screen data top image bottom split screen image top data bottom sticky toggle retain data or image view across records E Record List Show assessment number label O number label Show page number label number labe Show site number label number label Record navigation patient binder record list E Query Defaults Use external O internal Type clarification correction List View show field name generic unique _ number name show coded field code Q label show date field default calendar julian apply imputation rule show field color coding _ expand text fields Fax View During duplicate resolution display image review dialog _ when the existing reco
38. if this preference is selected the first data record is opened automatically when a new task is selected otherwise users must open the first task record manually by selecting the desired patient binder warn before opening next patient when traversing task records this preferences is only relevant to users who have access to record selection tasks and is used to ensure that the user is aware of tran sitions from records for one patient to records for a different patient retain scroll position when traversing task records this preferences is only relevant to users who have access to record selection tasks It is useful when the task involves a review a fields near the middle or bottom of the page as it avoids the normal scroll to the top of each new page 12 2 Image Window auto open close as image is available unavailable if this preference is selected faxed scanned CRF pages or other images are automatically displayed when a page having such images is selected When this preference is selected the display method is determined by which of the following options is selected toggle screen between data and image views switching between data and image views is performed using the blue image button in the bottom right corner of the screen but the data view will always appear on switching to a new page in the patient binder split screen data left image right occurs if an image is attached to the current data record split screen image
39. integer value truncated of a field e g to find a patients current age in years at visit date VDATE using the patient s birth date stored in field BDATE number age int VDATE BDATE 365 25 Use julian to specify a date e g to find records where Screen 1 Date occurred after Nov 15 2008 S1IDATE gt julian 2008 11 15 Use length to test field length e g to find initials shorter than 3 characters length PINIT lt 3 Use month to test for a month in a date e g to find records created in June of any year month DFCREATE 6 93 iDataFax User Guide substr s1 n1 n2 Use substr to test a sub string of a specified field e g to find records where the middle patient initial is X substr PINIT 2 1 xX time hh mm ss Use time to specify a time e g to find records created after 6pm time DFCREATE gt time 18 00 00 today Use today to test against todays date e g to find records created today julian DFCREATE today tolower s Use tolower to convert a string to lower case before testing it e g to find records containing inuit in the Race Other field ignoring case tolower RACEOTH inuit toupper s Use toupper to convert a string to upper case before testing it e g to find records containing INUIT in the Race Other field ignoring case toupper RACEOTH INUIT
40. left data right occurs if an image is attached to the current data record split screen data top image bottom occurs if an image is attached to the current data record split screen image top data bottom occurs if an image is attached to the current data record Sticky toggle retain data or image view across records switching between data and image views is performed using the blue image button in the bottom right corner of the screen and the last selection will remain in effect on switching to a new page in the patient binder 12 3 Record List Show assessment number label number label this preference determines how assessments are identified when a patient binder is opened Each patient assessment has both a number and a descriptive label Both number and label or only one of these can be displayed Show page number label number label this preference determines how the pages within patient assessments are identified when an assessment is opened Each page has both a number and a descriptive label Both number and label or only one of these can be displayed Show site number label number label this preference determines how sites appear in the record list Each site is assigned a number and a descriptive label during study setup Both number and label or only one of these can be displayed 126 12 4 Query Defaults 12 4 Query Defaults Use external or internal this preference is only relevant to users who are
41. main iDataFax window It provides access to all patient binders for data entry and review 4 1 Patient Binders The Data View is organized like a bookcase full of patient binders The binders represented by people icons are nested under the clinical sites and displayed in a list on the left side of the window Only sites and patient binders you are allowed to work in will be visible Double clicking a site opens it revealing the patient binders and double clicking a binder opens it reveal ing the different sections one for each patient assessment Assessments can be opened by clicking the arrow or double clicking the assessment label This reveals the pages belonging to each assessment Only one patient binder can be open at a time but you can open as many assessments within the binder as you wish Double clicking the label for an open assessment patient or site will close it Opening a new binder or a new site will automatically close the current one 33 iDataFax User Guide Different icons and colors indicate the status of patients assessments and pages Patient icons include e of Empty head a new binder not yet started e Green head no problems all pages entered so far are complete e t Red head one or more pages are incomplete e k Yellow head one or more pages are pending and no pages are incomplete L f L head all pages completed so far have been marked lost i e unavailable Assessmen
42. not displayed in the data field it only appears in the Missing Value metadata window when the field has the focus in the data window After applying a missing value code to a data field in either of these ways keyboard shortcut Control M Command M on Mac OS X can be used to apply the same missing value code to other data fields If you need to remove a missing value code so you can enter a real data value select the No Code reset option which appears at the bottom of the list of missing values Missing Value Metadata Window Note y Missing Value Not Available If a data field has been defined as essen tial you will not be able to select a missing value code 3 6 What are queries and where do they come from Queries are questions about data values that you have entered or failed to enter They are always attached to a data field either manually by someone at the study coordinating center or automatically by edit checks and other programs that check for problems There are 4 types of queries 1 Data Correction Queries request a correction to a data value or a blank field 2 Data Clarification Queries ask you to reply to a question 3 Overdue Visit Queries identify study assessments which should have been performed by now 4 Missing Page Queries identify required pages that have not been completed Data Correction and Data Clarification queries are classified into one of the following general problem ty
43. of the Preferences dialog available under the File menu can be used to customize the appearance of List View Preferences can be used to turn field color coding and text expansion on or off determine whether field codes or code labels are displayed select column labels generic or unique field names and field number and select the display format for date fields All selections made in the preferences dialog are study specific and will be retained across iDataFax sessions 8 3 Navigation To display the data records stored in the study database for a particular CRF page select it from the page list in the left panel Within the data table you can select any cell with a mouse click use the left right arrows to move across the fields in a data record and user the up down arrows to move across data records The default record sort order is ascending by patient ID and ascending within patient by assessment number The rows of the data table can be sorted on any column by clicking the column label Each click toggles the sort order between ascending and decending Use shift click to sort on a second column in the current sort order within the currently sorted column 88 8 4 Working on a Task The keys patient ID assessment page of the current record and the number of data records in the table are always visible in the upper left corner of the screen The work flow level at which the current record was last saved appears along with t
44. or revised it s Status Approved status is set to Pending On review by central office Created jack May 8 2006 1 04 23 AM staff status may be changed to Approved or Reviewed dwt May 9 2006 11 18 46 AM Rejected e Created who created or most recently revised the reason and when e Reviewed who most recently set the reason status to Approved or Rejected and when To add a new reason or modify an existing one either click the button in the upper right corner of the reason metadata window shown above or select Field gt Add Reason for Data Value 22 3 5 Can use standard missing value codes Field Add Reason for Data Value iDataFax Reason for Data Value Field 4 Valvular HD Old value Yes The add reason dialog shows Reason Patient has a congenital mitral valve defect e Field a label describing the current field e Old Value the value the jack November 25 2009 13 13 45 field had when the page Newvalue No o E Ap a e Reason the current reason id a if any for the old value and Reason Patient s mitral valve defect was surgically corrected at who created it and when age 6 and her heart function is now normal e New Value the current value in the data field e Status new reasons are created with status pending unless the user has permis sion to approve reasons e Reason a text widget where a new reason can be entered _ Revert to Old Cancel Some fields may require a r
45. previous report However by switching to the History list you can review the output from all reports you have run since login The run history is not saved between login sessions The current output in the report window can be printed or saved in PDF HTML or text format by selecting any of these options from the File menu 111 iDataFax User Guide 9 6 Saving Report Lists A list of commonly executed reports can be saved for later execution by specified users and or users with specified roles You can also specify the user and roles that are permiitted to own and thus modify each report list you define The permissions granted at this level do not over ride the permissions defined in user roles If a user lacks permission for any report in a report list the entire list will be unavailable in iDatafax A report list is defined using Select Define Report List and is subsequently accessed using Select Report List Reports and report options may be added to a report list manually in the dialog shown below or the current history list can be used as a starting point and then modified Begin by selecting the button at the right end of the List Name field at the top of the dialog Then select New Report List to define the list manually or New Report List from History to begin with the reports contained in the current History list The following example shows a list of reports used to create and send QC reports to the study sites ea
46. reason is approved the field will turn green If the coordinating center has questions they will add a new query to the field and it will turn blue Missing Values Some studies use standard missing value codes e g NA not available ND not done etc which can be applied to data fields when a data value can not be entered If standard missing value codes have been defined a code can be selected for the current data field by clicking the button in the Missing Value window bottom left corner of the screen Fields with missing value codes turn green and the code label is displayed in the Missing Value window when you move into the field You will not be able to add missing value codes to any field that has been defined as essen tial by the study coordinating center Saving Your Work After making changes to data fields queries or reasons you must select one of the Save buttons at the bottom of the screen to transmit your changes over the internet to the study server If you are interupted during new data entry and do not want to loose your work you can save a partially completed page using the Pending button If you have completed the page and there are no illegal values red or outstanding queries blue you can save your work using the Final button other wise you will need to use the Incomplete button The data is not stored on your personal computer and will be lost if you do not transmit it using one of the Save buttons You will be warned if
47. records and data fields for the current page e Refresh update all data records for the current page from the study server to get new records that may have been added or changes that may have been saved since the view was opened 8 13 2 The Show Menu The Show menu is used to select the study page types and individual records to be displayed in the List view table The options include All Pages show all page types defined for the study Task Pages show only those page types included in the current task set All Records show all data records for the currently selected page type Task Records show only those data records included in the current task set 109 iDataFax User Guide Chapter 9 The Reports View 9 1 Introduction Reports will appear as an option under the View menu if you have been granted permission to run one or more of the standard DataFax reports or study specific reports Reports can be updated and viewed within the Reports View and can be printed or saved to a PDF HTML or text file The Reports View is illustrated below Figure 9 1 View Reports DataFax Reports E2 Data D Index to Standard DataFax Reports Queries Q DF ATerts nant sR set DF_ATfaxes ude Ai DF_ATmods Status S DF_CTerts List L 1 DF_CT pages DF_Cracs C Fom Report DF_INDEX 76 lines _Clear_ DF_CT visits DF_ICcenters Quality Control a DF_iCimages SS DF ICkeys DP_ocfax Fax or email QC report
48. records still remaining in the new queue will be displayed any already entered or now in use by other users can not be accessed 7 7 2 The Page Menu The Page menu includes the following options Save this menu item has pull rights for Final Incomplete and Pending which are equivalent to saving changes using the buttons at the bottom of the screen Revert to Initial State undoes all changes to the data queries and reasons on the current page Review Images this option is used to review all of the images attached to the current data record and is only available if the current record has more than one image Change Bar Code as described above this dialog is used to make corrections to the values of bar coded key fields Delete This Page this option deletes the current image from the new fax queue It can not be undone within iDataFax but is reversable by a DataFax administrator Context this option shows the arrival date and time and fax sender ID of the current CRF page List All Outstanding Problems on This Page lists each field with a problem on the current page including required fields that are blank illegal values outstanding queries and rejected reasons List History of All Changes on This Page runs the DataFax audit trail report DF_ATmods and displays the results in a separate window The report includes all changes made to data fields on the current page 86 Chapter 8 List View Chapter 8 List
49. studies you are participating in at that center thus it is possible to use iDataFax to participate in many different studies being run by many different coordinating centers In all cases the software will behave the same only the study data entry forms will differ 1 11 If don t like this or have time for it can switch to faxing DataFax is capable of supporting both EDC and faxing data collection forms within the same study with no additional study setup work Further the design of the paper forms and data screens are identical and are completed in the same step thus switching a clinical site from iDataFax to completing and faxing paper forms is certainly possible and provides a fall back position for sites that find EDC too time consum ing or problematic for whatever reason Of course it is also possible to move in the other direction switch ing from faxing to EDC 1 12 How do get started First you will need to download and install iDataFax following the instructions provided by the study coor dinating center On starting iDataFax you will see a login screen where you enter the name of the DataFax server at the study coordinating center your user login name and your password all of which will be provided by the study coordinating center If your login is successful you will then see a list of the studies in which you are participating at the coordi nating center with a status tag indicating whether each study is cu
50. to compare the old and new CRF images before reviewing and correcting any data fields when the revised record is saved use this option if you want to delay image comparision until after reviewing correcting and saving the data record 127 iDataFax User Guide 12 8 Auto Logout e Exit after 10 minutes of inactivity study administrators can specify a default and maximum time period and thus the default may be something other than 10 minutes Users may change the default to any value up to the maximum An automatic timeout after a period of inactivity is needed to meet regulatory requirements and protect patient confidentiality Remember that any changes to the current page that have not been saved will be lost if a login session times out 128 Chapter 13 Appendix Chapter 13 Appendix 13 1 Terminology This section explains some of the terminology used in this manual Assessment Electronic Signa ture Final Incomplete Page or Plate Patient Patient Binder An assessment is a set of data collection pages which are completed together at a specified time per instructions in the study protocol Each assessment repre sents a clinic visit a home visit medical tests medical records patient question naires etc Your electronic signature has two parts your login name and your password You must specify both parts when you log into the study s DataFax server All data collected is recorded under
51. to double click on the query in the Queries table To return to the queries table after reviewing a query in the Data view select View gt Queries 74 Chapter 6 The Reasons View Chapter 6 The Reasons View w iDataFax File View Show Reason Help re aA Data i iDataFax jack Demo Study Queries Site 1 5 reasons 1 rejected and 2 pending Site Patient Field Reason x Status Site 1 General Hospital 1001 Screening Visits Blood Pressure Screening Screen 2 Date Pending review jack May 11 2006 12 51 54 AM Did not return for the second screening visit 1002 Baseline Medical History l Hypertension Duratn Yrs Approved dwt May 11 2006 2 27 31 PM Patient says he had his blood pressure under control until about 6 months ago when he became dissatisfied with side effects from his antihypertensive meds wv 1002 Baseline Medical History 4 Valvular HD Duratn Yrs Approved dwt May 9 2006 11 18 46 AM Patient has a congenital mitral valve defect surgically POSEN EEE S Be Se x 1002 1 Month Follow up Monthly Follow up Reading 1 systolic BP Rejected dwt May 16 2006 5 29 30 PM Not done 1002 1 Month Follow up Monthly Follow up Weight in kg Pending review jack May 13 2006 10 53 57 AM Patient refused to be weighed The Reasons View is is used to review reasons that have been added to explain unusual values add comments or explain why a data value was changed This is analogous to comments wri
52. user is able to retrieve the records Records the user does not have permission to get or which are currently locked by another user can not be batch validated e Record status is final incomplete pending or lost New records can not be batch validated e The records are currently at levels for which the user has modify permission e Users can only move records to levels for which they have write permission There are 3 options move the current page only move all open pages for the current patient and move all records in the current task set i e records flagged T or t 53 iDataFax User Guide Select Batch Validate gt DataFax Batch Validate Change record level to 3 19 In this example all open pages for the current patient will be moved to work flow level 3 when the Apply button is selected The open pages Oa open pages for current patient could include assessments opened by 1 select All currently selected T and t records ing them in the record list 2 using Patient Expand All Assessments or 3 as the result of a predefined or adhoc task _ S Cancel When the Apply button is selected the specified records are moved immediately No edit checks are trig gered 4 10 Using Lookup Tables Some tasks require selecting an item from a pre defined lookup table This functionality is implemented in iDataFax using an edit check to achieve the desired behavior For exampl
53. will be hidden for any data fields you are not allowed to see Selecting Data Fields Data fields columns can be selected and reordered using the Field Selec tion dialog available under the Select menu Selecting Data Records You can search for data records with specific attributes e g illegal values outstanding queries pending reasons etc using the Search dialog available under the Select menu Selecting Predefined Views Some users may have permission to define views consisting of selected data records and data fields for others to use Views are created using menu item Select Define Views and accessed using Select By View Making Changes to Data Queries and Reasons You can not modify data values queries or reasons directly in List view but double clicking on a data field takes you to that field in Data View where changes can be made if your permissions allow it To return to List View from Data View select the Return to List View button User Preferences The Preferences dialog located under File menu includes options for customiz ing List View including field color coding displaying codes vs labels date formats and column titles iDataFax User Guide 2 9 Status View The Status View uses tables and graphs to show the number of data records queries and reasons in the study database categorized by work flow level and record status 8080 iDataFax dwt localhost demo253 Status Pages awaiting revi
54. write mode DataFax and Study Administrators Only DataFax and study administrators can send pages to a restricted study If a study is also in read only mode or is disabled not even administrators can send pages to the study 11 4 Starting The Router Start the router by selecting the Fax Router button located on the study selection dialog that appears right after the iDataFax login dialog This button only appears if you have permission to use the router Figure 11 1 The main router window Iane iDataFax Fax Router jack idemo4 1 datafax com CRFID a 1041 0001001 1041 0002001 aces SEENELE 1041 0002003 1041 0002004 DotoFax 253 Bte 001 Visit 000 1041 0002005 Patient Patient Z 1041 0002006 Number Initials SAT 1041 0002007 FML 1041 0002008 1041 0002009 BLOOD PRESSURE SCREENING VISITS 1041 0003001 1041 0003002 seat oneenea Age 51 years Sex J male Race J Caucasian 1041 0003005 g Female g African Amencan 1041 0003006 Asian z 1041 0003007 o 1041 0003008 a E sie 1041 0003009 Study Plate Visit Preserve keys Zoom 100 B 1042 0002002 l 253 DEMO 253 el 1 0 Identify 21 routable pages 0 busy 1042 0002001 864x 1079 Each page shown in the page list on the left side of the screen is identified by an image name in format yyww ffffppp where yy is the year ww is the week ffff is the fax transmission ID and ppp is the page number within the transmission The router can be used simultaneously by multip
55. 0 o 12 Automatic Resolution of Data Queries l 13 Review Approve Queries and Reasons 42 44 50 50 51 52 53 54 56 58 58 60 62 66 66 67 67 67 68 68 68 69 70 71 71 71 72 72 73 75 75 75 75 76 76 77 79 83 83 84 84 85 85 86 86 87 87 88 88 89 89 90 95 97 98 98 8 11 Importing Data Records 8 12 Metadata Queries Reasons QC Reports and Lost Records 13 1 The Select Menu 13 2 The Show Menu Chapter 9 The Reports View 2 Report Types 1 9 5 Running Reports 9 6 Saving Report Lists 0 2 Level amp Status 10 5 User Permissions 10 6 New Fax Queue n a 10 8 Returned QC Reports plate 501 11 2 Router Functions 1 4 Starting The Router 11 5 The File Menu 11 5 1 Update Records 1 7 C0 00 Co O O y i h 11 5 2 New Stud 11 5 3 Close Router a 11 6 The Page Menu 11 6 1 Rotate 1 7 2 Move 11 7 3 Discard 12 2 Image Window 2 4 Query Defaults 12 5 List View pay pery Table of Contents 101 107 109 109 109 110 110 111 111 111 111 112 114 114 115 116 116 116 116 116 116 117 117 117 117 118 119 119 119 119 119 119 119 120 120 120 121 121 121 121 121 121 122 122 122 122 122 123
56. 06 10 53 57 AM You can filter the list of reasons by status outstanding approved and rejected and search for reasons with specified text strings Double clicking a reason opens the data view to the relevant page and puts focus on the data field with the reason 2 6 Fax View The Fax View is used to enter new data records from paper case report forms CRFs that have been faxed or emailed to the DataFax study server Pe Ee iDataFax User Guide L iDataFax File Edit _ Select Page Field Help ANA x dwt kepler datafax com DEMO 3 Fax 2 of 16 Data D Fax Name d Vist ot Queries 0924 0004001 1004 0 Reasons wT FA Reports Status Pationt List Initials FM l BLOOD PRESSURE SCREENING VISITS Sex Male Race Caucasian Fomale gt African Americar lic diastolic Screon 1 Date 21 01 09 Reading 1 160 A l Reading 2 160 100 Reading 3 160 104 i ss ee Ree Ieee OetaFax 263 Pisto 001 Visit 000 Next Set Previous Set Taras ee OTT OLOIS sa Query BLOOD PRESSURE SCREENING VISITS Race C Caucasian m Afican Amarican Reason for Data Value Screen Save v 0 gt 1 Missing Value First 2 boxes center number Fax view is identical to the Data view except that the list of patient binders is replaced by a list of faxed pages that need to be entered Fax View features include e Record Selection Options Typically users will chose to enter a fax at a time and request the olde
57. 0D8P1 S108 1 Screen 1 Read 1 number 30 150 16 S158P2 S158P2 Screen 1 Read 2 number 60 300 b K 17 10D8P2 S108P2 Screen 1 Read 2 number 30 150 X m AE Select all fields L Deselect all fields Apply Revert Cancel Fields can be selected or hidden using the check box beside each field and reordered by selecting a field and then moving it up or down using the arrow buttons at the bottom of the field list 89 iDataFax User Guide 8 6 Searching Data Records The Search dialog available under the Select menu can be used to find records within the current plate that meet specified criteria If the Filter option is selected the record list is reduced to those records that meet the search criteria when the Filter button at the bottom of the dialog is selected otherwise this button is replaced by a Find button and the focus simply traverses those fields that meet the search criteria each time the button is pressed The Search dialog can also be used to put data records from the current plate into a Task set After entering the record selection criteria selecting the New Task button will display a task confirmation dialog where the user can set Mode and Edit Checks options after which the selected records will be flagged with the T icon to show that they belong to a new task set The Add to Task button will then become active and can be used after entering a new set of record selection criteria to add more rec
58. 123 123 124 126 126 126 127 127 iDataFax User Guide 12 6 Screen Options 12 7 Fax View Options 12 8 Auto Logout 13 2 Common Error and Warning Messages 13 3 Programs 13 3 1 DFmkdrf jnl make DataFax DRF file from study journals 13 3 2 DFmkdrf ec make DataFax DRF file from edit checks 127 127 128 129 129 130 133 133 136 iDataFax User Guide iDataFax User Guide Release 4 2 0 0 Copyright 2011 Clinical DataFax Systems Inc All rights reserved No part of this publication may be re transmitted in any form or by any means elec tronic mechanical photocopying recording or otherwise without the prior written permission of Clinical DataFax Systems Inc Permission is granted for internal re distribution of this publication by the license holder and his employees for internal use only provided that the copyright notices and this permission notice appear in all copies The information in this document is furnished for informational use only and is subject to change without notice Clinical DataFax Systems Inc assumes no responsibility or liability for any errors or inaccuracies in this document or for any omissions from it All products or services mentioned in this document are covered by the trademarks service marks or product names as designated by the companies who market those products Sep 15 2011 Abstract This guide describes the iDataFax tool iDataFax U
59. Apprvd Total 0 5 5 53 53 1 28 19 47 1 51 13 65 3 1 15 19 2 6 5 ll 1 33 14 48 2 11 13 3 1 2 3 2 2 10 10 4 1 2 3 6 23 23 6 6 5 2 2 6 Total 5 1 37 29 72 2 162 29 193 7 1 44 52 Graphics by level by status Level 0 Level 1 Level 2 Level 3 Level 4 Level 5 Level 6 Level 7 Brending MiLost Mincomplete Mrinal MPending Miunresolved Giresonved E Study Users RAR Hs Too since iljack localhost iDatafax 2008 03 05 11 09 2 dwt localhost iDataFax 2008 03 05 11 13 3 dwt localhost Setup Tool 2008 03 05 11 10 4 angela localhost iDataFax 2008 03 05 11 12 Levei 0 Levei 1 Level 2 Level 3 Level 4 Level 5 Level 6 Level 7 WiPending rejected Wapproved Last update 3 5 08 11 13 AM 10 2 Level amp Status The Status View displays the number of data records queries and reasons that are currently stored in the study database categorized by the work flow level and status with which each record was most recently saved Status labels have been shortened as needed to fit within the tables but the full label can be seen by hovering over the table labels or selecting the Graphics by status option Work flow level O identifies new data records that were saved with pending status and queries for overdue visits Level 1 is typically used for new data entry leaving higher levels for various central office checks and reviews 115 iDataFax User Guide 10 3 Filtering The Status Report When the Status
60. Coding expand text fields if cells in the data table are too small to display the entire data field selecting this preference will expand the cell and display all that it contains when the cell is selected 12 6 Screen Options Background color black white or color this preference determines whether data fields are displayed on a black white or color background Color is only useful if color CRFs have been imported in DFsetup to create the data screen backgrounds Black is recommended even with color CRF back grounds to reduce eye strain and make data fields and color coding stand out more clearly Background type different versions of some or all of the CRF pages can be imported during study setup For example some CRF pages might be available in multiple languages This preference allows the user to select the version of the CRFs to be used for both the data entry screens and when printing CRFs or creating PDFs 12 7 Fax View Options When a CRF page is refaxed users perform duplicate resolution by loading the existing data record comparing it with the new fax image and correcting any data fields that need to be updated During this process users can select the image count button at the bottom of the screen to review the previous and new CRF images Alternatively either or both of the following preferences can be used to display the image review dialog automatically when the existing record is loaded useful if you always want
61. Images 0 no images data record will not be Status incomplete Created April 29 2007 11 46 35 PM Modified April 29 2007 11 46 35 PM Queries 11 outstanding changed in any way The data on the current page can not be moved because Warning Page 002 and 003 are not compatible the data fields are All data queries and reasons on this page will be discarded and the different on the new images attached to the current page will be moved to become page thus all data secondaries attached to the existing data record queries and reasons on the current page will be discarded The only thing that will move to the new keys will be any images e_ _ _ _ cc from the current page and if the existing page already has images all moved images will become secondary Remain on this page when it is saved OK w Cancel 4 7 Images of CRFs and other Documents DataFax can receive and link scanned or faxed images to data records An image could be a faxed copy of the original paper case report form or a supporting source document from medical records Each image must be linked to one and only one data record Multiple images may be linked to the same data record e g all faxed copies of the original CRF page as corrected over time One image must be designated as the primary copy This is the image that will appear along with the data record when the screen is split in data and list views All other images have
62. TUDY DFPLATE OFSEQ 10 PINIT AGE SEX RACE RACEOTH SIDATE SiSBP1 SIDBPL S1S6P 5108P2 S1S8P3 S108P3 S20ATE pinati 01001 LKJ 66 1 2 15 09 10 142 110 146 110 144 110 2 gioa KAH 62 1 15 09 10 138 98 140 100 142 100 i3 01003 sha 37 1 1 15 09 10 168 102 164 102 164 104 ws 01004 JHG 595 2 1 15 09 10 MMM 1s 10S se 108 Qs 01005 WKD 57 1 1 15 09 10 148 E 146 ios 144 104 eee _ Back Map data fields Valid 4 5 records Get All AutoCorrect Cancel _ _ Next Save data v The spreadsheet illustrated above displays each data record Scrolling left and right allows you to verify that all fields have been mapped correctly The Get All button at the bottom of the dialog indicates that we are looking at the number of records that were specified for Preview Selecting Get All loads the remaining input records as illustrated in the example below Problem fields are identified by color using purple for invalid values which prevent the record from being imported yellow for values which will be auto corrected on import and red for illegal values which will be imported as is Selecting the AutoCorrect check box reveals how the yellow fields will be corrected As illustrated in the example below the Initials sha change to SHA because this field was defined with upper case mapping and Age 59 5 is truncated to 59 because this field was defined as a number with no decimal places Corrections can be
63. a from CRF images received by fax Reports used to run and review study reports List used to review and export data records in tabular and SAS formats Status used to review data query and reason status by work flow levels An overview if the iDataFax views makes up the rest of this tour For more details see the chapter devoted to each view 2 3 Data View The Data View is the primary iDataFax view and is the only view in which patient data queries and reasons can be entered and modified iDataFax User Guide 5 iDataFax File Edit View Show Patient Assessment Page Field Hel a 9 p 808 iDataFax jack Demo Study 1002 3 of 18 Queries se Reasons ia PEEL ETL ITLL lili aagrdddddddd ee She k General OSD DataFax 4253 Plate 4003 Visit 4001 H1001 v H1002 Patient Patient WO Screening Visits Number 02002 Initials FML i7 1 Blood Pressure Screening 1 Baseline VY 2 Patient Entry Form v x MEDICAL HISTORY 4 Current Medications Currently on Resolved 21 1 Month Follow up Duration Treatment and or Controlled gt E22 2 Month Follow up amp Months No Yes vo Yes gt 23 3 Month Follow up 1 Hypertension 06 gt C gt G gt O Se O gt O H1003 W 1004 100s rdial infarction Query Problem Other Details Does the patient have any limitations or problems related to this Diabetes value defect Reply jack May 11 2006 5 42 18 PM No
64. a view Show and Query are the only menus containing options specific to the Queries view 5 3 1 The Show Menu The Show menu is used to select the queries to be displayed in the queries table The following options are available All Queries show all queries Outstanding Queries show queries that still need to be addressed Resolved Queries show queries that have been resolved Pending Queries show queries that are awaiting central office review Overdue Visit Queries show outstanding queries for assessments that are overdue Missing Page Queries show outstanding queries for pages that need to be completed Data Correction Queries show outstanding queries that request data corrections Data Clarification Queries show outstanding queries that require a detailed reply Outstanding Queries Created in the Past show outstanding queries added in the past 5 10 15 20 25 or 30 days Outstanding Queries Created More Than show outstanding queries that are older than 5 10 15 20 25 or 30 days Search Queries displays a dialog used to search for queries with specified properties as illustrated below 72 5 3 2 The Query Menu Tobe selected a query must match all of Show Search Queries criteria speci fied in this enor iDataFax Search Queries gt dialog and the user must have Search Direction permission to l Sup view it Criteria Patient ID i Down left empty are Assessment irrelevant to the Pa
65. aFax follows this patient binder analogy When you open a clinical site like walking into your office you will see a list of patient icons like patient binders on a shelf Double clicking a patient icon opens the binder to reveal the list of assessments that comprise all patient visits from beginning to end of the study Double clicking an assessment opens that section of the binder to show the data collection pages for that assessment When you are finished reviewing or entering data double clicking an open assessment or patient binder will close it Each assessment and page within an assessment has a text label describing what it is and colored icons that identify whether it is required or optional blank or containing data and if data is present whether it is complete or incomplete 1 10 Can use iDataFax for more than one study at a time In addition to the data view there is a queries view that lets you review data queries from the central office and jump to each relevant data field where you can enter a reply or correct the data value This familiar organization along with the use of icons and color makes navigating the study forms as easy as using a printed patient binder perhaps even easier 1 10 Can use iDataFax for more than one study at a time Yes The login screen asks you to specify the name of the DataFax server at the study coordinating center Once you connect to the desired server you will see a list of all the
66. al Resolved corrected __1 Pending _ Weight in Ibs 3 Approved Height in in 3 Approved Value 25 10 42 Query Problem Inconsistent B Type Clarification Ep Use External B Details Age 55 on Form 1 does not match age 58 calculated from date of birth 25 10 42 on Form 2 Note 0C2 1 jack December 13 2007 20 52 00 Reply Status gt Resolved corrected jack December 13 2007 21 04 24 v l gt 3 Reason Age was entered incorrectly on the screening form this has been corrected jack December 13 2007 20 54 56 Status Pending v 1 gt 3 Previous o Next x 4 14 Transmitting Scanned CRFs Date of Birth has a query and a reason and a current value of 25 10 42 The query generated by an edit check was accepted by user jack on December 13 2007 Jack corrected a data entry error for age on the screening form and explained this in a reason He then returned to the Date of Birth field where the edit check found the problem now fixed and thus resolved the query The reviewer should change Reason status from Pending to Accepted and save it by clicking the button below Reason status When this is done the reason level and status will be updated in the list at the top of the dialog Saves in this dialog are immediate but only effect queries and reasons without chang ing the level of the asso ciated data record The Revert button can be used to undo changes to data and metadata
67. allowed to create new queries and determines the default usage type set in the query creation dialog External queries are directed to the clinical sites while internal queries are not Type clarification or correction this preference is only relevant to users who are allowed to create new queries and determines the default response type set in the query creation dialog Clarification queries are used to request a reply to a question while correction queries are used to request a correction to one or more data fields 12 5 List View show field name generic or unique and number name this preference is used to specify column labels for the list view data table These labels can display the generic or unique field name and may also include the field s data entry tab order number show coded field code or label this preference determines whether fields that have codes and labels e g 1 male 2 female display the code or the label show date field default calendar julian and apply imputation dates may be shown exactly as entered into the study database defaut in calendar format with 4 digit years or as a julian number In addition any imputation rules that have been specified for partial dates may be applied if the calen dar or julian format is selected show field color coding each cell in the data table may be displayed in the same color used in Data View red field is illegal or blank but required etc see Help Color
68. and Visit as needed and click the Identify button If the plate is defined as having the visit number in the bar code it must be entered before clicking Identify an error message will appear if you fail to do this Alternatively when the visit number is the first data field on the plate the Visit key should be left blank but will be silently ignored if you enter one A Right Click will abort the Rotate Shift Identify action Once the Identify button is selected the action is committed and cannot be undone The page will then be sent for ICR processing and routed to the desig nated study database There will be a brief pause while this is being done Then the page will disappear and the next unidentified page will be displayed if there is one 11 7 2 Move Select Move from the Action menu to move a page to a specified file name somewhere on you local PC This will display your standard file system navigation dialog used for selecting folders and files Moved files are removed from the DataFax server and stored in PNG format on the the users local computer 11 7 3 Discard To discard an image select the image to discard in the page list then select Discard A confirmation dialog will then appear and if you click Yes to discard the image it will be permanentaly deleted from the study server This can not be undone You can discard multiple pages by selecting more than one page from the page list before selecting Discard 123
69. ange Mode amp Level to set mode to Validate and Level to 2 Next use Select Search to find the QC report pages that are currently at level 1 Then after reviewing each page save it by selecting Final or Incomplete This will move the page to level 2 You can use the search dialog again at any time to find the pages that currently have incomplete status 8 13 List View Menus This section describes the List view options available under the Select and Show menus which appear at the top of the screen The options available under the remaining menus have already been described for the Data view 8 13 1 The Select Menu The Select menu is used to select the data records rows and data fields columns to be displayed in the List view table The options include e All Records cancel current task set if any and show all data records for the CRF page currently selected in the left panel of the List view dialog When cancelling a task set a new mode and sign off level can be specified in a pop up dialog e Field Selection select and arrange the data fields page to be displayed from the current page e Search specify criteria used to find data records reduce the rows in the List view table to those meeting the specified criteria and or to create a new task set e By View select data records rows and data fields columns using a pre defined view e Cancel View cancel previous By View selection to display all data
70. any value will resolve a query with problem type Missing but not a query with problem type Illegal In addition to the above auto reolution rules edit check programmers can resolve queries when certain conditions are met using the edit check function dfeditqc In this case there are no restrictions on the type of queries that can be resolved other than those imposed by the edit check programmer 4 13 Review Approve Queries and Reasons Central office review and approval of reasons and query replies can be performed using Field Review Queries and Reasons or Field Approve Queries and Reasons which produce the dialog illustrated below The dialog looks the same for these 2 option but they differ in behavior The Review dialog shown below lists all queries and reasons on the current page while the Approve dialog lists only those queries and reasons with status Pending Also when a query or reason is changed from status pending to approved or rejected it is removed from the Approve dialog but remains visible in the Review dialog To use this feature start by retrieving the records to be reviewed and if necessary set the working mode and level per your study workflow SOPs Using these dialogs in Validate mode is generally the best choice as it allows you to save the data records to also move them to the sign off work flow level Next select the Review or Approve dialog and position it beside the data window Then as
71. ar the user might enter their best guess in the data window but change the query to indicate that the year was unclear like this Jan 2009 e Problem The problem type can be one of missing illegal inconsistent illegible fax noise and other e Use Use can be external meaning the query is to be directed to the clinical site or internal indicat ing it is for the data management center only e Status The status of each query is updated as appropriate to one of the following o New the query addresses a new problem which has not yet been transmitted to the clinical site Revised the query addresses a revised problem which has not yet been transmitted to the clini cal site O Outstanding the query has been transmitted to the clinical site but has not yet been resolved Pending the site has responded to the query but the reply has not yet been reviewed by the data management office o Resolved NA the query has been resolved the requested data or correction is Not Available Resolved irrelevant the query has been resolved the query was deemed to have been unnec essary 57 iDataFax User Guide o Resolved corrected the query has been resolved the requested correction or information has been received e Type Type will be Correction if the query asks for some data correction or Clarification if the query requests additional information e Details A description of the problem and the request
72. arious ways to find the ones you are interested in For example by selecting Show Outstanding Queries you can list just those queries that need to be answered Double clicking a query opens the data view to the relevant page and puts focus on the data field with the query 2 5 Reasons View The Reasons View lists any reasons that have been entered to explain particular data fields 12 iDataFax File View Show Reason Help 2 6 Fax View e098 Data iDataFax jack Demo Study Queries Site 1 reasons 1 rejected and 2 pending Site Patient Field Reason Site 1 General Hospital 1001 Screening Visits Blood Pressure Screening Screen 2 Date Did not return for the second screening visit 1002 Baseline Medical History 1 Hypertension Duratn Yrs Patient says he had his blood pressure under control until about 6 months ago when he became dissatisfied with side effects from his antihypertensive meds v 1002 Baseline Medical History 4 Valvular HD Duratn Yrs Patient has a congenital mitral valve defect surgically corrected at age 6 x 1002 1 Month Follow up Monthly Follow up Reading 1 systolic BP Not done 1002 1 Month Follow up Monthly Follow up Weight in kg Patient refused to be weighed Status Pending review jack May 11 2006 12 51 54 AM Approved dwt May 11 2006 2 27 31 PM Approved dwt May 9 2006 11 18 46 AM Rejected dwt May 16 2006 5 29 30 PM Pending review jack May 13 20
73. ata View with the focus on the field to which the query is attached This makes it easy to locate the field that needs to be corrected or to enter a reply to the query or a reason explaining the data data value When you are finished with the data field in Data View the quickest way to return to Queries View is to use the Return to Query View button located at the bottom of the record navigation list on the left side of the screen 5 2 Query Status Query status has one of 3 possible values e Outstanding the query still needs to be addressed e Pending the query has been addressed and is waiting for someone at the study coordinating center to review it e Resolved the problem has been solved This may occur automatically as when a legal value is entered into a field that has a query of problem type missing or illegal Or a query may be resolved by someone at the study coordinating center Query resolutions are classified in one of 3 ways resolved corrected always the desired solution 71 iDataFax User Guide resolved NA the requested data information is just not available resolved irrelevant it was an unnecessary query to begin with 5 3 Queries View Menus This section describes the options available under the menu labels File View Show Query and Help which appear at the top of the screen The File View and Help menus are the same across all views and have already been described above for the Dat
74. atment is the patient on 1002 Baseline Medical History 4 Valvular HD Duratn Yrs 45 Other Pending review Does the patient have any limitations or problems related to Reply jack May 11 2006 5 42 18 PM __ this value defect _ No ee v 1003 Baseline Current Medications 1 Drug Name Missing Resolved corrected dwt May 16 2006 5 17 22 PM The Queries View is used to review questions from the study coordinating center 5 1 The Queries Table As illustrated above each query is identified by the patient ID number assessment and page on which it occurs Under the heading Field Problem the data field is identified along with it s current value and the problem type in brackets If necessary this may be followed by a description of the problem or a ques tion from the study coordinating center The last column shows the current status of each query when status was set and by whom and the current reply made to the query if any Each query is marked with a symbol that shows its current status a green check mark for resolved queries a red x for queries that are outstanding and a yellow dash for pending queries i e where someone has responded to the query but the response has not yet been reviewed by the study coordinat ing center When a query is selected a bounding box is displayed around it as illustrated above for the 3rd query in the table Double clicking on a query closes Query View and opens D
75. atus and Final can not be used if the page still has problem fields If you can not locate the problem fields select Page gt List All Outstanding Problems on This Page and a dialog will appear listing the problems that are preventing you from saving the page with status Final After you save a page the next page that is open in the patient binder list if any will be opened in the data window with the focus on the first field at the top of the page Continue in this way to complete all pages in the assessment s you have opened Note that those assessments and pages with a square icon are required while those with a circle icon are optional i e not required for all patients However an optional page may become required if some specified condition is met thus you may find a missing page query on what appears to be an optional page Examine the icons for each page you have completed to confirm that you have saved them with the correct status Those with a green check mark have been assigned Final status those with a red X are Incomplete those with a yellow dash have been marked Pending and any page with an empty 21 iDataFax User Guide icon has not yet been completed 17 When you are finished with a patient binder double clicking the head icon will close it The current binder will also close if you decide to open a different one Remember that only one patient binder can be open at a time and while you have it op
76. be changed Simply select the check box beside each page you want to import or click the Select All button to select all pages Then click the Import button A dialog will appear asking you to re enter your password You can still Cancel at this point If you proceed and enter your password the selected pages will be imported after which a results dialog will appear displaying a summary of the transaction including a list of the pages that were imported If the current data record had one or more images before import all imported pages become secondary images otherwise the first imported page becomes the primary image and the rest become secondary The imported images can be reviewed and the primary secondary classification can be changed using the Review Images dialog which is selected by clicking on the image count button at the bottom of the screen or by selecting Review Images from the Page menu Attach each page to the data record identified below Use this option if the PDF contains pages that belong to a number of different data records To use this option you must be able to identify the data record that is to receive each page by entering its keys Patient Plate Page and Visit Assessment in the spreadsheet If any of the imported pages are bar coded to identify where they belong in the patient binders values for Plate Page and Visit Assessment will be read from the bar codes otherwise enter the appropriate nu
77. binder to the current site for a specified patient ID number Only patient ID numbers which have been predefined as belonging to the current site are accepted Expand All Assessments opens all assessments in the current patient binder Collapse All Assessments closes all assessments in the current patient binder 4 16 6 Assessment Menu When an assessment is selected in the patient binder window the following options are available Add New Assessment some optional patient assessments may be listed in the patient binder while others may be selected from this menu and added to the current patient binder Mark Assessment Lost if an entire patient assessment is unavailable e g because the patient missed the visit this option can be used to mark it lost If a special missed visit report page has been created for the study it will appear and must be completed and saved like any other study page If a missed visit report page has not be created for the study a default dialog will appear In this dialog you must select a reason from the choice list Additional text can be entered to explain why the assessment will not be completed All required pages in the assessment will then be marked Lost a L icon will appear on each of these pages in the record list data entry will be blocked on all of these pages and the reason will then be displayed in the reason window bottom left corner of the iDataFax window whenever one of these pages is
78. cases the first unused binder in this list will be H H the correct binder for the next patient Double clicking the binder will open it If the patient ID number you need is not in the patient binder list select Patient gt Start New Patient and enter the patient ID number as shown in this example When you select OK a new patient binder will be added to the list with the specified patient ID and the binder will open automatically Patient Start New Patient O iDataFax Start New Patient Please indicate patient ID for site 1 Patient ID 1015 Confirm 1015 B Note If instead of a new patient ID you enter one that already exists in the Cancel patient binder list that binder will open when you click OK If the binder is already in use the head icon and one or more of the assessment icons will be active not muted and empty iDataFax User Guide 3 2 Can print a copy of a patient binder Yes You may need blank copies of the data forms to use as worksheets before entering the data in iDataFax or because you complete and fax certain pages so that staff at the study coordinating center can enter the data for you Or you might want to print a completed assessment so it can be added to the patient s medical records You have 2 options with very similar dialogs File gt Print shown below and File gt Save As PDF File Print To print patient CRFs iDataFax Page Setup 1 Select View gt Data to ope
79. ch week Select Define Report List iDataFax Define Report List List Name Weekly QC Reports Description check database then create amp send QC reports R o y se oi Give each report list a DP_ICvisitmap DF_XXkeys DP ItCkeys DF_ICqes DF ICcyvisitdates DP_QCupdate j DF _OCreports csPQ p 3 e X 1 lastv s yes iy User Roles Admin Logins jack jill Owner Roles Logins dwt Created dwt November 21 2008 16 20 12 Modified dwt November 21 2008 16 38 21 Sav Done Clear Cancel 4 if eer name and one line description Remeber to include the desired options for each report Users must have permission to run each report in the list Owners will be able to modify the report list To access a previously defined report list use Select Report List to invoke the dialog illustrated below and select the desired report list 112 9 6 Saving Report Lists Select Report List iDataFax Select Report List Center Tracking for weekly steering comittee meetings This example has 2 report lists Weekiy QC Reports check database then create amp send OC reports The first one has been selected The 3 reports it contains are displayed with their options Report Options DF_CTcrfs i r R t 08 01 01 all reports has been selected OF CE thus the reports will be run in Tacs order when OK is selected The output will be added to the current Run selected repo
80. chnology used by banks and other secure applications 1 5 What kind of response time can I expect As with all internet applications this depends primarily on the speed and traffic on your internet connec tion and to a lesser extent on the distance between you and the study DataFax server If you have a cable or DSL internet connection you can expect login times in the range of 5 to 20 seconds and then 1 to 4 seconds to display each new page in the data entry window Once a page is on the screen moving between data fields is very fast with essentially no delay iDataFax User Guide 1 6 How complicated is this going to be With a little practice you should find that completing data collection pages in iDataFax is just as easy as completing a printed version of the same page In addition the guidance provided by color coding e g illegal values appear red and the messages displayed by data consistency checks will help you identify problems which can be corrected immediately or explained by entering a reason for unusual values This advantage over paper forms will help you avoid queries and requests for corrections from the study coordi nating center thus saving you time in the long run 1 7 ls any patient data stored on my local hard drive No all patient data is sent to and retrieved from the DataFax server at the study coordinating center As a result you can access the study from any computer on which iDataFax has been instal
81. complete and or Pending pages iDataFax File Edit View Show Patient Assessment Page Field Help r e208 All Patients tudy Potential Patients Enrolled Patients Complete to Date Patients v Incomplete to Date Patients N Site 1 General Hospital 1002 P 1005 If no patient binders appear in the list congratulations you have no outstanding problems Otherwise for each patient binder proceed as follows 29 iDataFax User Guide 1 When you open a patient binder scan the list of assessments for those which are Incomplete red X or Pending yellow dash 2 When you open one of these assessments the Incomplete and Pending pages will be identified with the same red and yellow icons 3 When you select one of these pages look for the red and blue fields The blue fields have metadata either an unresolved query or a rejected reason The red fields contain illegal values or are required but currently blank 4 It is possible to save a page with Incomplete status even though it has no red or blue fields This might be done when there are optional fields that still need to be completed Users may have flagged these fields with reasons thus it would also be a good idea to review any orange fields 5 If you are able to solve all problems on a page save your changes using status Final This will flag the page with a green check mark indicating that it is done g iDataFax File Edit View Show Patient Assessmen
82. ction on defining tasks As for predefined task sets the records in an adhoc task set are also flagged with the T and t icons To get started choose Select By Data Fields to launch the dialog shown below To be selected a record must meet all of the speci Select By Data Fields fied criteria Criteria that are left blank are irrelevant In this example Pages 8 and 9 that are at work flow Level 1 with status Final will be selected for all iDataFax Select by Data Fields Mode Validate Sign off Level 2 E M Enable edit checks patients at Sites 1 to 33 Search Data J Queries _ Reasons By program The selected records will Status __ Final Incomplete Pending Lost be reviewed in Validate Site 1 33 mode with a sign off level Patient ID of 2 Thus whether or not a record is modified it will Assessment be raised to level 2 if it is Page 8 9 saved using one of the Level 1 Save buttons at the bottom of the screen Creation Modification If you select Build Set the Pattern dialog will remain open and you will be able to add Expression more records to the adhoc task set by specifying a new set of criteria and again selecting the Build Set button tuild See ae aaa na Select Done when you are finished building your task set and are ready to review the records Searching by Data Queries or Reasons determines whether the search criteria are applied to data records query records or reason
83. d before the DF_QCupdate program is scheduled to run While this chapter refers to the processing of unidentified pages received by fax the same procedures apply to unidentified pages received by email as pdf or tif attachments or submitted using DFinnotify rpc after being scanned 11 2 Router Functions The router is used to Review all unidentified pages Get context determine when the fax arrived and where it came from Delete pages that are not needed e g fax cover sheets blank pages Print non CRF pages or save them to a PDF file Fix any fax transmission problems e g flip rotate truncate cut Identify CRFs and other patient documents and send them to the correct study database OaRWND 11 3 Restrictions Three factors determine what a user can do in the router Router Permission Users with router permission can start the router and view print delete and check the context of all unidentified pages that arrive on the DataFax server They can also identify and send pages to any study on the server even if they have no other study permissions with the following qualifi cations 117 iDataFax User Guide Study Status DataFax and study administrators can place temporary or permanent restrictions on a study by changing it s status to disabled read only restricted for administrators only or both restricted and read only Pages cannot be sent to studies that are disabled or in read
84. d date for the current task set e Print print blank CRF books with patient ID and visit numbers pre printed or pages containing data and or images from the current patient binder or task set e Print Task Set print the data record keys set creation method set instructions user name and date for the current task set e Preferences this dialog is used to set user preferences Changes are applied immediately and persist the next time you login e Change Password allows you to change your iDataFax login password e New Study allows you to return to the login study selection dialog and either lauch a new study session on the current server or launch a new login session This may be useful if you want to compare data in 2 different studies compare information presented in different views e g reports and data views within the same study or compare behavior for 2 login sessions with different study roles during study setup e Close Study closes your connection to the current study and returns to the study selection window where a different study may be selected from among those available on the current iDataFax server e Exit closes your connection to both the current study and the current iDataFax server and termi nates the iDataFax program 66 4 16 2 Edit Menu 4 16 2 Edit Menu When a field in the data entry window is selected the following Edit menu items become available Undo Undoes the last
85. d faxes 1 DF_SSvisitmap b DF_ATmods Trace database modifications over a time period DF_WFerfs lt g DE WFrrfsnarwk ba a ae jarel 110 9 2 Report Types 9 2 Report Types The button above the list of reports has 3 options 1 DataFax Reports Selecting this option will list all of the standard DataFax reports for which you have permission The standard reports are designed to address common trial management needs like summarizing data management status for individual patients and clinical centers 2 Study Reports Selecting this option will list the study specific reports designed by programming staff at the trial coordinating center to address needs not covered by any of the standard DataFax reports 3 History Each report you run is added to the History list You can review the output from any report by opening this list and selecting the report If you run a large number of reports or the output from some of your reports is very long you may exhaust the memory cache used to save the output from each report If this occurs you will not see any output on selecting some of the older reports from the history list But you can re run reports from within the history list by selecting Run The report will then run with the same options used the first time unless you change them and will itself be added to the end of the history list 9 3 Explain Report Documentation All DataFax reports and most Study reports will include docu
86. d on October 22 2010 21 52 52 by jack idemo4 datafax com Prom Pile Users jack tmp ScreeningData_150910 dat To Plate 001 Blood Pressure Screening Visits Mode Merge Queries resovle missing illegal create missing illegal value queries Reasons add to all changed fields Task Set all imported records 10 Results 0 valid records 0 imported End of Import October 22 2010 21 52 54 ox Corin Save The dialog illustrated above appears when the import is complete with a summary of the import spec ifications and results If any records are rejected e g because you selected Mode New but some input records already existed in the study database they will be displayed in this dialog along with the reason they were rejected Also a Save Rejected Records button will appear so that these records can be saved to disc This allows you to deal with the problem s that blocked import and try again We recommend keeping a record of all data imports by printing or saving this report While the audit trail will show any new records and data changes made during import by date time and the user who performed the import it does not distinguish between data entered and saved in Data View and records that were imported in List View Input data records may be rejected for the following reasons 8 and Lost Records the database record is currently locked by another user Mode Replace but the record does not exist
87. data and metadata remains unchanged Modify in this mode the work flow level is changed to the specified sign off level but only for those data and metadata records that are modified Validate in this mode the work flow level of data and metadata records is changed to the speci fied sign off level when the user selects one of the Save buttons Final Incomplete or Pending regardless of whether or not any changes were made to data or metadata Batch Validate This option can be used to move a set of selected records to a specified work flow level 4 16 4 Show Menu The Show menu is used to determine which patients and data records are listed in the study binder window The following choices are available All Records Show all data records both those included and not included in the current task set Task Records Show only data records that have been assembled in a predefined or adhoc task using the Select menu options All Patients Show all patient binders Potential Patients Show only empty patient binders Enrolled Patients Show only patient binders that contain data Complete to Date Patients Show only patient binders with complete data for all assessments completed to date Incomplete to Date Patients Show only patient binders containing pages marked Incomplete or Pending 67 iDataFax User Guide 4 16 5 Patient Menu The Patient menu includes the following options Start New Patient adds a new patient
88. e This patient slipped on the ice while shovelling te tha event related to a previous adverse event i Initially it appeared to be a simple case of must Deseripon and he has been off work now for 6 weeks Bad fall on ice while shoveling snow Pc Patient was sent for X Rays on Feb 18 2009 able to return to work a 3 z Additional tests on May 14 2009 revealed spine ej SF b gt h C iit A lt gt Split Left Right re Apply Cancel This dialog shows all images linked to the current data record It shows each Image ID when the image was received whether it is the primary top or a secondary image and the Sender ID from the DataFax server fax log This dialog can be used to Review Images Select each image in turn from the image list to display that image e Compare Images The Split button has 3 modes No Top Bottom and Left Right When the window is split click on any 2 images in the image list to display them together Double clicking on one of the images in the image list can then be used to switch them between the 2 display windows e Specify the Primary Image When the dialog opens the primary image is tagged with an asterisk in the image list Selecting a secondary image and then clicking the Primary button will change that image to primary and demote the original primary image to secondary but the asterisk remains on the origi nal primary image as a reminder of which image was primary when you opened the dialo
89. e e Show Field Properties this option lists all properties defined on the current data field including name description style need type format legal values edit checks etc e List History of All Changes on This Field runs the DataFax audit trail report DF_ATmods and displays the results in a separate window The report includes all changes made to the data field which currently has the focus 4 16 9 Help Menu The Help menu launches the help viewer application and displays information about iDataFax It includes Topics launches the online user guide Color Coding displays a summary of the colors used and their meaning Task Instructions displays the instructions for the current task if any Show Roles lists the role s the user plays in the current study About iDataFax displays version and copyright information 70 Chapter 5 The Queries View Chapter 5 The Queries View iDataFax File View Show Query Help Kaka Data iDataFax jack Demo Study as 3 lt Site Patient Reasons je Field Problem Status amp Replies Site 1 General Hospital TO x 1002 Baseline Medical History 2 Atrial Fib Ouratn Mon 18 Illegal Outstanding dwt May 11 2006 2 31 51 PM Please change to 01 years and 06 months and complete all durations in this way Thank you x 1002 Baseline Medical History 2 Atrial Fib Treatment Yes Other Outstanding dwt May 11 2006 2 34 07 PM What type of tre
90. e or replace existing data records Queries M Resolve missing value queries when a legal value is imported M Resolve illegal value queries when a legal value is imported Create missing value query when blank is imported to a required essential field wv Create illegal value query when an illegal value is imported W Add Reasons to database fields that are changed by imported replacement records Add Pending reasons _ Add Approved reasons for records with Approve Reason permission otherwise add Pending reasons i Task Set Create a new task set containing all imported records _ Create a new task set containing imported records with illegal missing values Mode Modify eA Sign Off Level 1 r v Enable edit checks Back Review data Next Import data If from the Next Save data button you select Save Records to Local Data File you will simply see a file selection dialog but if you select Save Records to DataFax Database you will be presented with the dialog illustrated above Select Mode New if all input records have keys ID visit plate that do not already exist in the study database When using this mode only new records will be imported any replacement records will be rejected Select Mode Replace if all input records have keys ID visit plate that already exist in the study database When using this mode only replacement records will be imported any new records will be rejected
91. e the edit check might be programmed to provide the lookup table to only specified users users with specified roles or users performing a specified task and the lookup table might always appear on entry to some data field or only when an exact match can not be found automatically Regardless of how the edit check is programmed if a lookup table appears while performing data entry the user is able to search the lookup table and select one of it s entries rows or click the Cancel button to select none of them The following example shows a lookup table which has been created for MedDRA coding The division of each row into fields the field labels the order in which they appear which fields are shown in the dialog and which fields are returned to the edit check when a row is selected are all customizable by the edit check programmer 54 4 10 Using Lookup Tables Lookup Table Example 1 iDataFax DFlookup MedDRA Search Terms fatigue find entries with ANY ALL of the search terms in the following fields Lookup Fields Current Selection V Low Level Term Tiredness Preferred Term Fatigue _ High Level Term Asthenic conditions _ High Level Group Term General system disorders NEC System Organ Class General disorders and administration site conditions _ Low Level Code 10043890 Find Previous Filter 41 matches Reset LL TERM PREFERRED HL TERM HLG TERM SOC TERM LL CODE Exhaustion Fatigue Asthenic condit Ce
92. e Green fields with approved metadata a resolved query an accepted reason or a predefined missing value code If more than one color might apply descending priority order is blue orange and then green 4 4 Entering Data and Metadata Entering data is very similar to completing paper forms with a computer mouse and keyboard replacing pen and ink You can go to any field by selecting it with the mouse move to the next field using the Tab or Return keys or move back to the previous field using Shift Tab or Shift Return The current field will be highlighted in the data window If legal values or other help text has been defined for the current field it will appear in the bottom right corner of the iDataFax window 35 iDataFax User Guide All entry of data values and metadata query replies reasons and missing values apply to the current field So make sure the correct field is highlighted in the Data window before entering data and metadata Choice fields which allow you to select one of the listed response options are displayed with a small circle beside each option The circle is filled in for the current option if any You can select a response option by clicking on the circle with the mouse or by using the number keys 1 for the first option 2 for the next etc The current option can be removed returning the field to blank using the Delete key String fields are limited to the printable 7 bit ASCII character set a
93. e and value of any reasons and queries associated with the field Add Reason for Data Value used to explain the current data value The reason dialog can also be invoked by pressing the button on the Reason metadata window in the bottom left corner of the screen Delete Reason for Data Value used to delete the reason on the current data field note permission to use this option is typically tightly controlled Reply to Query used to reply to an unresolved query on the current field The reply dialog can also be launched by selecting the button on the Query metadata window in the bottom left corner of the screen Some queries can be resolved by correcting the data field and do not require a direct reply If the study coordinating center wants a direct reply to the query the phrase reply required will appear at the top of the Query metadata window Add Query used by the study coordinating center to add a query to the current data field Edit Query used by the study coordinating center to modify a query on the current data field Delete Query used by the study coordinating center to remove a query from the current data field Approve Queries and Reasons used by the study coordinating center to approve or reject pending reasons and query replies on the current page Review Queries and Reasons used by the study coordinating center to review all reasons and 69 iDataFax User Guide queries resolved and unresolved on the current pag
94. e because the assessment is made up of different exams and some are not relevant for some reason or because the patient refused to complete the entire exam Whatever the reason individual pages can be marked lost Page Mark Page Lost To mark a page lost ane iDataFax Lost Page 1 Select View gt Data to open the data view Site 1 Patient 1002 Assessment Patient Diary Week 01 2 Double click the patient binder to open it and Page Weekly Patient Diary display the study assessments ae a 3 Double click the assessment to open it r 4 Click the page you want to mark lost It will Details patient did not keep the diary for the first week but appear in the data window E E RE eee mea 5 Select Page gt Mark Page Lost This opens the dialog shown here where you can select the reason category and enter details describing the Mark Page Lost Cancel circumstances 6 When you click Mark Page Lost the lost symbol L will appear in the page icon 3 13 Do I need to save the changes have made Save Buttons Save Final incomplete Pending Last Save May 11 2006 4 50 14 PM Yes None of the changes you make to data fields or metadata queries reasons and missing values will be saved until you select one of the save buttons at the bottom of the data window If you try to close the current page or open a different page without saving changes a dialog will appear asking if you want to save or discard your changes bef
95. e contains 13 pages O in use Since plates 1 5 were specified only Sign off Level 1 15 MM Enable Edit Checks these plates were listed when the Get List button was selected Plates 1 5 Visits gt If ICR was able to read the key fields l ID Visit and Plate they will appear Sort Oldest to Newest Newest to Oldest beside each fax page name Get List C Select all_ Deselect All Clear yyww tfffppp where yy year wwe week ffff fax ppp page a arate Records can be selected individually A 0909 0004001 04008 A s se 2 E using a mouse click to select one 0909 0004002 04002 1 2 record and Shift click to select all V 0909 0004003 05001 1 3 records between the last selection i 0909 0004004 4 and the Shift click record or all MM 0909 0004005 05001 21 5 E be a using A 0909 0004006 05001 22 5 PORTAN as DOWNS Vi 0909 0004008 05001 24 5 Finally to assemble the selected ii 0909 0004013 23 5 records click OK OK 8 8selected Cancel Automatic Retrieval allows users to get a specified number of faxes pages or plates at a time and repeat this process as desired by clicking the Get Next Set of New Records button at the bottom of the record list This avoids having to return to the record selection dialog after each set of faxed pages have been entered Select Automatic Retrieval e 66 iDataFax Record Retrieval The current status of the new record queue is updated and dis
96. e necessary permissions Changing any or all of the other 3 keys Patient page assessment and patient will move the data record to another patient Change from 16002 to binder or another location in the current nema patient binder All queries reasons and images will move with the data record A reason may be specified to explain the change This is optional but recom mended OK E Cancel If OK is selected to confirm the change iDataFax checks to see if the new plate is compatible with the old one and also checks to see if a data record with the new keys already exists in the database You will then be presented with one of the following 4 confirmation dialogs depending on the result of these 2 checks 297 iDataFax User Guide No existing record but pages are incompatible jooo You are about to chang l the page from 003 to 002 iDataFax Change Keys Warning Page 003 and 002 are not compatible All data queries and reasons on this page will be discarded To save these changes select Final Incomplete or Pending To open this page with it s new keys check the box below v Remain on this page when it is saved Save Final Discard Changes SS No existing record and pages are compatible Pending 890909 iDataFax Change Keys You are about to change i the patient from 3002 to 3003 M Remain on this page when it is saved Discard Changes To save these changes select Final
97. e pages by rotating them into portrait orientation and scaling them to fit the width of a portrait page This is achieved using Rotate 90 CW and scale or Rotate 90 CCW and scale Select the appropriate menu item to apply the needed rotation The page will be rotated and then scaled automatically to fit the width of a portrait US letter page 11 6 9 Print To print one or more pages select the page or pages you want to print in the page list then select Print from the Page menu to get the standard Print dialog box for your PC 11 6 10 Export as PDF To export one or more pages in a PDF file select the page or pages you want to print in the page list then select Export as PDF from the Page menu to get the standard file save dialog and specify the file name you wish to use 121 iDataFax User Guide 11 6 11 Previous This function moves you to the previous page in the router window 11 6 12 Next This function moves you to the next page in the router window 11 6 13 Context This function can help you determine where an unidentified page came from It provides the page number within the fax the date and time on which the fax was received and the G3 sender identification header from the fax which is usually the sender s fax number Figure 11 2 The Context window e080 Record Context This is page 1 of a 2 page fax received on Mon Nov 20 13 33 08 2006 e from sender id sam datafax com If the sender id
98. e reviewed in List View 116 Chapter 11 Unidentified Fax Router Chapter 11 Unidentified Fax Router 11 1 Introduction When DataFax receives pages which it cannot recognize it stores them in a special folder where they can be reviewed using the iDataFax router Pages need to be routed only if DataFax is unable to find or read the DataFax bar code at the top of the page This occurs when there is no bar code e g memos letters cover pages or when the bar code is obscured e g by fax noise a coffee stain something printed over it Without a readable bar code DataFax can not identify the study Thus all unidentified pages are stored in the same unidentified page folder If you are running several studies the individuals who review and iden tify pages using the router must be sufficiently familiar with all studies to correctly route each page Study CRFs are not difficult to identify correctly unless the bar code is missing altogether In such cases the contents and design of the CRF may be enough to correctly identify it If not selecting Context from the Page menu can be used to determine where the page came from Also remember that DataFax creates missing plate and over due visit queries for required CRFs and visits that have not arrived as specified in the study visit map Thus queries may be generated for pages that have been transmitted by the sites but are currently stuck in the router unless such pages are identifie
99. earch criteria After entering new criteria click Update to update the counts Search Queries A DataFax Search Search Usage Site 1 4 external 47 Patient ID x internal 0 Type Assessment In this example 47 Page 1 10 102 clarification 0 queries match all of the Field correction 47 specified criteria r Problem say Level ae Z Use Save or Print to Creation By i illegal z 3 output the criteria and Modification 8y inconsistent 0 counts shown in this illegible 0 dialog Resolution By 2 fax noise 0 Expression OFQCNOTE EC QCI other o Click Filter to select Missing page j these 47 queries and Direction eager ane 7 5 remove all others from Up As the current list view Status Down wo new not in report 36 Click New Task to put _ Match case in report not sent 11 the data records with F Filter MA in report sent o B queries into a new New Task Add to Task _ resolved not available 0 task set _ resolved not relevant 0 __ resolved corrected 0 _ pending 0 47 queries matched Filter Save Print Update Reset Done After clicking the Filter button to reduce the list to just those queries that match the search criteria new criteria can be specified to narrow the search further within the previously filtered set Records matching new search criteria can be added to a current task list by clicking the Add to Task button If you
100. eason when you change them In such cases this dialog will appear automati cally when you leave the field You can then either enter a reason or use the Revert to Old button to undo the change Once a reason has been entered the OK button is used to apply it The new reason will then appear in the Reason metadata window When a reason is created by a user who has permission to approve reasons the status is automatically set to approved but the Status button is active and can be used to change the status of the new reason w Note Remember that no changes are saved until you select one of the Save buttons at the bottom of the data screen This applies to both data and metadata queries reasons and missing values 3 5 Can use standard missing value codes Yes DataFax supports missing value codes which may be predefined for each study to provide standard accepted reasons for missing data If missing value codes have been predefined for your study you can assign one of them to the current data field by selecting it from the list displayed when you click the button on the Missing Value metadata window shown below and located in the bottom left corner of the screen or using Field gt Mark Field Missing 23 iDataFax User Guide When a missing value code is selected the field turns green provided the field does not have some other problem which indicates that the field has an approved metadata value Note that the missing value is
101. ec DFNUM P plates E editchecks v levels s statuses I IDs S SEQs P another batch specification which warn OPTIONS DFNUM DataFax study number P Plates plate specification starts each new batch specification E Edit Checks edit check names to be executed on the specified plates v select records by specified validation levels 0 7 s status select records by record status final incomplete pending lost I select records by patient ID numbers S select records by sequence visit assessment numbers which msg qc data determines EC events that trigger creation of a DRF record warn display any warning messages generated by DFbatch u print this usage message and quit NOTES 1 iDataFax uses environment variable DFNUM which is set to the current study number Only specify DFNUM on the command line when running DFmkdrf ec from a shell script or terminal session where DFNUM is not set Each batch specification must begin with the P and E options in that order 3 Use E ALL or E all to include all edit checks on the specified plates he which option determines the conditions under which a DRF record is created dit checks are executed with APPLY none so no changes are made to the database nstead a DRF record is created for the current page if the edit check would do he following with APPLY turned on sg execute a message function dferror dfwarning dfmes
102. ed resolution can be entered manually or if standard queries have been pre defined they can be selected by typing a short acronym or using the Details button to select the query from a lookup table e Note An internal note used only by data management staff can be entered for any internal pupose such as recording special circumstances explaining why or how a query was resolved e Time Stamps The creation time stamp is updated when a query is saved with status New The modification time stamp is updated when a query is saved after modification of any of the fields described above The resolution time stamp is updated when Status is changed to one of the 3 reso lution types e OK Selecting OK saves the query but it is not transmitted to the study database until the data record is saved 4 12 Automatic Resolution of Data Queries Some data queries resolve automatically when the data field is corrected while others do not For autores olution to occur all of the following conditions must be met Query Use External Query Type Correction Query Problem Missing or Illegal The data field does not have a Reason with status Rejected If all of the above criteria are met then 1 if the study setup includes a legal value specification for the data field then entry of one of the speci fied legal values will resolve the query 2 if legal values have not been specified for the data field then entry of
103. eld DFmkdrf ec 253 P 1 499 E ALL which data 136
104. elect O Faxes Pages Plates Visits Plates 9 Visits By Age Oldest C Newest Quantity 10 gt pages nd Repeat C swen Done Clear Cancel Users can not enter records in Fax View for which they do not have permission However it is possible for a user to select a fax image for which ICR failed to read the keys and then on entering the keys to discover that they can not save the record Also if ICR misread the keys a user with limited permissions may be prevented from seeing a page they should see in the list of faxed pages These limitations argue against giving the clinical sites access to Fax View except perhaps for Raw Data Entry only Whether using manual or automatic record retrieval set the Sign off Level to the work flow level at which new records are to be saved Typically level 1 is chosen but it is possible to save new records to any work flow level New data entry is always performed in Validate mode which allows records to be saved even if no changes are made The mode and work flow levels are shown beside the Save buttons at the bottom of the screen For example Save v 0 gt 1 indicates that you are in Validate mode and that data and meta data records will be moved from work flow level 0 to work flow level 1 in the study database when the user selects the Final or Incomplete save buttons New records saved with Pending status to indicate that data entry was not completed are saved to the study database
105. ember 16 2008 16 13 20 S criteria C match case M new task Validate A level 3 ra C enable edit checks _Data Fields Field 9 76 ValueMillegal missing M blank required or equals contains or Query L pending L outstanding L resolved and _ external C internal andcontains or Reason L pending rejected _ approved and contains Data Records Status final f incomplete L pending C lost Site Patient ID Assessment Level 1 2 Creation _ Modification Expression ARM I ______ CB vere 8 8 Exporting Data Records lt gt Note This dialog is only available to users who have List create Views permission and can only be used by one person at a time Once views have been defined users can select a view using menu option Select By Views which will display a dialog showing the pre defined view names and descriptions The current view if any will be cancelled when a new view is selected If no records meet the selection criteria for a selected view a dialog will report that no records were found the view will be cancelled and the spreadsheet will return to it s base state showing all data fields and data records The current view can be cancelled at any time to return to the base state by selecting Cancel View from the Select menu lt Select Cancel View Cancelling the current view does not cancel the current task set if any The spreadsheet will return to the base s
106. en no one else will be able to use it except in view only mode 18 When you are finished entering study data or if you need to pause for more than a few minutes exit from the iDataFax application Do not leave your PC unattended while you are logged in to the study database 3 4 Can enter a reason to explain an unusual value or a value I have changed Yes This is a good way to avoid queries from the study coordinating center Adding a new reason or modifying an existing reason for any problem field red or blue creates a pending reason orange which solves the problem pending review by the study coordinating center Dealing with all problem fields this way will allow you to indicate that you are finished with the page by selecting the Final button when you save your modifications How can you tell if a data field has an associated reason When the focus rests on a data field all meta data queries reasons and missing values for that field are shown in the metadata windows below the patient binder list If the field already has a reason it will be displayed in the Reason for Data Value meta data window illustrated below otherwise this window will be empty The Reason Metadata Window The reason metadata window shows Reason for Data Value h e Reason the reason for the current value in the Reason Patient has a congenital mitral data field valve defect surgically corrected at age 6 e Status when a reason is created
107. ent Illegible Fax noise or Other Details a description of the problem if neces sary Old Reply previous reply to this query if any New Reply a space where the new reply can be entered When the focus moves to a data field which has a query the query is displayed in the Query meta data window If the field does not have a query this window will be empty The Query metadata window contains Problem the problem type Details a description of the problem if any Reply the reply to the query if any Status the current status of the query Created who created the query and when Resolved who resolved the query and when 3 9 Can respond to a query by adding a reason for the data value Yes and often this will be the best response Unless a query indicates that a reply is required adding a reason to explain the data value is the better solution because the reasons you enter will not be changed by the study coordinating center and will thus always be visible in the Reason for Data Value metadata window whereas the current query once resolved may be replaced by a new query to address a new problem a Note As ageneral rule use reasons to explain why data fields have the values they do and only reply directly to queries when it is necessary to refer to other data fields or explain something not contained in the reason 26 3 10 How should respond to a query if the data field is correct as is
108. equently saved by someone else or at different levels or without an associated image DFmkdrf jnl 253 image yes u jack dianne v 1 t 071101 071130 Repeat the above but only create DRF records if the selection critera remain in effect now i e deselect any records that no longer meet the selection criteria at the end of the audit trail DFmkdrf jnl 253 image yes u jack dianne v 1 t 071101 071130 d 2 Create a DRF file named myTest drf for data records in study 253 which were saved in the past 10 days with visit numbers 1 2 or 50 59 and record status incomplete by someone other than the current user DFmkdrf jnl 253 days 10 S 1 2 50 59 s incomplete xu whoami put myTest drf Load DFunexpected drf a DRF file created by DF_QCupdate and stored in the study drf folder DFmkdrf jnl 253 get DFunexpected drf 135 iDataFax User Guide 13 3 2 DFmkdrf ec make DataFax DRF file from edit checks Program DFmkdrf ec creates a DFbatch file and runs it to identify records with edit checks that would display a message create or edit a query or modify a data field were they to be run interactivly No changes are made to data or metadata The only output is a DataFax retrieval file listing the records that met the specified criteria Any given user will only see those records they have permission to get The program usage message follows DFmkdrf ec make DRF records by running DFbatch to execute specified edit checks USAGE DFmkdrf
109. er account Contact the iDataFax Study Coordinator or System Administrator Unable to load assessments Please contact iDataFax system administrator The DataFax DFvisit_map does not exist or is empty or the user may not have permissions to access the necessary visits and or plates due to restrictions defined in their study role Contact the iDataFax Study Coordinator or System Administrator 131 iDataFax User Guide Message Possible Cause Solution Table 13 2 Data Entry Message Possible Cause Solution Message Possible Cause Solution Message It appears that your computer s date and time are incorrect iDataFax has been set to view only mode until the date and time are fixed and you login again Either iDataFax can not obtain a valid date and time from the computer on which it is running or the value obtained is more than 48 hours ahead or behind the value obtained from the study database server Update the date and or time on the computer that is running iDataFax You have been automatically logged out of your current session The user s iDataFax session has been inactive for the number of minutes specified by the user s Auto Logout setting Each user can customize the number of minutes after which the iDataFax auto logout takes effect The default Auto Logout setting may be changed by logging into iDataFax opening the Prefer ences dialog from the File menu and chan
110. ew in the Unidentified Fax Router 3 _ includes pages for all studies Pages awaiting review in the Study New Fax Queue 4 _ inctudes 0 pages in use Site i Update Patient iD eam Assessment e ET Page N A Data Records Queries Reasons Level Pending Lost incomp Final Total Pending Unres Resivd Total Pending Rejetd Aporvd Total 0 5 5 53 53 2 2 4 1 28 19 47 1 51 13 65 3 1 15 19 2 6 5 ll 1 33 14 48 2 11 13 3 1 2 3 2 2 10 10 4 1 2 3 6 23 23 6 6 5 2 2 6 Total 5 1 37 29 72 2 162 29 193 7 1 44 52 5 Graphics by level by status Level 0 Level 0 Levei 0 Level 1 Level 1 Level 1 Level 2 Level 2 Level 2 Level 3 Level 3 Level 3 Level 4 Level 4 Level 4 Level 5 Level 5 Level 5 Level 6 Level 6 Level 6 Level 7 Level 7 Level 7 BPending MfLost Mfincomplete Mrinal Brending Munresolved WResoived BiPending M Rejected Approved Study Users a Host Too Since jack localhost iDataFax 2008 03 05 11 09 dwt localhost iDataFax 2008 03 05 11 13 3 dwt localhost Setup Tool 2008 03 05 11 10 angela localhost iDataFax 2008 03 05 11 12 Last update 3 5 08 11 13 AM I d gt e Permissions The information displayed in Status View depends on user permissions Counts will only be displayed for records that you have permission to see e Filters The record counts can be displayed for specified sites patients assessments and CRF pages by entering the desired values in the filte
111. g Changes in image status do not take effect until the Apply button is selected e Delete Images Selecting an image and then clicking the Delete button will change Status to deleted but this will not take effect until you click Apply Status can be changed from deleted back to primary or secondary by clicking Undelete but once Apply is selected this is no longer possi ble If there is more than one image the primary copy can not be deleted until all secondary images 41 iDataFax User Guide have been deleted e Fix Keys If an image has been linked to the wrong data record you can relink it to the correct record by selecting Fix Keys and then entering the correct patient ID visit and plate numbers The image will then be unlinked from the current data record and linked as a secondary image to the new data record If necessary you can then open the new record to change the image status from secondary to primary 4 8 Working with Tasks Tasks comprised of user instructions and record retrieval specifications can be defined and assigned to individual users or study roles Any user with access to Data View can perform tasks but Data with Select permission is required to define tasks 4 8 1 Performing Tasks To perform a task use the Select By Task menu item to invoke the following dialog Select By Task iDataFax Select by Task DDE double data entry Fax
112. g a fax to the wrong fax number 3 Select Submit PDF from the File menu in Data View 4 This will launch the standard file selection browser on your PC Use it to select the PDF files you want to transmit 5 Next you will see a confirmation dialog identifying the DataFax server and each PDF file you selected for transmission After confirming that these are correct selecting the Transmit button initiates the transmission while selecting Quit aborts the operation 6 You will see a progress bar while each PDF transmission is underway Pressing the Cancel on the progress bar will not stop the current transmission but will cancel transmission of any remaining PDFs 7 When the transmissions are complete the dialog will show the the status of each PDF transmitted failed or canceled The Continue button can then be used to select additional PDFs for transmis sion and the Quit button ends the dialog To use this feature your study role must include permission for iDataFax Data Submit PDF This feature is blocked if a study has been disabled or put into read only mode by a study administrator If a study is in restricted mode PDFs can be submitted by study and DataFax administrators only PDFs transmitted to the server from iDataFax are registered in the DataFax fax log so the Context option can be used to identify when and how they arrived Also just like a fax the transmitted
113. ge Match case search PE Filter i Creation 07 12 01 today By david e Ifthe Filter pakit Ani Rat option is Modification By J selected click Resolution By ing the Find button reduces Usage the query list to external _ internal queries that match the yes search criteria M request for data clarification and the search _ data correction dialog closes E e Otherwise atus z i search direc outstanding _ pending resolved tion up or Problem down is used to find the first missing _ illegal inconsistent match starting illegible a fax noise missing page from the top of EC missing page _ overdue visit _ other the list or from Detail Text the currently selected query eee TERS and the Find Reply Text button changes to Find Next e Searching fora text match in the query note and reply fields Fina Cancel is case insensi tive unless the match case option is selected 5 3 2 The Query Menu This menu has only one option Go To Data Field and is only available after a query has been selected in the Queries table Selecting this option takes you to the Data view opens the relevant patient binder assessment and page and places the focus on the field that has the query This allows you to find review and respond to outstanding queries in the context within which each query was created iy kee iDataFax User Guide A quicker way to jump to the relevant data field is
114. ge 3 Gender 5 Ethnicity 6 ScreenDate 7 S8P1 amp DBP1 9 SBP2 10 DBP2 11 SBP3 12 D8P3 DFSTUDY DFPLATE OFSEQ 1D PINIT AGE SEX RACE RACEOTH SIDATE SISBP1 S1DBPL S1SBP2 S1D8P2 515873 108P3 S2OATE 1 01001 LK 66 1 2 15 09 10 142 110 146 110 144 110 2 01002 KAH 62 1 1 15 09 10 138 098 140 100 142 100 ws 01003 SHA 37 1 15 09 10 168 102 164 102 164 104 a 01004 JHC 592 1 15 09 10 QM 1s 10S se 108 Mier sat 01005 wko 57 1 1 15 09 10 148 146 106 144 104 6 01006 PJW 66 1 1 15 09 10 188 102 186 104 188 100 8 01008 LMS 58 1 1 15 09 10 172 100 170 100 168 100 9 01009 HGF 42 l 1 15 09 10 148 100 146 100 144 100 A 10 01010 RJA 65 1 1 15 09 10 148 100 146 100 144 100 SSS SSSSSS S SS SSSSS S S S lt i gt Back Map data fields Valid 10 10 records Format nnn Legal 30 150 M autoCorrect _ Cancel __ Next Save data 1 The Next Save data button can be used to either import the records to the study database or save them to a file on disk 2 Only valid records displayed in the spreadsheet will be saved so make sure to select Get All and check your Filter options before proceeding to the next step Step 5 Save Data Records 104 8 11 Importing Data Records Next Save Data iDataFax Import Records to DataFax Database o gt 10 valid records Mode _ New add data records to the database C Replace replace existing data records Q Merge add data records to the databas
115. ge has any problem fields The Incomplete button will be available even if the page has no obvious problem fields This allows you to flag a record as in need of additional work even DataFax is not aware of what that work is The Pending button will be unavailable if the page has advanced beyond new data entry to Incomplete or Final status unless your permissions include Data View with select This permission is typically restricted to study coordinating personnel who may demote problem records to Pending status to exlude them from statistical analyses until the problem is resolved 4 6 Correcting Key Fields Each data record has 4 numeric key fields study page assessment and patient Together they uniquely identify each data record in the study database It is critical that these keys are correct and typically they will be automatically set to the correct values But if you discover an error it can be corrected by selecting Change Keys from the Page menu and using the dialog illustrated below 36 4 6 Correcting Key Fields Page Change Keys 999 iDataFax Change Keys ange from 25 The study number can only be changed if the data record has an image When Page the study number is changed all images are sent to the router and the data Change from 003 to 002 record is deleted from the current study It is not possible to move a data record Assessment directly to another study even if you Change from to have th
116. ging the Auto Logout preference The definition of this page has changed This page needs to be reviewed centrally before you can access it again Please notify your study coordinator This message arises when the number of fields on a page has been changed so that its definition no longer matches the data already existing in the database The data records for the page will need to be reformatted before you can access them Contact your iDataFax Study Coordinator or System Administrator This page can not be saved with status Final because of problems identified by edit checks Possible Cause Solution Message Possible Cause Solution Message Possible Cause Solution 13 3 Programs 13 3 Programs Edit checks that are set to execute upon saving the page may cause certain data fields to be marked with an outstanding query or an illegal data value If either or both exist it will not be possible to save the page with status Final Review the page for any outstanding queries blue fields and or illegal data values red fields and either correct those problems or save the page using Pending or Incomplete status Error in saving record changes Cause A valid date time stamp could not be created Either iDataFax can not obtain a valid date and time from the computer on which it is running or the value obtained is more than 48 hours ahead or behind the value obtained from the study database server
117. gnature line or click the right mouse button to cancel this operation After clicking the left mouse button once the screen will update with the shifted image If you make a mistake select Reset to undo the shift and try again 11 6 3 Flip Selecting Flip from the Page menu turns the page upside down Selecting it a second time will return the page to its original position 11 6 4 Cut Occasionally you will receive a faxed page which is really 2 pages or more joined together This will be evident by a page length count far greater than 1050 pixels and also by the vertical scroll bar which will be reduced to half the screen length or less depending on the number of pages joined together In such cases you need to cut the one long page into individual pages at the appropriate page boundaries Selecting Cut from the Page menu brings up a horizontal line Move this line to the desired cut position and then click the left mouse button to register it or the click the right mouse button to cancel After the cut point is registered a second dialog box will appear asking you to confirm this action Click OK to cut the page or Cancel to abort A page cut operation can not be reversed thus make sure you want to proceed before confirming this action Cutting a page creates 2 pages from the original one You will see this confirmed by an increase of 1 in the number of faxes reported in the top border of the router window The top half of the cut
118. he data forms correctly 20 3 3 How can make sure that I m completing the data forms correctly Here are the steps we recommend _ Double click a patient binder to open it Double click all of the assessments you want to open Click the page you want to start on It will then appear in the data window You can go to any page at any time by clicking it in the patient binder list Also the up and down arrow keys can be used to move through the pages of the all the assessments you opened When you have found a page you want to work on press the Tab key or click anywhere in the back ground of the data window This will put the focus on the first data field at the top of the page and the field will be highlighted Complete the first data field using the keyboard to enter text and numbers or the mouse to select a choice option or move a visual analog slider Choice options can also be selected using the number keys 1 1st option 2 2nd option etc and visual analog fields can also be completed by using the right and left arrow keys to move the slider along the scale If a help message has been specified in the study setup it will appear at the bottom of the data window As you enter values watch the field color It will change from red required fields or yellow optional fields to white when a legal value has been entered The help message is often used to display the legal values expected for each field
119. he Search menu The Search dialog includes an expression editor which can be used to create simple algebraic statements describing the desired data records Expressions can be entered directly in the text widget or by clicking on the Fields Symbols Codes and Functions in the appropriate order Select Search Expression Editor AAA iDataFax Expression Editor Page 001 Blood Pressure Screening Visits Expression SAGE gt 65 amp amp S SEX male S AGE gt 70 amp amp S SEX female Fields Symbols Field Name Description Type FSTA hoice label DFSTATUS choice Gabe equals This example 2 DFVALID number t not equal selects men 65 3 DFRASTER string n contains and older plus t t 6 DFSEQ number Sa RA women 70 and 7 ID Patient Number number gt greater older p lt less equal a 8 PINIT Patient Initials string zi tae Clicking OK will 9 AGE Age number Il oF 3 add this expres 10 SEX Sex choice label amp amp and sion to the Search dialog 11 RACE Race choice label Codes g 12 RACEOTH Race Other specify string 0 blank 13 SIDATE Screen 1 Date date 1 male 14 S1S8P1 Screen 1 Read 1 systolic number 2 female 15 S1D8P1 Screen 1 Read 1 diastolic number 16 S1 8P2 Screen 1 Read 2 systolic number Functions 17 S1D8P2 Screen 1 Read 2 diastolic number concat s1 2 0 18 S1SBP3 Screen 1 Read 3 systolic number sore oe A f f t inde
120. he date and time at the bottom of the screen If a Help message has been defined for the current data field it will be shown in the help message window at the bottom of the screen to the right of the Last Save date 8 4 Working on a Task If a set of task records was assembled in Data View it remains in effect on switching to List View only those CRF pages and data records that met the task criteria will be displayed To see all CRF plates in the page list and all data records in the data table select Show All Pages and Show All Records respectively This does not cancel the task set Task records can still be identified by the T icon which appears on each task record in the data table To cancel a task and see all data records choose Select All Records in List View or Data View 8 5 Selecting Data Fields To select a subset of the data fields on the current plate select Select Field Selection and use the dialog illustrated below Select Field Selection aA iDataFax Field Selection Page 001 Blood Pressure Screening Field Generic Name Unique Name Description Type Format Legal Values 77 wo iD001 Patient Number number 1001 99999 PINITOOL Patient Initials AGE number 16 79 10 sex SEX Sex choice 1 2 11 RACE RACE Race choice 0 1 2 3 4 12 RACEOTH RACEOTH Race Other spec string M 13 SiDATE S1DATE Screen 1 Date date dd mm yy 01 01 01 today Vv 14 S1SBP1L SISBPL Screen 1 Read 1 number 60 300 K4 15 S1
121. he field has been corrected or the reply or reason have been approved the color changes to green A reason explaining a data value can be added to any data field This is particu larly useful as a way of explaining unusual values and thereby avoiding a data query from the study coordinating center iDataFax colors fields with a new reason orange and gives them a Pending status If the coordinating center accepts the reason the field color changes to green and reason status changes to Accepted If they do not accept the reason field color changes to blue and the reason status changes to Rejected A reason can be modified which starts the review process over again None of the changes you make to a page are sent to the study DataFax server until you click one of the 3 Save buttons at the bottom of the screen Final Incomplete or Pending If you leave the computer without saving your work iDataFax will time out after a few minutes and the changes you made will be lost However you will be warned that this has happened the next time you connect to the study and you can opt to return to the same page 13 2 Common Error and Warning Messages This section describes some common messages that users may encounter during their use of iDataFax Table 13 1 iDataFax Login Message Possible Cause Solution Server Unreachable Check server and or your network connection There is no internet connection available or server address name
122. hoice 0 7 1 3 3 DFRASTER string 4 4 DFSTUDY number 253 5 5 DFPLATE number 1 6 6 DFSEQ number 0 65535 0 7 7 1 Subject ID Patient Number number S ids 8 8 2 Initials PINIT Patient Initials string 9 4 Age AGE Age number 16 79 19 10 D8P2 10 3 Gender SEX Sex choice 1 2 Li 11 S8P3 d ih 5 Ethnicity RACE Race choice 1 4 12 12 DBP3 oS 12 RACEOTH Race Other s string 13 6 ScreenDate S1DATE Screen 1 Date date 01 01 dd 14 7 S8P1 1S8P1 Screen 1 Rea number 80 300 nnn S1DBP1 Screen 1 Rea number 30 150 ann 16 S1S8P2 Screen 1 Rea number 80 300 nnn 17 S1D8P2 Screen 1 Rea number 30 150 ann 18 S1S8P3 Screen 1 Rea number 80 300 nnn 19 S1D8P3 Screen 1 Rea number 30 150 nnn a Back Input Data File Sea Map Filew Revert Cancel Next Review data 1 To specify the mapping of input fields to database fields simply drag fields from the left panel to the right panel beside the corresponding Generic Name for the field in the study database or use the buttons to move the current input field in the left panel to the next available slot after the current input field in the right panel For example clicking the right going arrow in the above dialog will move input field 9 SBP2 to Plate 001 field 16 S1SBP2 2 The double arrows move all fields to the right panel or back to the left panel and can be used when all fields in the input records exactly match fields in the destinati
123. iDataFax User Guide Clinical DataFax Systems Inc Table of Contents Table of Contents Chapter 1 Introduction i SE 4 Is data transmission over the internet secure 2 lt 5 7 Is any patient data stored on my local hard drive 1 9 How hard is it to navigate among the various study forms for each patient 10 Can use iDataFax for more than one study atatime 1 If don t like this or have time for it can switch to faxing 2 How do get started Me fo ona ae teen oe Fae 13 After connect to a study how do enter patient data para para puare puare pnra pnra pnra gt ay ary ere OONNOTAAIAIARHRKRARWWWWWWND 1 14 What do do when I m finished entering patient data Chapter 2 A Guided Tour 2 2 2 User Permissions E pra 12 12 bee i 13 15 a 16 So kt tyes sk ik ot Op A Ok 18 SS ie At A hed aed 19 19 3 2 Can print a copy of a patient binder 20 et i 20 22 ea ee a a a a ee 23 3 6 What are queries and where do they come from www 24 25 Pop 8h axe oe SG Ps 25 26 27 3 11 Can I indicate that a patient assessment is unavailable 27 i 28 3 13 Do need to save the changes have made 28 29 3 15 What s the best way to find all outstanding problems 29 3 16 Why did my iDataFax session Auto Logout 30 32 3 18 What should do if have questions 32 Chapter 4 The DataView
124. in diastolic or systolic blood pressure between visits It could be programmed to add a query if a suspicious change is found and to do nothing if a query for this problem has already been added to the blood pressure field in question 49 iDataFax User Guide In this example edit check E Example 9 Search by Program DFmkdrf ec CheckBP is triggered on page 5 P 5 at all follow up visits S 21 24 which Task Edit Checks BP Review are currently at level 2 v 2 Mode 2 Validate i By running this edit check in a task the a E Gf Enable edit checks user can review the blood pressure Search lt Data J Queries Reasons F By program readings recorded on the faxed CRF inpakt ac ES ECES 23 26 ae pages and verify that any unexpected changes are not the result of data entry errors 4 9 Adhoc Record Selection In addition to using predefined tasks to select data records and set work flow modes and levels users who have Data with Select permission can perform adhoc retrievals using the same dialogs that are used to define tasks Working in this way requires an understanding of the study work flow plan and is thus most appropriate for central data management staff This permission will typically not be enabled for the clinical sites and thus the features described in this chapter may not be available to all users 4 9 1 Changing Mode and Level iDataFax allows you to work in 5 different modes and to keep track of data reviews and o
125. in the study database Mode Replace Merge and input keys match a database record but DFRASTER differs from the current database value Mode Replace Merge and input keys match a database record but input record is identical to the database record Mode New but the record already exists in the study database Mode New but DFRASTER is mapped and not equal to 0000 0000000 User does not have the permissions needed to import the record 12 Metadata Queries Reasons QC Reports In addition to displaying patient data records List View also displays queries reasons returned QC reports and records that have classified as lost Users who have permission to see a data record automatically have permission to see queries and reasons attached to fields on that record Permissions for QC reports must be granted explicitly through plate 501 otherwise QC reports will not appear in List View Lost data records follow the same permissions as regular data records 107 iDataFax User Guide Changes can only be made in Data View Double clicking anywhere on a metadata record in List View switches the user to Data View with the focus on the field that was double clicked Selecting the Return to List View button in Data View will return the user to the field that was double clicked in List View Queries can be searched using Select Search to invoke the dialog illustrated below This dialog shows the number of queries that meet all of the current s
126. ing DF_QCreports DF QCsent DF_CTerfs Summary report of records received from each center Dr _cTpages Summary report of CRF pages received by fax and or email DF_QCstatus bP_CTqcs Summary report of external QC notes for each center DF_QCupdate DF_CTvisits Number of patients who have reached each visit at each center DF_QCview DF_SScenters audit Trail DF_SSschema OF_ATerts z Track keys associated with a CRF page over time DF_SSvars DF ATfaxes Trace validation history of each page in selected faxes DF_SSvisitmap bF_ATmods Trace database modifications over a time period DF_WFerfs x DE WFerfcnorwy a jarel e DataFax Reports DataFax includes a number of standard reports that can be used in any study The list of reports which you have permission to run will appear when you select DataFax Reports top left 15 iDataFax User Guide e Study Reports Any study specific reports created by the study coordinating center will be listed when you select Study Reports e History Reports that you have already run during the current login session are saved and will be listed when you select History Selecting a report in the history list will display the previous output for that report e Options Most reports have a number of options which can be selected from the drop down options list to control what the report will produce e Explain All of the DataFax Reports and most Study Reports come with a description of
127. ious page printing pages and determining where each page came from context 11 6 1 Rotate Select Rotate from the Page menu to correct page skew This is needed if the page signature line at the top of a study CRF is not perfectly horizontal Page skew usually results from failure to adjust the page guides snugly against the sides of the CRF pages when they are being scanned by the fax machine 119 iDataFax User Guide Instructions for this operation appear in the status line at the bottom of the router window Click the left mouse button on the top left end of the horizontal signature line and then click again on the top right end of this line or click the right mouse button to cancel this operation When the operation is complete the screen will update to show the realigned image You can undo a rotation by selecting Reset from the Page menu 11 6 2 Shift Use Shift when the page does not need to be rotated Shift is used to register the upper left corner of the page signature line found at the top of all DataFax CRFs The upper left corner of this line is used as the CRF reference point for DataFax ICR and thus must be registered before the page is identified and routed to the study database If you fail to do this the ICR software will look for data in the wrong places on the CRF page and will thus fail to find data fields and will leave them blank To shift a page click the left mouse button on the top edge of the horizontal si
128. is unknown it will be represented by following the sender id label If DataFax can determine the fax number or email address of the sender s fax machine as in the above example it will appear following the sender id label 11 6 14 Reset Selecting this function or the Reset Image button in the bottom right corner of the screen will undo all Rotate Scale Shift Flip Trim and Truncate manipulations that have been made to the current page the only exception is Cut which can not be undone Reset is performed automatically if you select a different page before identifying the current one to send it to the desired study database Once a page has been identified it is gone and any page manipulations become permanent 11 7 The Action Menu This menu contains all of the functions which dispatch and remove pages from the DataFax identify folder where all unidentified pages are stored All actions are immediate Once committed they can not be undone 122 11 7 1 Rotate Shift Identify 11 7 1 Rotate Shift Identify Most CRF pages can be cleaned up identified and routed to the appropriate study database in a single step by selecting Rotate Shift Identify from the Action menu Follow the directions at the bottom of the router window to identify the CRF page signature line The page will then be deskewed and shifted and another attempt will be made to read the bar code When this has been done enter or correct the keys Study Plate
129. ith a query explaining why and request Status C Approved Cl Rejected Pending ing a correction or additional information Site Patient ID Task records all data records with Assessment reasons that have status Pending Mode Page is set to Modify and the sign off level is field set to 2 but we could also have used Level Edit mode which would leave the reasons Crean at their current work flow level if nin S As for example 2 this task should also be performed using the Field Review Queries amp Reasons dialog SEED done Clear Cancel The following examples illustrate how tasks can be defined by running a program that generates a DataFax retrieval file as output DataFax includes 2 standard programs which are designed for this purpose DFmkdrf jnl which selects records form the study journal files and DFmkdrf ec which selects records identified by edit checks We will only show some examples here A full description of these programs can be found in the Appendix at the end of this guide If you need to write a custom program an explanation of DataFax retrieval files can be found in the DataFax Programmers Guide Example 4 Search by Progran DFmkdrf jnl In this example double data entry is performed on data records with associ EESK ODE from faxed CRFS ated images image yes which were Mode ODE H saved by other users xu whoami at Sign off Level 2 TE A Enable edit checks level 1 v 1 with status final or incom plete s
130. keys are entered in the spread sheet for a second page the selection check box will become unavailable for that page Oo Each imported page becomes the primary image for its data record The previous primary image if any becomes secondary o iDataFax builds a task set of all imported pages and displays the first task record when the user closes the results dialog If any of the imported pages did not have a matching data record before 64 4 15 Importing Patient Documents import a data record with pending status is created and added to the task set The user then performs data entry by comparing the data fields with the values recorded on the imported CRF or worksheet and entering or correcting the data fields as needed All imported pages should be processed before releasing the task set but if this is not possible they can be saved using File Save Data Retrieval File They can then be retrieved and completed another time using Select By Data Retrieval File Spread Sheet Keyboard Short Cuts Tab or Right Arrow moves forward across the cells in each row Shift Tab or Left Arrow moves backward across the cells in each row Pressing Enter on a Patient cell or completed Plate or Visit cell moves down to the next cell in the column as does the Down arrow key Shift Enter on a Patient cell or completed Plate or Visit cell moves up to the next cell in the column as does the Up arrow key If you Know the numeric
131. l E 077 7 o j 2 042 Baseline Meds page 2 9 11002 BBB 15 01 11 2 14 03 85 070 0 185 zE 070 1 l 4 M age 3 See keel pep ced 10 13002 ABC 02 01 10 2 ER 150 0 150 MM 031 1 1 101 isse ist O 102 Early Termination Report 11 15001 JRF 02 01 11 2 9 03 74 Mo i ii metadata QC Reports 12 15002 JMP 05 12 10 2 04 10 70 147 8 175 068 9 052 3 2 metadata Reasons s A REE r r z ad G 13 15003 RTW 01 03 11 2 02 01 64 155 5 068 5 055 2 1 metadata Lost 14 15004 TYR 02 02 11 2 03 03 55 160 0 063 0 051 4 1 z ar Switch to Data View Query Problem inconsistent reply required Details Initials TIF on this page differ from initials TIR from Visit O Plate 1 Status Outstanding Created dwt June 22 2011 16 44 10 Resolved DataFax 2 el olo17 Patlont Number Ue Pee eee eee eee 63 Ptate 2092 Visit 001 Paticnt initials FML PATIENT ENTRY FORM Entry Date dd mmi yy Missing Value Eligtbitity Reason for Data Value F Yes G No gt Explain Does the patient atii mast the eligibility criera Save 1 view mode Last Save June 22 2011 16 36 33 Use underscore for missing initials e g M_T Permissions A plate is selected from the list of study plates in the left panel Only plates which you have permission to see will be shown and when a plate is selected only those records which you have permission to see will be shown as rows in the table and columns
132. lace mode and must equal 0000 0000000 when importing new records in New mode The time stamps DFCREATE and DFMODIFY can not be mapped They are completed by the server when records are imported The Import dialogs have 2 buttons in the lower right and left corners used to move to the next and previous step respectively During mapping the Next button can be used to review the current mapping of data records and the Back button can then be used to return to the mapping dialog If other data files with the current mapping will be imported at some point the mapping can be saved to a file using Map File Save Current Mapping to File If you forgot to specify a saved mapping file in the previous dialog it can also be selected in the mapping dialog using Map File Read Field Mapping from File Use the Revert button to undo all current mapping so you can start over and the Cancel button to abort the whole File Ilmport Data operation When mapping is complete select the Next Review data button to proceed to the next step Step 3 Review Input Data Records Next Review Data 8 4 8 iDataFax Import Data from Users jack tmp ScreeningData_150910 dat _ Verify Correct input data records then select Next Save data Filter invalid illegal _ autocorrect _ no problem 1 Subject 2 Initials 4 Age 3 Gender 5 Ethnicity 6 ScreenDate 7 SBP1 8 DBP1 9 SBP2 10 DBP2 11 SBP3 12 DBP3 OFS
133. le users Pages are locked and released as the user traverses the page list When a page is selected it and all other pages in the same fax transmission are locked preventing other users from processing the same pages Small icons show the current status of each page in the page list Exclamation mark icons identify pages that are locked by the current user lock icons identify pages currently locked by other users and red X icons identifies pages that have been processed routed to a study deleted or saved The user s login name and the DataFax server name are shown in the title bar and a similar message bar at the bottom of the screen shows the number of pages to be routed the number of pages locked by other users busy and the current image name and size in pixels width x height Router work flow typically proceeds in 3 steps 1 select a page 2 perform image processing e g rota tion flip etc and 3 identify the study it belongs to using the widgets at the bottom of the screen or print or discard it using the menus at the top of the screen 118 11 5 The File Menu Pages without barcodes may also be identified provided the user is able to determine the study plate and visit numbers using other features As an aid to identification the image can be resized from 50 200 using the Zoom option This has no effect on the size of the image stored in the study database If most pages have similar keys the Preserve keys
134. lect a new page in List View thus the spreadsheet will be up to date each time you select a new page Also iDataFax retrieves the current version of each data record when you select it in the spreadsheet thus again the record will be up to date at that instant However changes made since the records were retrieved arising from other users or batch edit checks are not automatically displayed thus some or all rows in the table may become out of date while you are viewing them As needed you can update all records at any time in List View using the Select Refresh menu option As in all other views what you see and what you can do will depend on your user permissions which may be different for each DataFax study Figure 8 1 View List 87 iDataFax User Guide iDataFax File File Edit Ee Select Show Page Field Help anA Fax F iDataFax dwt t420sparc datafax com DEMO 253 List 2007 1 2 5 of 28 Data 3D ID A PINT EDATE EUG EUGEX BDATE WTKG WILE HTCM HTIN PULSE SMOKE EXERCIS Queries Q F P 5 Ta ols 10 l 7 4 001 BP Screening Reasons XR 1006 BDOS 02 01 11 2 a 07 10 54 076 0 167 5 ie 072 0 046 1 3 002 Patient Entry Form Ranais E 004 003 Medical History 5 p 5 2 06 1 004 Baseline Meds page 1 we HS 2005 NNN 22 12 10 2 05 06 32 a 155 5 170 E 2 005 Monthly Follow up Fom 5 006 PWR 10 09 10 2 06 07 40 065 5 180 070 4 4 006 Patient Evaluation Report por m 11 2007 11 11
135. lecting File Save Data Retrieval File and using the dialog illustrated below File Save Data Retrieval File 3 iDataFax Save Data Retrieval File Study 253 demo253 Directory On entering an output directory folder and press l i ing Return any existing DRFs in that location will Users jack tmp be listed testl drf testing jack 07 12 20 Output can be written to a new DRF or an existing DRF can be selected and overwritten To export the records displayed in the List View window to a DRF specify File an output file a short descriptive label for the DRF a comment for record level iDataFax help whether output overwrites or appends to the output file Users dwt tmp_dd eligibility review drt Description eligibility problems Display comment review eligibility criteria An existing DRF can be selected and deleted Options using the Delete button Write to File Append to File Delete Cancel f 8 10 Exporting SAS Data Sets Users with permission can create and export data sets in SAS format to a file location on their local disk by selecting File DFsas and using the dialog illustrated below For instructions on creating and running DFsas jobs see the DFsas chapter in the DataFax Programmer s Guide 98 File DF sas AnG DFsas Jobs testl test2 test4 iDataFax OF sas 8 10 Exporting SAS Data Sets Ld VERSIONS OFsas ACSVERS ACSDATE and Ofsas awk RCSVERS RCSDATE
136. led And different users can access their studies from the same computer s All you need to provide is your login name and password 1 8 Can anyone impersonate me within iDataFax Permission to read write and modify patient data is defined by the study coordinating center for each iDataFax user These permissions determine which study sites patients assessments and individual data pages each user can create view and modify It would not be uncommon for more than one person to have permission to enter data for the same patient at a given clinical site however all data entry is recorded with the user s login name date and time thus a complete history is maintained of all database transactions Your login name plus a password constitute your electronic signature By protecting your electronic signature and making sure you logout of iDataFax before leaving a computer workstation you can ensure that no one can impersonate you and perform data entry that will be attributed to you 1 9 How hard is it to navigate among the various study forms for each patient Some of the frustration with EDC systems arises from dissimilarity between paper work sheets and data screens and the difficulty in navigating through the windows of an unfamiliar system to find what you want By comparison a patient binder full of printed forms organized by study assessments from begin ning to end with tabs identifying each assessment is quite easy to use iDat
137. level lock is immediately requested and the patient binder is then opened to the same page that was being entered in Fax View If the patient ID lock is obtained the user enters Data View in Edit mode with their lowest write level which means that existing records which are modified and saved will remain at their current workflow level and any new data or metadata data will be saved at the user s lowest write level If the patient ID lock can not be obtained the user can still switch to Data View in View Only mode However because the record level database lock was released it is possible that when you return to Fax View you will find that you can not continue with data entry because someone else now has the dataabse lock for that record If the patient ID lock is obtained on switching to Data View any record in the patient binder can be modi fied provided the user has modify permission except for the originating Fax View record which will be displayed in View Only mode This record must be entered in Fax View You can easily return to it by selecting Switch to Fax View which takes you back to this record in the Fax View record list When a new record is saved in Fax View and the user moves to another record the database lock is released and the record becomes available to other users All saved data records remain in the Fax View list until they are released or the next set of new records is retrieved This facilitates returning to a previ
138. lso known as US ASCII used in English text Thus currently iDataFax blocks the entry of the accented or unicode characters used in many other languages iDataFax also blocks the character which is reserved for use as the field delimiter in data and metadata records 4 5 Saving Data and Metadata Changes made to each page need to be saved before you move to the next page If you click on a differ ent page before saving changes a dialog will appear asking whether you want to save or discard the changes you have made You can save changes to data and metadata and move the record to the sign off work flow level by select ing one of the available Save buttons at the bottom of the data window e Final data entry is complete there are no outstanding problems no red or blue fields e Incomplete additional work is needed to complete this page e Pending use this option during new data entry to indicate that you have not finished your first pass through the page and want to complete it before it is reviewed by the study coordinating center e Lost this button is only available on records that have been marked Lost Use it indicate that you have completed a task to move the record to the sign off work flow level or to save a query that may have been added to the patient ID field The Lost button will appear and will be the only button available if the page has been marked Lost The Final button will be unavailable if the pa
139. m available available If login is successful you will see the study selection dialog with a list of studies you have permission to access on the DataFax server to which you have connected Each study is identified by number name and current status available or offline To work ona study double click the study name or select it and click the OK button Press Cancel if you decide not to continue with the login Note that both dialogs include a Help button which can be used to access this user guide which is also available from the Help menu after you login Thus the user guide is always avail able even when you do not have an internet connection 2 2 User Permissions 2 2 User Permissions When iDataFax opens the study you have selected you will have access to only those patient records and program components that the study managers have granted you permission to use Typically each partici pating clinical site will only have access to their own patients some subset of the available reports and may have restrictions on which study forms can be seen modified printed and exported and on which views are available The iDataFax views include Data used to enter modify and review patient data Queries used to review and respond to questions from the study coordinating center Reasons used to review reasons that were entered to explain particular data values Fax used to enter dat
140. made by editing the values in the spreadsheet As illustrated in the example below Subject ID 91002 was corrected to 01002 and for Subject ID 1005 S1DBP1 was corrected from 156 to 106 108 iDataFax User Guide 6 The data records can be filtered using the check boxes at the top of the dialog to display any combi nation of records with invalid illegal and autocorrect values or records with no problems at all 7 Auto Corrections Auto corrections that change the input value include Strings longer than the field store length are truncated Numbers are truncated to the number of decimal places in the field format Numbers greater than the field store length are imported as blank fields Undefined codes in choice and check are imported as blank fields Invalid dates are imported as blank fields Auto corrections that merely change the format of the input value include String mapping is applied if specified in the field setup Leading zeros are added where required by the field format Leading zeros are removed where not required by the field format Leading signs are removed from unsigned fields Input date format is converted to database format if specified in step 1 Step 4 Get All Data Records Get All ANA iDataFax Import Data from Users jack tmp ScreeningData_150910 dat Verify Correct input data records then select Next Save data Filter __ invalid illegal _ autocorrect _ no problem 1 Subject 2 Initials 4 A
141. mentation that can be accessed by selecting the report name and then selecting the Explain button The documentation generally includes a description of any options that may be specified before the report is Run and an explanation of the report output 9 4 Report Options and Database Permissions Most reports include options that can be used to alter what the report produces For example DF_PTerfs which displays a summary of CRF status for patients includes options to specify which patients visits and CRF pages are to be included Report output also depends on your database permissions and will only include information based on data records you have permission to read Selecting the Options widget displays the entire options list Selecting an option from the list copies it to the Specify window with the part you need to change highlighted For example the DF_PTcrfs option used to limit the CRF history to patient visits occuring since a specified date is t yy mm dd When this option is selected it is copied to the Specify window with yy mm dd highlighted Changing this to 07 05 15 yields the option t 07 05 15 which limits the output to patient visits which occurred after May 1 2007 9 5 Running Reports Selecting the Run button runs the report with the options currently listed in the Options Specify window and displays the results in the large scrolling window below the Run button The output from each new report replaces the output from the
142. meric value in the spreadsheet or right click a cell to use the selection dialog Enter the Plate Page number first The Visit Assessment selection list will then show only those values that are consistent with that plate per the study visit map 63 iDataFax User Guide To prevent errors iDataFax will not allow pages to be imported if they are barcoded with a different study number Also users can only import pages for data records which their study permissions allow them to modify If a key field contains a value that is illegal or not permitted the cell will appear purple and the page selection check box will not be available unless the problem keys are corrected If a page contains a bar code for a different study or the identified record is at a workflow level the user can not modify a red X replaces the page selection check box indicating that the page cannot be imported After entering valid keys a check box appears which when checked indicates that the patient binder can be locked and that the page has been selected for import If the page can not be imported because the patient binder is locked by another user a lock icon replaces the check box and the message This record is currently locked by another user is displayed When the pages you want to import have been identified and checked click the Import button and enter your password Each page will be attached to the specified data record as a primary or secondary image a
143. ms used to collect study data for an individual patient Within iDataFax patient binders are displayed in a list by patient ID number with an associated icon that shows whether the binder is empty or contains recorded data and whether that data is currently complete incomplete or pending 129 iDataFax User Guide Pending Query Reason Save During new data entry a page can be saved with status Pending to indicate that you are not finished with it and plan to return to it shortly These pages are saved at work flow level 0 and do not move to higher levels until they are saved with status Final or Incomplete Typically pending pages at level 0 will not be reviewed by the study coordinating center until they progress to level 1 or higher Pages which have progressed beyond level 0 can not return to level 0 but they can be reset to status Pending to indicate that there is something seriously wrong which needs to be corrected before the data can be used in statistical reports The ability to demote records this way is restricted to users with Data View with Select permission iDataFax marks Pending pages with a yellow dash see also Final and Incomplete The study coordinating center may add a query to any data field to request a correction or clarification iDataFax colors fields with an outstanding query blue When a reply is provided to a query or a reason is added to explain the field the color changes to orange and when t
144. n all imported records or only those missing and illegal values which might be useful if you want to review any queries generated during import As when creating any task set you also need to specify the mode sign off level and edit check status to be used on records in the task set 9 When these options have been completed select Next import data to proceed to the final step illus trated in the dialog below Step 6 Confirm Import Data Next Import data iDataFax dfpassword WARNING New queries will be created for any missing and illegal values that are imported but only if you have permission to create queries on the imported records Existing queries will not be replaced WARNING Reasons will be created if import changes a data field but only if you have permission to create reasons on the imported records Existing reasons will be modified if the data value is changed The import data action cannot be undone Please enter password Cancel 1 If you selected the options to create queries and reasons in the previous dialog you will see the warning messages illustrated above 2 To start data import enter your password and select OK or select Cancel to return to the previous dialog Step 7 Review Results 106 8 12 Metadata Queries Reasons QC Reports and Lost Records Next Map Data Fields 1 2 iDataFax Import Data idataFax Import for Study DEMO 253 etarte
145. n the data Page Selection view 2 Double click the patient binder to open it 3 If you only want to print selected pages open the corresponding assessments Current patient 4 Select File gt Print to open this dialog ent ta 5 Select one of the Page Selection options en ens 6 Select one or more of the Print Options M Blank pages e Blank Pages CRF pages which do M Completed pages not yet contain data F Expand text fields for pages all e Completed Pages CRF pages containing data values Data Primary Image side by side j e Expand text fields to avoid trun images cating long text entries e Data Primary Image to see both the data and the supporting CRF Color Option e Images any faxed or scanned images that exist for the selected M Apply field color for completed pages pages primary only or all images 7 Check Apply field color if you want the data fields printed in the current color Print Cancel shown in iDataFax 8 Click Print In the example above the Current Assessment is selected and both Completed and Blank Pages are checked This produces one copy of each page in the current assessment with data values included on pages where data has been entered Note The patient ID number and assessment number are printed on every page even if you select Blank Pages Make sure you have selected the correct patient binder before printing it 3 3 How can I make sure that I m completing t
146. n to the page but any unsaved changes can not be recovered Any keyboard input or mouse movement inside the iDataFax window will reset the timer A default and maximum time will have been configured by the study coordinating center You can set the timeout interval to a value not exceeding this maximum in the user preferences dialog 2 4 Queries View The Queries View lists data queries from the study coordinating center iDataFax File View Show Query Help skakal Data iDataFax jack Demo Study Site 1 4 queries 2 resolved and 2 outstanding created between May 12 2006 and May 17 2006 lO Site Patient Reasons je Field Problem Status amp Replies Site 1 General Hospital TH x 1002 Baseline Medical History 2 Atrial Fib Duratn Mon lt 18 Illegal Outstanding dwt May 11 2006 2 31 51 PM Please change to 01 years and 06 months and complete all durations in this way Thank you x 1002 Baseline Medical History 2 Atriai Fib Treatment Yes Other Outstanding dwt May 11 2006 2 34 07 PM What type of treatment is the patient on 4 Valvular HD Duratn Yrs 45 Other Pending review Does the patient have any limitations or problems related to Reply jack May 11 2006 5 42 18 PM this value defect _ No z 1003 Baseline Current Medications 1 Drug Name Missing Resolved corrected dwt May 16 2006 5 17 22 PM Baseline Medical History You can filter the list of queries in v
147. neral system General disorde 10015667 I Fatigability Fatigue Asthenic condit General system General disorde 10016252 Fatigue Fatigue Asthenic condit General system General disorde 10016256 Lassitude Fatigue Asthenic condit General system General disorde 10023929 Prostration Fatigue Asthenic condit General system General disorde 10036985 Tired and heavy Fatigue Asthenic condit General system General disorde 10043886 Tiredness Fatigue Asthenic condit General system General disorde 10043890 Weariness Fatigue Asthenic condit General system General disorde 10047871 Post viral fatigue sy Post viral fatigu Viral infections Viral infectious Infections and 10036323 Post viral debility Post viral fatigu Viral infections Viral infectious Infections andi 10036320 08 9 Show All Fields C Cancel The top section of the dialog shows the field labels and the field values in the currently selected row The bottom section contains a scrolling list of all rows in the lookup table typically with abbreviated field labels at the top of each column If all fields can not be seen clicking Show All Fields will reduce the display size of each column to fit them all within the current dialog The size of each column can be adjusted by right clicking the vertical line separating the field labels and dragging it left or right To search for one or more term
148. ng turns off imputation outputs the value exactly as stored in the study database and creates a character informat for SAS julian performs imputation as specified in the study setup converts the date to a big number of days since 4712 BC and does not create an informat statement as SAS does not need one for numbers Date imputation can be turned off for all dates regardless of study setup specifications and regardless of which date formats are selected by specifying IMPUTE no in the global statements After saving a DFsas job file it can be executed at any time by selecting the Run button A confirmation dialog appears with one option Force DFsas to include all specified plates Select this option if you want to include all of the plates specified in the DFsas job file even if they do not currently contain any data records If this option is not selected a SAS data statement will only be created for plates with data records After confirming that you wish to execute the selected DFsas job DataFax runs DFsas on the study server and returns a zip file containing a SAS job file and a data file for each plate to the specified RUNDIR on your local PC 100 8 11 Importing Data Records 8 11 Importing Data Records Data from labs and other sources can be imported to a DataFax plate by selecting File Import Data in List View and following the steps illustrated below Permission to use this feature must be granted in the user
149. nning DFmkdrf jnl in iDataFax or if environment variable DFNUM is set to the study number when running shell scripts 2 Input DFmkdrf jnl reads the study journal files and thus will not generate correct output if any of the journals have been removed or truncated 3 Output a DRF record is created for journal records that meet all selection options at some point in the specified time period a d 0 even if these records no longer meet the selection options default or b d 1 if they still meet the selection options at the end of the time period or c d 2 if they still meet the selection options now 4 A DRF record is not created for any record deleted after meeting the selection criteria because a deleted record can not be retrieved from the study database 5 If the keys ID Visit Plate are changed after a record meets the selection criteria a DRF record will be created for both the old keys and the new keys if they both correspond to a current data record 6 The record selection period may be specified using yymmdd yymmdd or yymmdd today a date range or yymmdd or today a single date 7 If the drf option is not specified output is written to standard out 8 If the cases and records options are both specified cases has priority EXAMPLES Output DRF records for data records in study 253 that were saved with associated images by jack or dianne at level 1 in Nov 2007 regardless of whether these records were subs
150. ns view 75 iDataFax User Guide 6 3 1 The Show Menu The Show menu is used to select the reasons to be displayed in the reasons table The following options are available All Reasons show all reasons Approved Reasons show reasons that have been approved by the study coordinating center Rejected Reasons show reasons that have been rejected by the study coordinating center Pending Reasons show reasons that are awaiting central office review Search Reasons displays a dialog used to search for reasons containing specified text strings 6 3 2 The Reason Menu This menu has only one option Go To Data Field and is only available after a reason has been selected in the Reasons table Selecting this option takes you to the Data view opens the relevant patient binder assessment and page and places the focus on the field that has the reason This allows you to find and review reasons in the context within which each reason was created A quicker way to jump to the relevant data field is to double click on the reason in the Reasons table To return to the reasons table after reviewing a reason in the Data view select the Return to Reason View button located at the bottom of the record navigation list on the left side of the screen 76 Chapter 7 The Fax View Chapter 7 The Fax View iDataFax User Guide L iDataFax File Edit _ Select Page Field Help ANA x dwt kepler datafax com DEMO 3 Fax 2 of 16 Data D
151. nual method is locked by the user who selects them This is a lock on the image ID not on the keys which may at this point be blank or incorrect These image locks prevent other users from trying to enter the same new pages in Fax View In large studies with 100s of pages arriving each day and several users working together to perform new data entry it is best to minimize the number of faxes or pages that each person retrieves at a time We recom mend getting 1 fax at a time When entering these records a record level database lock is requested for the key fields ID assessment plate as soon as the user moves into a non key field You will not be able to change data or metadata or save the record if someone has the patient binder locked in Data View or if someone is currently entering another record with the same 3 keys in Fax View However it is possible for multiple users all working in Fax View to simultaneously enter new data records with different assessment and or plate numbers for the same patient The only difference between Raw Data Entry and entering a set of records from faxed CRFs is that Raw Data Entry records do not have images and thus do not have image locks While working in Fax View it is possible to switch to Data View to review and or modify other records for the same patient When a user selects Switch to Data View the record level database lock acquired on the key fields in Fax View is released a Data View patient
152. omplete all Missing Page Queries ink you x 1002 Baseline Data Correction Queries Yes Other Outstanding dwt May 11 2006 2 34 07 PM Data Clarification Queries the patient on x 1002 1 Month amp Outstanding dwt May 17 2006 3 53 04 PM X 1002 1 Month A Outstanding Queries Modified in the Past gt blank Missing Outstanding dwt May 17 2006 3 53 48 PM x 1002 1 Month Outstanding Queries Modified More Than gt Missing Outstanding dwt May 17 2006 3 53 32 PM x 1002 1 Month A dissing Outstanding dwt May 17 2006 3 53 14 PM x 1002 1 Month A Search Queries Missing Outstanding dwt May 17 2006 3 53 26 PM x 1002 1 Month FONOMeUp MOntnIy Followelp New bottle hot diepensed Not Done Missing Outstanding dwt May 17 2006 3 55 03 PM x 1002 1 Month Follow up Monthly Follow up New Bottle Med Code Not Available Missing Outstanding dwt May 17 2006 3 55 35 PM e Select View gt Queries to open the queries view e Select Show gt Outstanding Queries All outstanding queries marked with a red X will be displayed If none are displayed you have no outstanding queries congratulations e Double click an outstanding query from the list to jump to the data field with that query in the data view where you can review and respond to it If you resolve a query it will be removed from the list when you return to the Queries view 3 8 How should I respond to queries Some queries can be resolved by correcting the data
153. on plate 3 Once moved to the right panel input data fields can be matched with the correct Generic name by dragging them with the mouse or by using the up and down arrow buttons 4 lf the input file contains fields that are not included in the plate they can be omitted It is not necessary to match and import all fields from the input records 5 If the plate contains fields that are not included in the input file a value can be specified under Value if not mapped otherwise the field will be blank in all imported data records If the word today is speci fied for an un mapped date field the current server date will be inserted when the data records are 102 14 8 11 Importing Data Records imported The only field that is required in the input file is the patient ID The visit key field can be specified in the Value if not mapped column as can any other field that you want to set to the same fixed value for all input records Database records for a specified plate and visit can be deleted by importing a file that contains only the patient ID and then specifying the relevant visit number and setting status 7 in the Value if not mapped column No other fixed values are required Plate fields DFRASTER DFSTUDY and DFPLATE are set automatically and need not be mapped but if they are then DFRASTER is treated as a key field which must match an existing record when importing replacement records in Rep
154. on the current field but only before they are saved As an alternative to faxing CRFs can be scanned to a PDF file and then transmitted to a DataFax server as described below When the server receives the PDF it is processed just like an incoming fax Thus the pages will not appear in patient binders until they have been reviewed and entered by a user with permis sion to use Fax View 60 4 14 Transmitting Scanned CRFs Note DataFax also supports emailing a PDF attachment to datafax your_server_name but unlike email PDFs transmitted to the server by iDataFax are encrypted using SSL and are thus secure 1 CRFs must be scanned in Black amp White and saved as a PDF file The current version of DataFax does not support color or grey scale There is no practical limit on the number of pages that can be included but of course the time required to transmit the file to the DataFax server will increase with its size 2 Start iDataFax and login to the destination DataFax server Since a PDF is processed just like an incoming fax it doesn t matter which study you are using when you transmit a PDF and the PDF can even contain CRF pages for multiple studies as long as all pages in the PDF file are for studies that reside on that DataFax server m Note If you use different DataFax servers for different studies make sure you select the correct server Transmitting a PDF to the wrong DataFax server would be the same as sendin
155. one field containing an l dbe ttt investigator name Haynes Brian Hill Bradford Osler William Pasteur Louis Salk Jonas Sackett David OK f Cancel Apart from it s simpler structure this lookup table behaves exactly the same as the MedDRA lookup table described above 4 11 Query Management Queries can be created modified and deleted by edit checks with no user intervention or manually by selecting Add Query Edit Query or Delete Query from the Field menu to invoke the query dialog illus trated below 4 11 Query Management Page Edit Query lanes 7 iDataFax Edit Query Site 1 Patient 1002 Assessment Baseline Page Patient Entry 07 01 06 Field Pulse beats minute Reported Value 044 Problem Illegal i Use External is Status New query Type Correction E Details Please confirm this very low value Note Created dwt November 26 2008 14 50 32 Modified dwt November 26 2008 14 50 32 The query dialog has the following components e Title The title at the top of the dialog shows the information needed to identify which patient and study form the query is about e Field The field description as entered in the study setup identifies the data field in question e Reported Value When a new query is create this field shows the value currently recorded in the data window but this can be changed by the user For example if a date is uncle
156. ons will typically include a adverse event records plate 9 description of the record selection at level 2 data entry reviews completed criteria what the user needs to do with status Final no remaining problems with each task record and what happens when a task record is Task Result saved saved records are moved to work flow level 3 13 data records match the search criteria Selecting OK will retrieve the records that met the task criteria The record list will include only those sites patients and visits that contain task records If user preference open first task record when a task set is built is on the first task record will open automatically otherwise a patient binder must be selected to display the task records Task Records 1001 1 of 3 task records amp Boston General The title shows the current patient ID and the 7 1001 current task record and number of task records Y 1 Adverse Event Log 01 for this patient mane e 0l v Adverse CIO LAA 02 1 The square icon in the title toggles between the 1 AE Log Page 02 standard patient binder list shown here and a 1 Adverse Event Log 03 simple list of task records v AE Log Page 03 Eal k rae Task records are flagged with the letter T which 7 1003 changes to lower case t when the record is TE 1004 saved The current t T record counts are 1H 1006 displayed at the bottom of the iDataFax window TE 1008 no
157. onths and 3 Click on the assessment in the patient binder list missing this follow up visit 4 Select Assessment gt Mark Assessment Lost This opens the dialog shown here After you select the reason category Why and explain sme Cancel why the assessment is lost Details the Save eo eee button will become active When you click Save all of the pages in the assessment will be marked lost and the lost symbol L will appear in the assessment and page list on the left side of the screen Whenever a lost record is selected the reason specified when the assessment was marked lost will appear in the Reason window in the bottom left corner of the iDataFax window If an overdue visit query exists it will be removed when the assessment is marked lost Once an assessment has been marked Lost data entry will be blocked for all pages in the assessment If you discover that it was a mistake to mark an assessment lost select the assessment in the record list and then select Unmark Lost from the Assessment menu This will remove the Lost flag and enable data entry for all pages in the assesment It is also possible to remove the Lost flag from individual pages by select ing the page and then selecting Unmark Lost from the Page menu 27 iDataFax User Guide 3 12 Can I indicate that a page is unavailable Yes A single page within an assessment might be unavailable while other pages can be completed This might aris
158. ords to the current task set This can be repeated as needed to build a task set Select Search aca iDataFax Search Data Fields Field 8 24 Value v illegal _ missing blank required or _ equals _ contains or Query _ pending _ outstanding __ resolved and _ external __ internal and contains or Reason _ pending _ rejected _ approved and contains Data Records Status _ final __ incomplete _ pending _ lost Site 35 Patient ID Assessment Level 2 7 Creation Modification Expression _ By Program Direction J Up Down _ Match case wv Filter New Task Done 90 In this example the current record list will be filtered to show only those records for which fields 8 24 are illegal or blank but required site is 35 and work flow level is 2 7 After specifying the search criteria click the Filter button to start the search A dialog will appear showing the number of records that meet the search criteria and asking for confirma tion before filtering the record list to display only these records Note to be selected records must meet one or more of the criteria specified in the Data Fields section and all of the criteria specified in the Data Records section 8 6 Searching Data Records To undo a Filter and display all data records for the current plate select All Records from the Show menu To undo a Task and remove the T icon from all records select All Records from t
159. ore opening the new page The Save options include e Final use this option if all fields have been completed or explained with reasons all queries have been answered and you know of no other changes that are needed to complete data entry A green check mark will appear in the page icon e Incomplete use this option if any field is still incomplete or any query is still outstanding A red X will appear in the page icon e Pending use this option if you are not finished with the page and want to work on it some more before it is reviewed by the study coordinating center A yellow dash will appear in the page icon There are two restrictions 1 Pending will not be available once a page has reached Final or Incomplete status if your permissions only allow Pending to be used during new data entry If this is the case the Pending button will be inactive to prevent a mistake 2 Final can not be used if there are any red or blue fields on the page i e any problem fields which have not been corrected or addressed using one of the 3 metatdata options i e replying to a query 28 3 14 Can undo all changes have just made to a page adding a new reason or assigning a missing value code In this situation the Final button will be inac tive When a Patient is Locked Save 5 Patient 1002 locked by another user Last Save May 11 2006 4 53 45 PM iDataFax uses patient level locking which ensures that only one user can wo
160. ormation from the study coordinating center A query can be up to 500 characters long and has a status of outstanding the query still needs to be addressed O pending the query has been addressed but the solution has not yet been reviewed by the study coordinating center resolved the query has been addressed and the solution has been accepted by the study coor dinating center You can reply to a query by clicking the button on the Query window or selecting Field gt Reply to Query and entering up to 500 characters of text When a reply is entered the Query status will change to Pending Some queries do not require a reply and can be resolved simply by correcting the data field A blank field with problem type missing or an illegal field with problem type illegal can be resolved by enter ing a legal value 34 4 3 Data Field Colors If a query requests a data correction which cannot be made because the current value is correct you can respond either by replying to the query or adding a reason to explain the current value e Reason reasons can be entered to explain unusual data values by clicking the button on the Reason window A dialog will appear where you can type a reason 500 characters maximum or select one of the standard reasons defined for the study For example if a field turns red because the value you have entered is considered illegal you could add a reason to explain the value which might be en
161. ough to avoid receiving a query from the study coordinating center When you add a new reason or change an existing one the field will turn orange with status pending to signal that it should be revewed by the study coordinating center If you change a field which already has a reason you will be required to provide a new reason explain ing why the value has been changed This ensures that the reason displayed is always related to the current value e Missing Value if the study has been configured to use one or more predefined reasons explaining why a field may be missing you can select one of these reasons using the button on the Missing Value window and keyboard shortcut Control M Command M on Mac OS X can be used to apply the most recently used missing value code to a new field However a missing value can not be assigned to fields defined by the study coordinator as essential 4 3 Data Field Colors Colors indicate the status of data fields and whether they have associated metadata queries reasons and or missing values The colors used for fields without metadata are e White legal values e Red illegal values or blank required fields e Yellow blank optional fields The colors used for fields with metadata are e Blue fields with outstanding metadata an unresolved query or a rejected reason e Orange fields with pending metadata a reason or query reply that has not yet been reviewed by the coordinating center
162. ously entered record to review or modify it But remember that it is possible to discover that another user has modified or even deleted the record since you last saved it 7 7 Fax View Menus This section describes the options available under the menu labels Select and Page which appear at the top of the screen Only those options which are unique to Fax View are included All other menus and options are the same as already described for Data View 85 iDataFax User Guide 7 7 1 The Select Menu The Select menu is used to select pages from the new record queue for data entry The options include Automatic Retrieval as described above this dialog is used to specify how records are assembled for data entry Manual Retrieval use this option to display the list of records awaiting data entry and manually select those you want to enter next Raw Data Entry use this option to build a set of blank records for data entry from hardcopy CRF pages held outside of DataFax By Task this option allows users to select a predefined new data entry task Define Task use this option to specify a task for new data entry including record selection rules grant users roles permission to use the task user instructions etc Next Set this option applies the current record retrieval specifications to assemble the next set of records for new data entry Previous Set this option allows users to return to the previous set of records but only
163. owing e From the top button on the right select New View then enter a name and description e select the plate and data fields in the desired order If no fields are specified all fields in plate order will be used e select list view options These will override the users Preference settings for List View when the view is selected e specify the roles and logins to identify those who can use the view and those who own and thus can change it e specify the record selection criteria If none are specified all data records for the plate will be retrieved when the task is selected e if you want the selected records to form a new task set check the new task option and specify the task mode level and whether edit checks are to be executed if the user switches to Data View to review and perhaps modify a data record If the new task option is selected any previous task will be cancelled when the user selects the view 95 iDataFax User Guide Select Define Views A iDataFax Define Ellview NamelMeaical History SSS Description review cases with missing or illegal values itststi lt is s S S Plate 003 Medical History Field List 7 79 Field Name generic unique number name Coded Field code label Date Field default calandar julian _ apply imputation rule User Roles QC Manager Logins dwt Owner Roles B Logins dwt Created dwt December 16 2008 16 13 20 Modified dwt Dec
164. page will become the current page displayed in the router window and the bottom half will become the next page In very rare cases you might see the following error message error Unable to add new image This indicates that the image can not be found in SDATAFAX_DIR work fax_log idx the faxlog index file If you encounter this message contact you DataFax system administrator for assistance If the faxlog is complete and the only problem is the index file it can be regenerated but if the faxlog is not complete the audit trail will need to be searched to locate the relevant fax discover the last page number and create a new fax log entry before reindexing the faxlog Warning The Cut action can not be undone 120 11 6 5 Truncate Length 11 6 5 Truncate Length The size of the page width x length in pixels is shown in square brackets at the bottom of the screen After a CRF has been shifted to the top of the page signature line it should not be longer than 10 5 inches The resolution of each page is 100 pixels per inch Thus a length greater than 1050 pixels indicates that the page is too long In such cases you should examine the bottom of the page to see if it just contains fax noise If it does select Truncate Length from the Page menu to remove the excess length If you make a mistake select Reset from the Page menu to undo the gt Truncate Length operation 11 6 6 Trim Width Fax machines that can accommodate page
165. patient binder can be open at a time opening a new one will automati cally close the open one if any When you are finished entering data for all patients logout by selecting Exit from the File menu in the menubar Chapter 2 A Guided Tour Chapter 2 A Guided Tour DataFax includes 3 separate internet tools DFsystem for user and study administration DFsetup for creating new study databases and iDataFax for study data management This chapter provides a brief introduction to iDataFax It begins with a description of how to login to a DataFax study server and then describes each of the major components available under the View menu 2 1 Login To work in a study database you must first start iDataFax and login to the DataFax server where the study data and configuration information are stored This requires an internet connection The study coordinating center will have provided you with the iDataFax program Windows and Apple OS X versions are available the name of the DataFax server your login name your initial password and the name of the study or studies which you have permission to access on this server There are 2 steps to the login process as illustrated below In the iDataFax the The Login Dialo aie g g login dialog enter the ANA j z7 server name login iQ OQO aE Daaa Data Mana gament cl name and password and then select the iDataF ax Version 4 1 0 Login button DataFax Server idemo41 datafax com
166. pear in the bottom right corner of the screen Depending on your user preference settings see below you may need to click the image icon to toggle between data and image views or the screen may split automatically when you go to a page with images If multiple images exist the image icon will be prefixed with another icon containing the number of iDataFax User Guide images Clicking this icon will launch a separate window where you can review all of the images e Menus A number of menus are located at the top of the iDataFax window The example screen at the beginning of this tour illustrates the View menu which is used to switch between the different views that you have permission to use in the current study These menus differ by view and are described in the chapter devoted to each view e User Preferences You can customize some aspects of iDataFax behavior using the Preferences dialog located under the File menu Once set preferences are preserved across login sessions e Auto Logout To meet regulatory and patient confidentiality requirements iDataFax was designed with an auto logout feature which closes the screen after a specified period of inactivity If this occurs when you have unsaved changes in the current data screen the unsaved changes will be lost and you will be warned that this occurred the next time you login to the study and asked if you would like to return to the page you were on when this happened You can thus easily retur
167. per Data fields are color coded as follows white legal values red illegal values blue unresolved queries orange query replies and reasons pending central review ooo 10 2 3 Data View green query replies and reasons that have been approved Queries Data queries can be attched to any data field either by someone in the study coordinating center or by a programmed edit check Blue fields have an outstanding query which will be displayed in the Query window lower left when you select the field in the Data window Queries for missing data and illegal values are automatically resolved and turn green if they are corrected by entering a legal value The button in the Query window can be used to open a text window where you can answer the query This turns the data field orange to indicate that the query has been answered and is pending review by the study coordinating center If the reply is approved the field will turn green If the coordinating center has new questions they will revise the query and the field will again turn blue Reasons You may be able to avoid queries my entering a reason to explain an unusual data value To add a reason to a data field select the field in the data window and then click the button in the Reason window lower left to open a text window where your reason can be typed Fields with new reasons will turn orange to indicate they are pending review by the study coordinating center If the
168. pes Missing the field is blank and needs to be completed Illegal the field failed the legal range test Inconsistent the field contains a value that is inconsistent with the value in some other field Illegible a paper CRF page has handwriting which is unclear Fax noise a faxed page had transmission errors Other some other problem described in the query details In some cases such as when the problem type is Missing or Illegal no further information may be needed to communicate the problem But when necessary the query will include details describing the problem and might also suggest the expected corrective action If a query is attached to a data field it will be displayed in the Query metadata window when the focus moves to that field in the data window If the query is not yet resolved the field will be blue and the query status will be Outstanding If the query has been resolved the field will be green unless there is another problem like a rejected reason and the query status will be Resolved 24 3 7 How do find all outstanding queries 3 7 How do find all outstanding queries iDatafax File view EEUE uev Heip F eee All Queries emo Study May 12 2006 and May 18 2006 Site Patient Assessment Resolved Queries Status amp Replies site 1 General Hospital Pending Queries x 1002 Baseline 18 illegal Outstanding dwt May 11 2006 2 31 51 PM Overdue Visit Queries Fand 06 months and c
169. played at the EA ao AAE EA top of Record Retrieval dialog each Sign off Level 1 PS time it is opened In this example there are 69 CRF pages awaiting data entry of which 3 are currently locked by other New queue contains 69 pages 3 in use F Enable Edit Checks Select faxes Q Pages Plates users By Age Oldest O Newest We recommend selecting a fax at a Quantity 1 faxes time and processing the oldest faxes first but it is possible to select a speci FA Repeat fied number of pages to only enter specified CRF plates or to enter the on 4 Cancel most recent arrivals first e_ lllalllalalalalalalalalalalalalalalalllllMlalalaialaaasssssSMlSS 80 7 1 The Record Selection Dialog Raw Data Entry is used to build a specified set of blank data entry screens for data entry from hardcopy residing outside the DataFax system Some or all of the keys may be specified If patient IDs alone are specified a complete CRF book as defined in the study visit map consisting of all required and optional visits and all required optional and missed visit plates will be created for each specified patient ID A maximum of 999 patient IDs and 10 000 data records can be included in each Raw Data Entry set If patient ID is not specified the user must indi cate the number of cases to be created If data entry is interupted only those records that have been saved to the database will exist in the database
170. port created by DF_ATmods Note permission to use this option is typically tightly controlled Mark Page Lost if a page is unavailable this option can be used to mark it lost In the dialog which appears you must select one of the standard reasons or other additional details explaining why the page was lost can be entered in this dialog 68 4 16 8 Field Menu A page that is marked lost can not contain data Thus pages that have already been saved can not be marked lost unless the data record is first deleted Also if data has been entered into data fields on a new record before it is marked lost the data fields will be cleared when marking it Lost is confirmed After a page is marked lost all data fields become inactive to prevent data entry If a missing page query exists it will be removed when the page is marked lost Study managers may add a query to the patient ID of Lost records to request additional information from the clinical site Unmark Page Lost this undoes the previous option removes any data query that might have been added to the patient ID field and enables data entry Context use this option to display the date and time the CRF page arrived if one exists and where it came from if a source identifier was programmed into the transmitting fax machine Show Field Properties this option displays key properties of all fields defined on the current page including name description style need type
171. r fields and clicking the Update button e Links You can jump to the data query or reason records for any cell in the tables by double clicking the cell 18 Chapter 3 Using iDataFax Chapter 3 Using iDataFax This chapter explains how to perform a number of common data management tasks It describes what is possible in iDataFax but how these features are applied may differ from one study to another You may receive more specific instructions from the coordinating center for your particular study 3 1 How do I select the correct patient binder for a new patient In many studies patients are numbered sequentially as they enter the trial but in some studies patient ID numbers are random and assigned on study enrollment or randomization In either case patient IDs must be registered in the DataFax study setup at the coordinating center before they will be available in iDataFax The Patient Binder List To see the patient binders available for your site select View gt Data If you work at more than one Bsite 1 General Hospital 1001 study site you will need to double click on a site H 1002 to open it You will then see a list of patient 1003 binders identified by head icons and patient ID 1004 numbers in ascending numeric order on the left 1005 side of the screen Binders that are in use are ioe p o O represented by an active icon Unused binders Li appear muted with an empty head icon In most x
172. rd is loaded _ when the revised record is saved za Screen Options Background color black O white color Background type Default B E Auto Logout Exit after 10 minutes of inactivity 125 NTE YT Chapter 12 User Preferences Select Preferences from the File menu to view and change your iDataFax preferences Preferences are user and study specific The default settings are illustrated here Any changes are applied immediately and preserved across sessions Some prefer ences may refer to parts of iDataFax for which you do not have permission and will thus be irrelevant A description of each of the preference settings appears below iDataFax User Guide 12 1 Data Window expand all assessments when a patient binder is opened if this preference is not checked patient binders will open to show all study assessments but all assessments will be closed whereas with this preference checked all assessments are also opened to show the CRF pages they contain display first page when an assessment is opened this preference determines whether the data screen is automatically loaded with the first page of the assessment when a new assessment is opened advance to next field after current field is completed if this preference is not selected the focus remains on each field until the user presses the Tab or Return key to advance to the next data field open first task record when task set is built
173. records For example when searching for records at level 1 you will get different results depending on whether you are searching for level 1 in data query or reason records In addition to the record selection criteria this dialog requires specification of the Mode and Sign off Level These setting apply to both data and metadata records It is important to remember that the modes do not grant any permissions that the user does not already have Permission to view and modify data and metadata are controlled by study roles defined and assigned to users by the study management team Thus you will only be able to select records you are allowed to see and regardless of the mode you select you will only be able to modify data and metadata for which you have modify permission 51 iDataFax User Guide When the user selects Done a dialog will appear indicating the number of records in the database that match the selection criteria The user can then select OK to proceed or Cancel to abort the selection If the user decides to proceed the record list is reduced to show only those sites patients and assess ments that contain records in the adhoc task set and each of these levels is flagged with a T icon Just as with predefined tasks the T icon changes to t when a task record is saved This shows that the record has been reviewed but does not necessarily mean that the task has been completed as intended If the record still meets the
174. rk in a patient binder at a time The binder is locked when you open it and released when you close it It will also be released if your iDataFax session times out If you try to open a patient binder which is locked by another user a dialog will appear asking if you want to open it in view only mode While in view only mode the Save buttons will be inactive and a message indicating that the patient is locked by another user will be displayed at the bottom of the Data window Even if you are the only person with permission to enter data into patient binders at you site remember that someone at the study coordinating center will have permission to review and approve or reject new reasons for data values and replies to queries that you have entered This too will lock a patient binder until the review is completed typcially only a few minutes 3 14 Can undo all changes I have just made to a page Yes but only if you have not yet selected one of the save buttons Select Page gt Revert to Last Save to undo all changes to data fields and metadata queries reasons and missing values and return the page to the state it was in when you opened it This is the only undo level available Once you have selected one of the Save buttons Final Incomplete or Pending you can not revert to a previous state 3 15 What s the best way to find all outstanding problems Start by reducing the patient binder list to just those patients that have In
175. rrently available or off line for mainte nance If a study is available double clicking the study name will open the study database 1 13 After connect to a study how do enter patient data If you are not already in the Data view select it from the View menu in the menubar The clinical sites in which you have permission to work will then be listed on the left side of the screen Double clicking a site will open it to reveal the list of patient binders Double clicking a patient binder will open it to reveal the study assessment tabs and double clicking a tab will open the assessment to reveal the data entry pages for that assessment You can then enter data add reasons to explain unusual values and reply to outstanding queries from central office iDataFax User Guide When you are finished with a page to save your work in the study database at coordinating center click one of 3 Save buttons at the bottom of the data entry window Final to indicate that data entry is complete incomplete to indicate that some fields are incomplete or some queries remain to be answered or Pending to indicate that you have not yet finished your first pass through the page and want to finish it before it is reviewed by the study coordinating center 1 14 What do I do when I m finished entering patient data You can close an assessment by double clicking the open assessment tab and close a patient by double clicking the patient icon Only one
176. rt all reports History list DF_CTvisits 5 0 1 21 24 The individual reports and report options are displayed for the selected list All reports can be executed in the order they appear in the list by selecting Run all reports and then click ing OK The output from each report will be added to the current History list When the last report finishes the History section of Report View will open so that the output from each report can be reviewed Alternatively reports can be executed one at a time by selecting the selected report option slecting a report from the list and then clicking OK stiB iDataFax User Guide Chapter 10 The Status View 10 1 Introduction The Status View provides a quick overview of the status of the study database and shows a list of users who are currently working on the study It can also be used to quickly assemble a set of records to perform some task by double clicking on any cell in any of the 3 tables Figure 10 1 View Status 114 Pages awaiting review in the Unidentified Fax Router 3 _ linctudes pages for all studies Pages awaiting review in the Study New Fax Queue 4 _ inctudes 0 pages in use iDataFax dwt localhost demo253 Status 10 2 Level amp Status Site Update Patient Yi Caws Assessment lt naam Page S Data Records Queries Reasons Level Pending Lost incomp Final Total Pending Unres Resid Total Pending Rejetd
177. run DataFax standard and study specific reports iDataFax File Edit Select Help Boo fax xF p fax com DEMO 2 ports DataFax Reports Data D Index to Standard DataFax Reports Queries Q Reasons R 5 DF_ATcrts Renort ae DF_AT faxes DF_ATmods Status 5 DF_CTerts List L DF_CTpages s DF_CTacs Run Explain Font Report DF_INDEX 76 lines Clear DF_CT visits DF_ICcenters Quality Control P DF_ICimages DE ick DP_QCfax Fax or email QC reports OP_QCfaxlog Examine the status of faxed emailed QC reports DF_ICqes DF_QCprint Print QC reports DF_ICrecords DF_Qcreports Create QC reports DF_iCschema bF_ocsent Mark QC reports as sent F i DF_QCstatus gt List existing QC reports maianen DF_OCupdate Update QC database Cvisitmap DF ocview 2 Display requested QC reports DOF_PTerts DF_PTlist Patient Tracking DF_PTmissing ee DF_PTacs DE _PTerfa Display available CAF information for patients i DF_PTlist List patient data grouped by patient id and visit number DF_PTschedule DF_PTmissing Display missing pages and overdue visits DF_PTunexpected DF_PTqes Summary report of external QC notes for each patient DF PT visits OF_PTschedule Display patient scheduling information from OF QCreports DF QCfax DF_PTunexpected List unexpected data records found in the study database DF_QCfaxlog OF_PTvisits Scheduling and status of all cycles amp visits in the visit map DF_QCprint Center Track
178. ry and reason changes are saved the status of the data record will also change to Incomplete if needed to signify that it contains one or more outstanding prob lems On the other hand approving all of the query and reason replies on a data record does not automat ically make it Final but does enable the Final save button which can be selected if you want to change the data record to status Final The Review Approve dialog allows you to perform work flow management on the metadata independently of the data records When you have completed your review of the metadata on a page you can proceed to the next page in the task set You do not need to save the data record itself unless you have made changes to data fields that you want to keep or you want to change the data record status and or level The work flow level will only be changed on data and meta data records that you save The following example illustrates the Review dialog for a data record which has 2 queries and 3 reasons attached to 4 data fields The data field and the current work flow level and status of each associated query and reason is shown in the list at the top of the dialog 59 iDataFax User Guide Field Review Queries and Reasons iDataFax Review Queries and Reasons Site 4 Patient 14003 Assessment Baseline Page Patient Entry 20 06 01 Field Query Reason Eligibility Explain _3 External Outstanding Date of Birth _1 Extern
179. s DF_QCfaxlog Examine the status of faxed emailed QC reports DF_iCacs DF_Qcprint Print QC reports DF_ICrecords DF_Qcreports Create QC reports DF_iCschema bF_ocsent Mark QC reports as sent DF_QCstatus List existing QC reports iphone DF_QCupdate Update QC database Rvistimap pF_ocview Display requested QC reports DF_PTcrfs DF_PTlist Patient Tracking DF_PTmissing en p DF PTacs b _PTerfa Display available CAF information for patients ta DF_PTlist List patient data grouped by patient id and visit number DF_PTschedule DF_PTmissing Display missing pages and overdue visits DF_PTunexpected DF_Piqes Summary report of external Qc notes for each patient DF PT visits OF _PTschedule Display patient scheduling information from DF_Qcreports DF QCfax DF_PTunexpected List unexpected data records found in the study database DE QCfaxlog DF_PTvisits Scheduling and status of all cycles amp visits in the visit map DOF_QCprint Center Tracking DF_QCreports DF OCsent DF_CTerts 3 Summary report of records received from each center DF br _cTpages Summary report of CRF pages received by fax and or email QCstatus DP_CTqcs Summary report of external Qc notes for each center DF_QCupdate DF _CTvisits Bumber of patients who have reached each visit at each center DF_QCview DF_SScenters Andit Trail DF_SSschema OF_ATerts Track keys associated with a CRF page over time DF_SSvars DF_ATf axes Trace validation history of each page in selecte
180. s described for the previous option The assignment will be displayed in the results dialog illustrated below iDataFax import Patient Documents iDataFax Import for Study DEMO 253 started on November 9 2010 21 30 06 by jack idemo4 datafax com Pile Users jack ScannedPiles DemoStudyLetters pdf Task Attach each page to the data record identified Results 3 pages selected 3 pages imported Import log Id Visit Plate Image Import Message 1001 12 2 1045 0011001 imported as secondary image 1004 1 3 104570011002 imported as primary image 1002 101 9 1045 0011003 imported as primary image End of Import November 9 2010 21 30 07 OK Prin Save If a page is imported for a data record that does not currently exist in the study database a pending data record will be created and added to the patient binder e Import data entry worksheets CRFs identified below Use this option if you want to import worksheets or CRFs on which data has been recorded and then use DataFax s split screen data image feature to enter the data into the corresponding data records This option begins like the previous one the pages to be imported are identified and selected the import button is clicked and the user is prompted to enter their password after which the selected pages are imported and the results dialog appears It differs from the previous option as follows Only one page can be imported for each data record If the same
181. s enter them in the Search Terms widget at the top of the dialog check the option to find entries that contain ANY or ALL of the terms check the fields to be searched and then click Find or Filter Find displays the next matching row while Filter reduces the table to display all matching rows After reducing the rows to a filtered set you can enter new search terms and search or filter again within the current rows Select Reset to display all rows in the lookup table When you have found the correct row either double click it or single click it and then click OK This will return your selection to the edit check and put the lookup table away What happens next depends on what the edit check is programmed to do Typically all or some of the fields from the row you selected will be entered into specified data fields on the current page but the edit check may be programmed to do something else 55 iDataFax User Guide If each row in a lookup table has only one field a simpler dialog will appear without the top field display section An example appears below Lookup Table Example 2 iDataFax DFlookup investigators Search Terms Hill find entries with ANY ALL of the search terms in the following fields Find Previous Filter Reset Banting Frederick Barnett Henry This example shows a Cochrane Archie simple lookup table in Fleming Alexander which each TOW has just TES EID
182. s wider than 8 5 inches require their paper guides set to 8 5 inches for proper scanning of letter size pages If the guides are set too wide the paper can tilt or shift resulting in skewed or abnormally wide images When pages like this are received they generally appear in the router because they are wider than the 864 pixel maximum To route a wide page you can trim the width of a page by selecting Trim Width from the Page menu Two dashed vertical lines appear over the document spaced 864 pixels apart Using the mouse position the lines over the area of the page you want to preserve Click the left mouse button to discard the page area which lies outside these two lines or click the right mouse button to cancel the operation If you make a mistake select gt Reset from the Page menu to undo the gt Trim Width operation 11 6 7 Rotate 90 CW CCW You can rotate a page 90 clockwise by selecting Rotate 90 CW or counter clockwise by selecting Rotate 90 CCW from the Page menu Each time you select this menu option the current page is rotated 90 in the specified direction This is useful when a sender faxes a page to you sideways and you want to put it into a portrait orientation If you make a mistake select gt Reset from the Page menu to undo all operations on the page or rotate the page in the opposite direction to return it to it s previous orientation 11 6 8 Rotate 90 CW CCW and scale It is possible to process landscap
183. sage create a new QC note or edit an existing one ata modify a data field he default value for the which opiton is msg qc data i e all 3 triggers apply he which option applies to all batches Only 1 which option can be specified tatus can be specified using 3 7 or 3 8 terminology like this s clean dirty error lost or s final incomplete pending lost Temporary files are created in the study work directory and then removed 8 User permissions are applied N U Cid OQ re or EE I EXAMPLES Write DRF records to standard out for study 253 if edit check testl or test2 on plates 1 3 would display a message add or modify a query or make any changes to a data field DFmkdrf ec 253 P 1 3 E testl test2 Same as the first example but only trigger these edit checks on plate 1 and only for data records that have status final and are at validation levels 3 6 DFmkdrf ec 253 P 1 E testl test2 s final v 3 6 Same as previous example but trigger testl on all plate 1 records and test2 on plate 2 3 records that have status final and are at validation levels 3 6 DFmkdrf ec 253 P 1 E test1 P 2 3 E test2 s final v 3 6 Same as the previous example but edit checks test1 and test2 only generate a DRF record if they would have created a new QC note or modified an existing QC note DFmkdrf ec 253 P 1 E testl P 2 3 E test2 s final v 3 6 which qe Create DRF records for any edit check that would change a data fi
184. selected To enenable data entry on a page the Lost flag must be removed see below If an overdue visit query exists it will be removed when the assessment is marked lost Unmark Assessment Lost this undoes the previous option if the default dialog was used If a special missed visit report page has been completed it will remain in the study database just like any other study record unless it is deleted 4 16 7 Page Menu The Page menu provides the following options for the current page Save offers the same 3 options provided by the save buttons at the bottom of the window Final Incomplete and Pending Revert to Last Save erases all unsaved changes that have been made to the current page Review Images displays all images primary plus all secondaries and allows user to select which image to call primary delete secondary images and correct keys on secondary images Change Keys this option allows you to correct any errors in the key fields that might have occurred when a page was saved including corrections to the study number patient ID number assessment number and page number Delete This Page this option is used to delete a data record When this is done all of the data queries reasons and images associated with the record are deleted A confirmation dialog is displayed and a reason can be entered to explain why the record is being deleted Both the delete action and the reason will appear in the audit trail re
185. selection criteria for the task it will come up again the next time the task is performed All other sites patients assessments and records are hidden but can be revealed by selecting the button labeled Show All Records for This Patient at the bottom of the record list 1001 1 of 2 selected Site 1 Boston General Y ra fi 1001 v 10 Screening Visits To toggle the current patient between task J1 Form 101 01 06 records and all records use the button at the Y 1 Baseline bottom of the record list labeled Show All 1iX 2 Form 2 Records for This Patient T 1002 re 1003 The entire record list containing all sites and Tif 1004 patients can be toggled using the menu items Site 2 Vancouver Health Care I Show All Records and Show Task Records Site 3 Hamilton General Hospital Show All Records for This Patient 4 9 3 Select By Data Retrieval File This option can be used to retrieve data records listed in a DataFax Data Retrieval File DRF These files must have a drf extension They can be loaded from either the study drf folder or the users local PC DRF files can be created by standard DataFax reports like the example shown below by saving a current task set using File Save DataFax Retrieval File by using DFmkdrf jn or DFmkdrf ec described in the Appendinx or with a custom program To retrieve records listed in a DRF choose Select By Data Retrieval File to launch the dialog shown below
186. ser Guide Note lf you process more than one image for the same data record in the same session the last image saved will become the primary image and the previous ones will become secondary The split screen in fax view shows only the current data record primary image Thus returning to a secondary image in the fax view record list will display the image but not the data record This helps to ensure that users realize they are looking at a secondary image which has been superceded by another image in the record list If after loading the existing data record you discover that you have made a mistake select Page Revert to Initial State to undo all changes to the current record 7 4 Correcting the Keys Each new page has 4 keys which together uniquely identify it the DataFax study number plate number visit assessment number and patient ID number The study and plate numbers are always in the bar code the visit number can appear either in the bar code or as the first data field on the page and the patient ID always appears as the first data field following the visit number It is critical that these keys are correct and they should be carefully checked before a new record is saved to the study database If ICR has misread a patient ID or visit number data field they can be corrected by modifying the data field but to correct those keys that appear in the bar code you need to select Change Bar Code from the Page menu and use the dialog illus
187. ser Guide Preface Images in this document are screen shots from iDataFax running under Mac OS X However functionality is identical under all operating systems and images are almost identical except for window decorations Instructions to select some object can be carried out either by clicking on the object using the mouse or by keyboarding to it and pressing the space or Return key Instructions to select Menu gt Option refer to the selection of options from the menus at the top of the screen For example to open the Data window select View gt Data The instructions contained in this User Guide are intended to describe in general terms how data entry is performed using iDataFax The guidance provided here is not meant to replace more specific instructions which may be provided by the sponsor principal investigator or coordinating center for a particular trial Chapter 1 Introduction Chapter 1 Introduction 1 1 What is iDataFax iDataFax is a computer program used to enter review and modify patient data and to submit it over the internet to a DataFax server at the study coordinating center This type of data entry is commonly referred to as Electronic Data Capture or EDC iDataFax is part of the DataFax clinical trial management system which also supports data collection by fax Both methods can be used in the same study but EDC has often been described as having the advantage of providing immediate help to users resul
188. sk use Select All Records to put the task set away remove the T and t icons from task records and resume access to all patient binders and data records 4 8 2 Defining Tasks Users with permission can define tasks for themselves and other users using the task definition dialog illustrated below Only one user can define tasks at a time but other users can open this dialog in view only mode Select Define Tasks iDatafax Define Tasks Task name description and instructions document what the task is about Task DDE from faxed CRFs Description double data entry Instructions Objective correct any errors made during new data entry 0 User Roles and Logins identify who is allowed to perform the task Record Selection Criteria faxed CRF pages data records with images Owner Roles and Logins identify who is saved with status final or incomplete i err at levet 1 allowed to modify the task definition In by other users addition study administrators have permission to modify all tasks User Roles Data Entry Logins Select a mode the level you want Owner Roles records moved to when they are saved Logins dwt oo and whether you want edit checks Created dwt January 9 2008 22 50 51 enabled or disabled while performing the Modified dwt March 11 2008 16 09 37 task a a 2 The final section closed in this example Sign off Level 2 BY E Enable edit checks is for the record retrieval specifications Search lt
189. ssessment 1 Page 3 ID number Assessment number and Page The changes on this page have been lost number and you will be able to return to it by Do you want to return to this page clicking Yes Note If you return to a page after some time has passed and other users are authorized to modify the page some data fields may have been changed since you last saw it You can tell if this has occurred by comparing the time shown in the Auto Logout dialog with the Last Save time displayed at the bottom of the Data window when you return to the page sois iDataFax User Guide 3 17 How should I exit from iDataFax First make sure that you have saved any changes to the page you are currently working on If you forget you will be warned when you try to exit When you are finished working in a study you can close the study or quit the entire iDataFax session e To close the study but remain connected to the DataFax server so you can select a different study database to work in select File gt Close Study This will take you back to the same study selection window that appears during login e To disconnect from the DataFax server and end your current iDataFax session select File gt Exit 3 18 What should I do if have questions First attempt to find an answer within the online User Guide available under the Help menu in the menubar If this fails contact the study coordinating center for assistance 399 Chapter 4 The Data Vie
190. st ones first but it is possible to request only certain CRF forms and to work backwards from newest to oldest arrivals These options are specified using the New Record Retrieval Dialog available under the Select menu e Intelligent Character Recognition When a CRF page arrives by fax it is immediately scanned and read by the ICR software Thus most data fields including numbers dates visual analog scales and check boxes will already be completed in the data screen The task of the person using Fax View is thus to correct any ICR errors or omissions and to add any missing value codes reasons or queries that may be required 14 2 7 Reports View e Get Next Set of New Records When the user is finished with the current set of records clicking this button located below the record list will release the current set of records and fetch the next set using the selection method previously specified in the New Record Selection Dialog But until then the user can return to any record in the current set to make corrections which sometimes become apparent as one works throught the pages in a fax Switch to Data View Clicking this button opens the current patient binder in Data View while keeping the focus on the current page to show where it belongs in the binder The user can then check other data records as needed before switching back to Fax View to complete data entry for the new page 2 Reports View The Reports View is used to
191. t Page Field Help Te OO iDataFax jack localhost Demo Study 1002 3 of 18 Duration Years amp Months ES Site 1 General Hospital v 1002 1 Hypertension gt 0 Screening Visits v X 1 Baseline V 2 Patient Entry F 2 Atrial Fibrilaton 3 Medical His 4 gt Current Medica 3 gt 21 1 Month Follow up 3 Other Cardiac EG Arrhythmia As shown below in addition to looking for the red and blue fields it is possible to get a list of all outstand ing problems on the current page ana DataFax Outstanding Problems Field L Mypertension Duratn Mon 16 Problem Value is illegal Details Legal values are 0 12 Site 1 ID 1002 Assessment Baseline Page Medical History To list all problems on the current page select as tan esa anata Page gt List All Outstanding Problems on This Details Pease change to 01 years and 06 months and complete Page all durations in this way Thank you Status Outstanding OK 3 16 Why did my iDataFax session Auto Logout For regulatory reasons related to confidentiality of patient data and the requirement that data entry must be attributable to an authorized individual user you must exit iDataFax as soon as you are finished with it or when you need to leave the computer unattended for any reason Should an unexpected event or emergency prevent you from logging out a built in timer will automatically log you out after a specified period of inactivity de
192. t and page icons use the same colors with the same meaning but they come in different shapes to indicate whether they are required e Square a required assessment or page e Circle an optional assessment or page which may not be relevant for all patients e Diamond an unexpected assessment or page A square button at the top of the navigation panel can be used to toggle between patient binder and record list navigation The example shown above illustrates patient binder navigation note the toggle button is hidden beneath the View drop down list In record list navigation the binders are replaced by columns showing record status site patient visit plate and workflow level for all records in the current patient binder without needing to open each visit It can also be used when working on a task set in which case only task records are shown Visits and the pages within each visit are shown in visitmap order specified during study setup regard less of which navigation method is used 4 2 Metadata Queries Reasons and Missing Values In addition to having a value each field in the data window can have other information referred to as metadata If the current field in the data window has metadata it is displayed in the bottom left corner of the iDataFax window below the patient binders The 3 sub windows correspond to 3 types of metadata which are Query queries are requests for corrections or additional inf
193. t shown 1009 a a View Hospital Use the Show All Records for This Patient C Brantford Memorial Hospital button to open the patient binder and review l Hamilton General Hospital other records for the current patient Clicking this button again will return to Task Records only Show All Records for This Patient 43 iDataFax User Guide More than one user can work on the same task at the same time Each user gets a list of pointers to the records currently available for the task but a patient binder is locked only when it is opened and only one user can have the binder locked at a time Other users will be able to open the binder in view only mode until the lock is released Thus the next user to open a binder will get the current version of the data records including any changes made by the previous user Saving a task record changes the task icon from T to t but only for the user who saved the record Thus if more than one user is working on the same task at the same time it is possible that the task will have been completed by one user before another user opens the patient binder and that the second user will thus wonder why the record has been included in the task set A clue that this may have occurred is provided by the Last Save date time stamp at the bottom of the screen which may indicate that the record has been modified since the user began working on the task When you are finished performing a ta
194. t so they can check something or make a change With no deselection d option specified records will be retrieved even if subsequently saved today by someone else This task runs all edit checks E ALL on plate 1 P 1 data records that are currently at level 1 v 1 No edit check actions are applied Instead records will be retrieved if one or more edit checks would have added a new query modified an existing query displayed a message or changed a data field In this example the edit check E Checklnit is programmed to check patient initials and displays a warning message if they differ from some refer ence value In this task it will be run on all pages used in the study P 1 102 and thus will retrieve all records on which this message would be displayed The edit check programming language gives the programmer access to all data fields for all plates visits and patients and includes functions that can be used to test for the existence and status of queries and reasons Thus it is ideally suited for the definition of tasks that involve complicated record retrieval criteria All the programmer needs to do is raise a message using function dfwarning or create a query using function dfaddqc on records that are to be selected and use function dfbatch if the edit check is to be executed only when the task is being performed The following example shows how an edit check could be used to find unusually large changes
195. t task Attach each page to the data record identified below 44 DemoStudyLetters pdf Patent Plate Page Visit Assessment M 1001 2 Patient Entry Form 1 Baseline vw 1004 3 Medical History 1 Baseline HAMILTON MEDICAL CLINIC 9 Adverse Event 101 Adverse Event 01 25 Main St W Suite 500 Hamilton ON L8P 1H1 Canada o a es sy OO 90 922 9288 Fax 905 520 7204 Dr John Snow Date June 1 2009 To Demo study coordinator Re Adverse event report 01 for patient 01002 This patient slipped on the ice while shovelling snow and came down h Initially it appeared to be a simple case of muscle bruising but the paii and he has been off work now for 6 weeks Patient was sent for X Rays on Feb 18 2009 which showed no fractu Additional tests on May 14 2009 revealed spinal nerve damage and a which a surgical consult has been ordered This patient has been scheduled for surgery on June 8 with Dr Stricke General Hospital s 3 4 pages selected elect Al Deselect All POF Black amp White O Grayscale EERE O C impon Cancel This feature has 3 modes of operation chosen from the Select task list at the top of the import dialog e Attach all pages to the current data record To use this option the destination data record must be opened before Import Patient Documents is selected When the import dialog appears the keys identifying the current data record will be displayed in the spreadsheet and cannot
196. tate showing all data fields and data records but any task records will remain flagged with the T or t icon Clearing the current task set is a separate operation which can be performed using Select All Records 8 8 Exporting Data Records If you have permission to save data the records currently displayed in List View can be written to a file on your local disk by selecting File Save Data File The print dialog is illustrated below File Save Data File iDataFax Save Data File Page 001 Blood Pressure Screening To export the data records displayed in Field delimiter O default comma the List View window specify Lost code default O none specify e afield delimiter Column names none generic name O unique name e an output value for data fields in lost Data file name U k s p platel dat data records Users jack j el da pene Fen e column field names for first output row Warning Data will be saved with reduced fields e output data file on local PC a9 Cancel Any data fields which have been hidden using Select Field Selection will not be exported A warning message Warning Data will be saved with reduced fields will appear at the bottom of the dialog when this is the case 97 iDataFax User Guide 8 9 Exporting a Data Retrieval File A Data Retrieval File DRF containing the key fields of the records currently displayed in List View can be written to a file on your local disk by se
197. termined by the study coordinating center 30 3 16 Why did my iDataFax session Auto Logout lt Note If this occurs any unsaved changes to the last page you were working on will be lost and the patient lock will be released so that other authorized users can access the patient binder You can change the Auto Logout timer within limits specified by the study coordinating center by select ing File gt Preferences How to prevent an Auto Logout Auto Logout Dialog While the iDataFax application has the focus on your computer screen the timer is reset by You have been automatically logged out of your any keyboard action including just tabbing current session through fields e any mouse action including just moving the mouse If you switch to a different application iDataFax will Login again Em loose the focus and the timer will begin to count O down Of course logging out yourself after saving your work is the best way to avoid an Auto Logout If your last iDataFax session timed out you will see the dialog shown below the next time you login to the same study and you will be given the opportunity to return to the same Data Query or Reason view that was on screen when the Auto Logout occurred Returning After an Auto Logout aAA iDataFax Auto Logout Ti ANE EE If on Auto Logout there were unsaved changes Wed Jul 26 13 51 58 2006 to a page the page will be identified by patient Site 1 ID 1003 A
198. ther tasks by moving records from one work flow level to another when a task has been completed The default mode set when iDataFax starts is Modify and the default sign off level is set to your lowest write level defined in your study roles Mode sign off validation level and whether edit checks are on or off are also set whenever you perform a task or build an adhoc task set but they can also be changed at any time from the Select menu as shown below Select Change Mode amp Level YF DataFax Change Mode amp Level 2 This dialog can be used to change your mode Mode Modify ES sign off work flow level and to enable or Sign Off Level 1 FA M Enable edit checks disable edit checks but it is only available to users who have Data with Select permission oe Cancel The current mode and sign off level are shown to the left of the Save buttons at the bottom of the screen For example Save m 1 gt 2 indicates that we are in modify mode with a sign off level of 2 and that the data record is currently at level 1 Modes are identified by the letter m for Modify e for Edit and v for Validate and d for DDE When in view mode only the current work flow level is shown e g Save 3 and the message view mode is displayed to the right of the save buttons 50 4 9 2 Select By Data Fields 4 9 2 Select By Data Fields Adhoc task sets can be created using the same record selection dialogs already described in the se
199. there are unsaved changes and you try to move off the current page Last Save The record creation and modification timestamps written at the end of each data record are entered by the DataFax server in server time Thus regardless of where the data is coming from the timestamps in the study database will all be synchronized with the location of the server As an aid to end users the Last Save date and time shown at the bottom of the screen in Data View is displayed in the user s local time which is determined from the difference at login between server time and the system clock on the computer where iDataFax is running This may not actually be the user s local time if the user s system clock is not up to date or if the user is running iDataFax from an application server located in another time zone This is the only place where an attempt is made to use local time List View audit trail reports SAS exports etc all use server time The Message Window The message window located below the Save buttons displays the date and time of the last Save for the current page and may also display field level help e g legal values for the current field that has been specified by the study coordinating center Images iDataFax can store images as well as data This might include a faxed copy of the paper CRF or a scanned copy of some medical record or test result If images have been attached to the current page the image icon will ap
200. ting in more complete and accurate data entry and fewer queries from the study coordinating center To help realize these benefits and facilitate the transition from paper forms to EDC iDataFax has been designed with intuitive navigation using a patient binder analogy data entry screens that match the equivalent paper forms help in the form of status icons color coding messages and edit checks a Query window used to read and respond to queries from the study coordinating center a Reason window used to explain unusual data values and thus avoid queries and a Missing Value window used to mark fields with standard missing value codes 1 2 What type of computer do need Versions of iDataFax exist for Windows XP and 2000 Mac OS X Solaris and Linux If you plan to use iDataFax on more than one computer you will need to install the appropriate version on each computer 1 3 What type of web browser do I need iDataFax is a standalone application It does not reply on a specific web browser It may be downloaded and run on your local PC or deployed through an application server hosted by the study sponsor iDataFax communicates with the DataFax server using HTTPS on TCP port 443 which is also used by other secure web services such as online banking This port must be open on any firewalls between the two systems 1 4 Is data transmission over the internet secure iDataFax encrypts all internet transmissions using the same te
201. to a user within a task definition For example one task can be defined and used by all of the clinical sites because each site will only receive the data records they are allowed to see The following examples illustrate how data query reason and program criteria are used to define the records to be selected for different tasks 45 iDataFax User Guide Example 1 Search Data records i iDataFax Define Tasks E Task Drug Review 7 This example illustrates a review task for drugs Mode Validate B recorded on CRF page 4 Sign off Level 3 r M Enable edit checks which have reached work flow level 2 with status 5 Search Data Queries Reasons By program Final The expression a builder has been used to ae w Final _ Incomplete _ Pending _ Lost select records where the Site ss check if none data field Patient ID MEDNONE is empty Asasen code 0 because we only need to review pages on Page 4 amp which drugs have been Creatio ab E To be selected records Modification must meet all of the speci Pattern fied criteria The task is Expression S MEDNONE 0 By Performed in Validate mode with edit checks turned on On saving each record it will be raised from level 2 to level 3 Save Clear f Cancel 46 Example 2 Search Queries a Task New Queries Mode Validate S Sign off Level 2 F W Enable edit checks J Search Data Queries O Reasons 8y program Site Patient ID
202. to see and the counts shown for records available in the Unidenti fied Fax Router and the New Fax Queue will only be displayed if the user has permission to use Fax View and the Unidentified Fax Router 10 6 New Fax Queue The top of the screen Status View displays the number of study CRF pages that have arrived by fax and are waiting to be reviewed and entered into the study database These records are not counted in the Data table This count is only visible to users who have permission to use Fax View to review and enter these pages Double clicking on the count will open Fax View for such users 10 7 Unidentified Fax Router At the top of the screen Status View also displays the number of CRF pages that have arrived by fax but could not be routed to any of the current DataFax databases because the study number could not be iden tified These pages need to be reviewed and routed to the appropriate study if they are in fact study CRFs This count is only visible to users who have permission to use the Unidentified Fax Router to review and dispatch these pages Double clicking on the count will open the Router for such users 10 8 Returned QC Reports plate 501 Status View does not include any QC report pages that have been faxed back from the clinical sites and stored in the study database as plate 501 nor does it include any queries or reasons that may have been added to these records Returned QC reports and any associated metadata can b
203. trated below Page Change Bar Code AAA iDataFax Change Bar Code wv This page belongs to a different study Study Change from 1 to 2 When the Plate and or Visit number are changed the correction will appear immedi ately in the new record list on the left side of the screen but if the study number is changed the page is sent to the router and will be removed from the new record list of the current study OK Cancel 7 5 Switching to Data View While entering new records you can open the current patient binder to review and or modify other records using the Switch to Data View button at the bottom of the record list Before switching to Data View you will be asked if you want to save or discard any changes you have made to the current Fax View record The patient binder will then open to the current Fax View record in Data View This record will be tagged with the letter T in the record list to identify it as the current Fax View task record This record can not be modified while in Data View and will display View only record in use by Fax view in the message window at the bottom of the screen The switch button now labeled Switch to Fax View can be used to return to 84 7 6 Record Locking in Fax View the current Fax View record and continue with data entry when you are finished reviewing other records in Data View 7 6 Record Locking in Fax View Each set of CRF pages retrieved using the Automatic or Ma
204. tten in the margins of a paper case report form 6 1 The Reasons Table As illustrated above each reason is identified by the patient ID number assessment and page on which it occurs Under the heading Field Reason the data field is identified followed by the reason that was entered to explain the current value The last column shows the current status of each reason when the status was set and by whom When a reason is selected a bounding box is displayed around it as illustrated above for the 3rd reason in the table 6 2 Reason Status Reason status has one of 3 possible values e Pending the reason has not yet been reviewed by the study coordinating center e Approved the reason has been reviewed and accepted by the study coordinating center e Rejected the reason has been reviewed but has not been accepted by the study coordinating center For example some data fields may be essential to a study and only accepted as missing in very rare circumstances Typically when a reason is rejected the study coordinating center will add a query to explain why the reason is inadequate 6 3 Reasons View Menus This section describes the options available under the menu labels File View Show Reason and Help which appear at the top of the screen The File View and Help menus are the same across all views and have already been described for the Data view Show and Reason are the only menus containing options specific to the Reaso
205. value it can be typed into an empty cell or you can over type to change a completed cell Plate and visit labels will be displayed after the numeric value is entered in these cells If you don t know the numeric value for plate or visit a selection dialog showing the legal values and corresponding labels can be launched using right click Control S or by hitting Enter when the cell is empty Within the selection dialogs use the Up and Down arrow keys to find the desired value and then hit Enter to select it and close the dialog Plate must be entered before Visit and then only visit numbers that are legal for the specified plate will be displayed in the visit selection dialog To enter the same value in a range of cells in any column first select the cells click the first cell then shift click the last cell and then enter the value by typing or using the selection dialog To copy and paste the values from one range of cells to another first select the cells as described above then use Control C or right click Copy to copy the values then click the first cell in the desti nation range and finally use Control V or right click Paste to paste the values While working within a selected range of cells the Delete key removes the current value from all of the selected cells When all keys have been completed with valid values the space bar can be used to toggle the import selection check box on and off Page Context Pages imported in iDataFa
206. w Chapter 4 The Data View iDataFax File Edit Show Patient Assessment Page Field Help eoe iDatafax jack Demo Study 1002 3 of 18 Queries Je 1 G reasons D E Site 1 General Hospital esis Jape At 1001 53 a g v Booz Patient Patient MO Screening Visits Number 01002 initials BBB i7 1 Blood Pressure Screening FML vy ll Baseline MEDICAL HISTORY 2 Patient Entry Form 4 Current Medications Currently on Resolved gt R 21 1 Month Follow up Duration Treatment and or Controlled gt 22 2 Month Follow up Years amp Months No Yes No Yes r 623 3 Month Follow up Hypertension 06 gt J gt O r O Atria Fibrilation Sr gt p gt O Other Cardiac EG Arrhythma H 1003 1004 1005 Valvular Hea Myocardial Infa Kxiney Disease Query Problem Other Details Does the patient have any limitations or problems related to this value defect Reply jack May 11 2006 5 42 18 PM No Status Pending review Created dwt May 9 2006 11 19 24 AM Resolved Diabetes Stroke Transient lse c Attacks 0 Penphera Vascular Disease Reason for Data Value Reason Patient has a congenital mitral Other specify valve defect surgically corrected at age 6 r Status Approved Kneee surgery Created jack May 8 2006 1 04 23 AM Reviewed dwt May 9 2006 11 18 46 AM Save Incomplete Missing Value Last Save May 16 2006 4 55 53 PM Legal values are 0 80 The Data View is the
207. w job file will then appear in the text window and can be edited as described in the DataFax Program mers Guide to create the desired DFsas jbo file 99 iDataFax User Guide DFsas Add DataFax DF b Creat aratat Desas fon creation SASJOB new DFsas job file Required name SASJOB testS a RUNDIR location on the RUNDIR C studies demo253 sasjobs local PC where SAS job and PLATES 1 4 data files will be stored FIELDS include all O user defined only PLATES and FIELDS a Optional DFsas job file can include some or all data fields on Date Formats original L calendar _ string _ julian some or all study plates String Size Masis O truncate split max length Date Formats optional see below String Size long text can be truncated or split into multi ple fields If no plates are specified or ALL is specified all user defined plates in the range 1 500 plus DataFax plates 510 reasons and 511 queries will be included in the DFsas job If no date format options are specified dates are exported using the format and imputation specifications in the study setup Alternatively one or more of the following specifications can be selected e original turns off imputation outputs the value exactly as stored in the study database and creates a date informat for SAS e calendar performs imputation as specified in the study setup converts 2 digit years to 4 digit years and creates a date informat for SAS stri
208. we recommend using DFedits_test and reloading the published test file to avoid disrupting the production edit checks seen by other uers e Save Data Retrieval File create a DRF file listing the keys of all records in the current task set This allows you to reload this same set some time later Using Select By Data Retrieval File e Save As PDF create a PDF file containing data and or images from the current patient binder or task set Use this option if you want to print blank CRFs print fax and data records side by side or include data records with the same field color coding used in iDataFax e Save As Bookmarked PDF create a PDF file containing data and or images from the current patient binder or task set This option includes many of the same options as the command line program DFpdf and includes a navigation sidebar indexed by patient ID visit and plate Use this option to produce a PDF containing any combination of CRF images and data records to bind speci fied data fields e g for endpoint ajudication committees and to password protect the PDF file Enter field blinding specifications as follows plate s field s plate s field s and use for all plates and or all fields For example 8 blind field 8 on all plates 1 5 8 9 22 25 33 blind field 8 on plates 1 5 and fields 22 25 and 33 on plate 9 e Save Task Set create a PDF file containing the data record keys set creation method set instruc tions user name an
209. what they do and how to use the options This documentation can be reviewed by selecting a report fro the report list and then clicking the Explain button e Run To run a report select it from the report list and then click the Run button The output will be displayed and added to the history list 2 8 List View The List View can be used to review all data records for a specified CRF plate in a table where each column is a data field and each row is a data record 16 2 8 List View iDataFax File Edit View Select Show Page Field Help Pe Dace bn Se ME R aa R R As asa AOA Fax IEF iDataFax dwt t420sparc datafax com DEMO 253 List 2007 1 2 5 of 28 Data 2D ID A PINT EDATE EUC EUGEX BDATE WTKG WILE HTCM HTIN PULSE SMOKE EXERCIS Queries 0 1 BP f 1006 BOS 02 01 11 2 07 10 54 167 5 072 0 046 1 3 conbad JER o 002 Patient Entry Form R rt xe 004 003 Medical History aiaa 004 Baseline Meds page 1 Satu HS 2005 NNN 22 12 10 2 05 06 32 155 5 170 ae 2 005 Monthly Follow up Forn ihdkskk Lios pwr Hooson 06 07 40 065 5 MME 180 070 4 4 006 Patient Evaluation Report SA E x n 2007 11 11 10 2 1 082 0 068 2 007 Study Termination satan 02007 11 10 208 382 0 6 l 008 Medication Change Log 6 02008 POP 08 06 10 2 33 3 B osse 067 1 1 009 Adverse Event 02009 QWE 11 09 10 2 1 166 BBM oso 2 3 010 Death Report x 1 j a gt 2 011 Weekly Patient Diary 8 02011 JOK 19 08 10 2
210. with specified visit and or plate numbers If you have a stack of CRF pages that need to be entered but not faxed into DataFax you can use Fax View in Raw Data Entry mode to enter these pages or use Data View to perform the same task The only difference is that data entry in Data View is performed within one patient binder at a time while Fax View allows you to work outside of the patient binders New records are typically saved to the study database at work flow level 1 but it is possible to save new records directly to other levels Fax View is typically used only by data entry staff at the study coordinating center this option is not normally made available to clinical sites 7 1 The Record Selection Dialog Fax View supports 4 options under the Select menu for building a set of records to be entered These include Automatic Retrieval and Manual Retrieval for entering data from faxed CRF pages Raw Data Entry for entering data from hardcopy CRF pages held outside of DataFax and By Task which applies automatic record selection rules which have been predefined for a particular user or study role using the Define Tasks menu option Manual Retrieval allows the user to cherry pick records from the list of faxed pages awaiting data entry or search for records with specified plate and or visit numbers as illustrated in the following example 79 iDataFax User Guide Select Manual Retrieval New queu
211. x S1 S 19 S1DB8P3 Screen 1 Read 3 diastolic number til n a M DOM MEL OK Reset amp Cane GP Numeric Codes and Code Labels Expressions must be created using code labels as in the above example for sex only when labels are being displayed in List View If the numeric codes are being displayed expressions must test for the codes not the labels 91 iDataFax User Guide Functions concat s1 s2 Use concat to test the concatenation of 2 strings e g to find records where the concatination of 2 fields named Mtype and Mnum combined to give the value A1234 concat Mtype Mnum A1234 day n Use day to test for a day of the month in a date e g to find records where Screen 1 Date occurred on or after the 15th of any month day S1DATE gt 15 decimal n Use decimal to test the decimal component of a number e g to find records where weight is not a whole number decimal WEIGHT gt 0 field s n Use field to test a specified word in a string e g to find records where the 2nd word in a drug name is ACID field DRUGNAME 2 ACID 92 index s1 s2 int n julian yyyy mm dd length s month n 8 6 Searching Data Records Use index to find the character position in string s1 where string s2 first occurs e g in the following statement local variable X will be set to 3 number X index A56GH9 6GH Use int to test the
212. x are registered in the DataFax fax log so the Context option can be used to identify when and how they arrived However since pages are selected and imported individually the entire PDF is not copied to the DataFax fax archive the way it is when a fax arrives or a PDF is transmitted by the method described in the previous section Page Context iDataFax Context Fax Name 1045 0011001 ses 1 A tika import POF Jack Images imported from iDataFax are identified in a NE AN A aie the Context dialog with the label iDataFax Import PENT SI TUS ROVE TAU SOLD PDF username as illustrated here 65 iDataFax User Guide 4 16 Data View Menus This section describes the options available under the menus displayed at the top of the screen The specific menus displayed and the availability of options under each menu will vary depending on user permissions and whether an action is allowed at any given time 4 16 1 File Menu The File menu is similar for all views data queries and reasons and contains the following items e Reload users with iDataFax Developer permission can use this option to reload lookup tables reload edit checks and trace edit check execution These functions make it possible to modify edit check code republish it and then reload the edit checks to test the modifications and trace edit check execution as the user enters and exits records and fields When working in a production study
213. you traverse the data records all relevant queries and reason on the current record will appear in the dialog As you select each query and reason in the dialog the relevant data field will be highlighted in the data window making it easy 58 4 13 Review Approve Queries and Reasons to see the relevant item The Review Approve dialogs are generally used to review and approve new reasons and query replies but as needed you can also modify or even delete queries and reasons if your permissions allow it There is one limitation Changes cannot be made to queries and reasons on Pending level 0 data records as this status indicates the user was interrupted during the entry of a new record and intends to complete it before it is reviewed by study managers The 2 buttons below Query Status and Reason Status can be used to save your changes to the current query or reason before moving on to the next one or you can delay saving changes until all queries and reasons on the current data record have been reviewed in which case an asterisk will appear beside each query and reason with unsaved changes The Save button at the bottom of the dialog saves the reason and query on the current field simultaneously The Done button dismisses the Review Approve dialog without saving any changes If you change the status of a query in these dialogs to New or Revised or you Reject a pending reason the data field will turn blue and when the que
214. your electronic signature and can be traced in DataFax audit trail reports A page can be saved with status Final if there are no illegal values or unan swered queries from the study coordinating center iDataFax marks Final pages with a green check mark See also Incomplete and Pending A page can be saved with status Incomplete if it has any fields which are incom plete or illegal or outstanding queries iDataFax marks Incomplete pages with a red X see also Final and Pending Page and plate are 2 terms used interchangably to refer to a logical grouping of data items aka data fields presented with a layout determined by the study sponsor to fit on a single sheet of paper Each page may stand alone or pages may be grouped into multi page forms A collection of pages or forms constitute an assessment and a collection of assessments constitute the patient binder which holds all study data for an individual patient In a paper based approach to data collection these pages are printed completed and faxed to the DataFax system When using an EDC approach the same pages are completed using iDataFax An individual participating in a research project for whom data will be collected is a patient Within iDataFax patients are identified by patient ID number a unique numeric identifier according to conventions established by the study coordinat ing center A patient binder contains all of the required and optional data collection for

iDataFax User Guide - CLARITY Randomization Website

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