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1. Updating the validation report Sending form and rule messages Freezing or unfreezing follow up forms Setting the patient status Setting the AE status opening or closing AE Answering queries Withdrawing reviews f a revalidation has been carried out any reviews that have been created will be reset As a revalidation changes the form value the form status or the error messages a renewed form check is advisable SDV If in a score item the item value has been changed by the revalidation and if SDV had already been conducted the SDV status for this item and if applicable for the form will be reset Query answering If there was an open query for this changed score item and if automatic query answering has been configured for the project the revalidation will also trigger this function and the query will be answered providing you also has query answering rights for the form If an e signature is required for the entire project for an individual form or for the revalidation func tion after validation the form will be displayed again for entering the e signature together with any error messages The e signature is also required for the revalidation if a query answer is triggered as a result and an e signature is required to process the query If an e signature is necessary to freeze a form and if the revalidated form contains a form freeze rule the e signature will be likewise requested regard less whethe
2. Review A activates the first data review and locks the medical data form against further edit Ing REVOKE REVIEW A will revoke the data review and re enable data entry Any data that has been modified will not be saved by the review Review B activates the second data review and locks the medical data form against further editing An open query can revoke a Review B and or prohibit it Any data that has been mod ified will not be saved by the review FORM FREEZE irrevocably locks the form After this no medical data can be edited and no other actions can be performed Locking a form may only be revoked in exceptional cases by the secuTrial administrator SAVE CLOSE ENTRY Saves the entered data and at the same time ends the data entry After wards the form is symbolised with a green icon and monitoring the data may begin Sub sequent data changes are now only possible with a query see chapter 6 2 Save MODIFICATION saves the data modification for a question which has been released for editing through a query For this kind of change you must give a reason You must also remember to actually answer the query see see Entering and Viewing Comments and Quer ies The DEC Data Entry Complete can be revoked as long as no query has been created and no monitor work flow has been conducted see chapter 6 2 Not all data entry functions are necessarily available in every form The type of data entry varies depending on
3. Preferred report You can select a preferred report for your user account which will then be imme diately displayed after logging in instead of the usual Welcome page unless you activate the box only as menu item You can only select reports that are permitted for your role s AutoTab enabled For some items e g number items with post decimal digits as well as date and time items it can be configured that the cursor automatically moves to the next input element if the last possible value e g complete month has been entered Without specification per participant the setting in the project or customer design is used This AutoTab feature is explained in a short online help Change password Here it is possible for you to change your password The new password has to be confirmed by double input It has to fulfill the general requirements regarding length and composi tion configured per customer in the CustomerAdminTool Preferred language You can also select your preferred language All of the buttons and general headings in the programme to which you have access will then be displayed in that language At the present time German and English are available If you do not make a selection the default setting for the project or current customer will be used Sec ulr q en Pi 3 14 54 CET MyAccount Messages Import Reports New patient Select gt My Account Last name Waler First name Title Gender C Female
4. 32 32 1000 900 Meaning external discrepancy ID external test ID Time of test run MEZ MESZ Name of affected table Name of affected column Item ID of affected dataset mnpdid ID of affected patient Test error message Instruction to centre 2 2 02 03 2007 mnpmtlpersonal age 229 39 Age unclear check entry age 260 43 Age unclear check entry 3 2 02 03 2007 mnpmtlpersonal weight 271 35 Weight incorrect check entry 2 2 02 03 2007 mnpmtlpersonal 7 2 Form Data List format This format is only valid for individual imports All key value pairs must be listed individually in one row Example individual import entries Allergies cats Examination 120520081156 CSV Format File type CSV Unzipped File structure Line by line entry of datasets First line contains names of the values listed below Entries are separated from each other by delimiters defined in the FormBuilder The delimiter may not be contained within an entry The dataset identifiers must be unique in a project multiple instances of the patient variable or the form field are not permitted The variable defined for the form field cannot be additionally imported as a value in the example below the variable Name Pat I1D A form field identifier may only be used in already saved forms Example mass import entries Data record identifier by pa
5. Male Phone PO Mobile phone PO Fax PO Email Location Street Zipcode City DOO OSS O Country lt Please choose gt y Preferred report lt Please choose F only as menu item AutoTab enabled 2 lt default gt Change password New password Confirm new password Preferred language E default gt Cancel save and back Save Fig 4 The My account page 3 5 Downloading optional On the Welcome page there is an option for you to download documents Click on the corresponding document name under the welcome text to download the document or open it directly with the relevant application 3 6 Creating and editing new patients To enter medical data in secuTrial DataCapture you can either edit an already existing dataset or add a new dataset for a patient To add a new patient click on the New PATIENT button at the top right of the main menu To edit an existing dataset enter the patient s pseudonym in the input field at the top right of the page and then click on SELECT or press the enter key on your keyboard 3 7 Mass import of form data On the Welcome page you will find an optional IMPORT button for performing imports of medical measurement data in multiple patients at the same time or importing discrepancies see Fig 5 The IMPORT button is only available if you have the role right for mass import and for forms that have been configured accordingly or if you have the role right for
6. Pr Dr Jonas 233009 secu Fla DYMD 14 10 2010 13 14 31 CEST Patient Login Edit isitplan Patientfile New patient Select gt Edit Visit plan Hide history Entry date 01 01 2000 CET 1 visit 01 01 2000 CET 11 01 2000 13 01 2000 Pr Dr Jonas 14 10 2010 13 18 CEST rest 13 01 2000 15 01 2000 Pr Dr Jonas 14 10 2010 13 19 CEST new 2 visit 15 01 2000 CET 10 04 2000 12 04 2000 Pr Dr Jonas 14 10 2010 13 18 CEST rest 12 04 2000 14 04 2000 Pr Dr Jonas 14 10 2010 13 19 CEST new 3 visit 14 04 2000 CEST As long as there has been no data entered yet into a visit you can change the visit date You can only change one date at a time All subsequent visits will be shifted accordingly For unscheduled visits you can change the visit type too Entry date 01 01 2000 CET 1 visit 01 01 2000 CET 2 visit 15 01 2000 CET Edit 3 visit 14 04 2000 CEST Edit Cancel Reset Preview Fig 35 History of all changes to visits 5 When changing the visit plan the patient s file will be automatically locked Therefore it is not pos sible for more than one participant to edit the file simultaneously Even if just one form of the patient has been opened that patient s entire file will be locked You will also only be able to make changes if you are permitted to edit at least one form If this is not the case a message will be displayed accordingly Deleting visits The last planned v
7. Welcome to secuTrial This is the opening page for data entry lt serves as a central point for various functions messaging help and data overviews reports If there are any new messages these are displayed in a new window straight after logging in At the top left you can see your name and the current date Always check these details first to make sure you havent inadvertently logged in to the wrong account The LOGOUT button here and in other windows logs you out of the system immediately Changes are not saved Please log out whenever you leave your computer so that nobody can use the system under your name After 20 minutes without making contact with the server you will be logged out automatically timeout Ifthis happens you will also lose any unsaved changes From your user ID the system recognises which centre s you have access to The NEW PATIENT button lets you enter a new patient and create the according patient record In order to access an already existing patient record enter the patient pseudonym Pat ID Add ID or Lab ID into the free text field Then click on SELECT to view the according record for the patient By clicking on the HELP Button you will always receive additional information and explanations for the features available at the current page From anywhere in the program you can go back here by clicking on the WELCOME button secuTrial 45 Berlin 2010 Fig 3 Welcome page overview a This page is the ce
8. Example study 15 08 2013 17 37 53 CEST gt Select a centre Berlin Create new patient Include existing patient into centre Create Visitenplan Label Please enter date of entry first visit as the basis for the visit plan damn Entry date E fog 2013 CETICEST Cancel Continue Fig 20 Function options for creating a new patient to be included in a centre e When changing centres in the AdminTool all the visits from the original centre will also be trans ferred to the new centre 4 2 Entering and editing datasets form overview To edit an existing dataset enter the pseudonym in the input field at the top right of the main menu and click on SELECT or press the enter key The Form overview overview page for editing forms will now open 14 10 2010 13 15 CEST Greifswald DYMD i i Pr Dr Jonas aaa009 secu Fla DVMD 14 10 2010 13 14 31 CEST Patient Login EditVisitplan Patientfile Mew patient Select Visit plan AE Begleitmedikation DWMD y 1 visit 2 visit 3 visit Next visit Planned visits 01 01 00 11 01 00 10 04 00 Data entry 21 05 10 Demographic E Smoking Habits Vital signs Contraception and Pregnancy InfExclusion Citeria Labor Review Review Review Review patient visit visit visit Freeze Freeze Freeze Fig 21 The Form overview The form overview is the main starting point for entering or editing patient data The symbols provide a quick overview of the status see
9. Line by line entry of datasets testdate gt 3 05 2007 lt testdate gt testtext gt Entry improbable lt testtext gt testdate gt 4 05 2007 lt testdate gt testtext gt Improbable entry lt testtext gt testtablename gt mnpmtlcheckboxmatrixl lt testtablename gt testcolumnname gt sondrogen lt testcolumnname gt testmnpdocid gt 229 lt testmnpdocid gt testinstruction gt Check entry lt testinstruction gt testtablename gt mnpmtlcheckboxmatrixl lt testtablename gt testcolumnname gt smokes lt testcolumnname gt testmnpdocid gt 229 lt testmnpdocid gt testinstruction gt Please check lt testinstruction gt First line contains the names of the values listed below Entries are enclosed by inverted commas Entries are separated from each other by semicolons No semicolons are permitted within an entry White space between the enclosing inverted commas and the separating semicolons will be ignored Empty entries are entered by consecutive inverted commas Only entries for test text and test instructions may be empty The order of the entries must match the following description Entries Name testdcnr testnr testdate testtablename testcolumnname testmnpdocid testpid testtext testinstruction Example Doublet search yes yes yes yes yes yes Type Integer Integer Date String String Integer Integer String String Format Width dd mm yyyy
10. 20 03 2013 12 50 11 CET V DDE 2 Document No 152 Phi 28 03 2013 13 13 51 CET ODE comparison finished Signature valid 20 03 2013 12 55 55 En Phi 28 03 2013 125459 CET DDE entry completed Mot signed 20 03 2013 12 50 11 CET Changes in document Fig 27 Mo changes were made in this farm Document history in the Audit Trail of a DDE form after completing a comparison Further monitoring can only begin after completing the double data entry by comparing the DDE datasets Only then can queries or comments be made and a review or SDV be implemented Status display DDE An abbreviation is displayed before the form name to indicate the status in the DDE work flow for individual forms and roles Form status DDE entry DDE comparison Role right unsaved DDE entered complete finished without DDE 1 2 1 2 DDE 1 1 1 v1 DDE 2 2 2 V2 DDE 1 and 2 1 amp 2 1 amp 2 V1 amp V2 Double Data Entry Labor data 1 ml Labor data 2 Results Fig 28 DDE forms in the form overview with the DDE set indicated as a prefix 1 2 see table above In this example the participant does not have the DDE right for the form labor data 1 only the DDE 1 right for labor data 2 and both DDE rights to the Results form Example Data entry and executing at configurable randomization Randomization To execute the randomization process all of the entered str
11. DICOMDIR Series Image Selector Modali Series Desc dicom F Filename localizer i 1 3 12 2 1107 5 2 6 238 2 13 122 1107 5 2 6 238 es 134224075 26238 formations 4 1 3 12 2 1107 5 2 6 233 Modality MR 1 3 12 2 1107 5 2 6 238 Station Name MRC25320 1 3 12 2 1107 5 2 6 23g Instance Number 3 Slice Thickness 8 KVP n a Series Date 04 04 2006 Series Time 09 09 24 File Size 569 Fig 50 Upload DICOM image select the images from the DICOM DIR After you have selected one or more images a progress bar will appear indicating the approximate time required for the upload a Willkommen bei secuT nal 3 4 0 6 1 Image upload Kunde Mozilla Firefox Mic EGUE https asp staging interactive systems de cgi bin WebObjects 1502 setup DataCapture woa l LT Date 14 10 2010 16 06 CEST Patient Patil aaa009 B 4dd 0 lt not set Clinical Investigator Pr Dr Jonas Images Imageform Project DVMD 14 10 2010 15 51 51 CEST 14 10 2010 CEST Pr Dr Jonas Centre Greifswald DVMD Dicom Upload version 3 4 0 6 1 Uploading file 15 93 51420440 13563K 14794 195 6K Threads 9 29 Applets 1 Upload in progress Transferred 1 11 MB 10 53 MB Bandwidth 0 0 kB s Elapsed 00 00 00 Remaining 2 WARNING Closing this window will cancel your upload 16 11 19 uploading file 18 93 51420440 a D 14 8 85 E 0 Fig 51 Upload DICOM image progress bar during
12. If there are any deviations all of the deviating data is individually listed in red Correctly corresponding data is indicated with a green text and a check box can be selected next to the form All visible check boxes can be selected or deselected together using the links below the list Reload Print Close DOE comparison Systemtest 441 DDE 1 DDE 2 Ready 232049 lt not set gt DDE Form 1 Startvisite 05 03 13 The form has not been saved yet aehii0 lt not sete DDE Form 1 Startvisite 07 03 13 quks209 lt not set OOOO he data entry is not completed yet The data entry is completed grade lt not set Dbl data entry finished O U U O fhitbs lt not set gt ksb643 lt not sete DDE Form 1 Startvisite 78 03 13 Double data entry finished Cancel Save comparison Fig 25 DDE comparison pop up for a patient If a deviation is found when comparing the hash value of images this will be indicated by the words hash value after the image text After all or individual corresponding forms have been selected for comparison you can complete the comparison by clicking on the SAVE COMPARISON button An overview will then be displayed listing which forms can actually be saved in the next step The second list is necessary in order to lock the forms against editing so the comparison can be saved The comparison can also be viewed if one or more forms are currently being edited Forms that another participant currently has op
13. lt xml version 1 0 encoding UTF 8 gt lt DOCTYPE file SYSTEM discrepancies 01 dtd gt lt file project SRT gt lt discrepancy testdcno 100 gt lt testno gt 1 lt testno gt testdate gt 01 05 2007 lt testdate gt testtablename gt mnpmtlcheckboxmatrixl lt testtablename gt testcolumnname gt pregnant lt testcolumnname gt testmnpdocid gt 229 lt testmnpdocid gt testpid gt 39 lt testpid gt testtext gt Entry outside normal range lt testtext gt lt testinstruction gt Check entry lt testinstruction gt lt discrepancy gt lt discrepancy testdcno 101 gt lt testno gt 1 lt testno gt testdate gt 2 05 2007 lt testdate gt testtablename gt mnpmtlcheckboxmatrixl lt testtablename gt testcolumnname gt female lt testcolumnname gt testmnpdocid gt 229 lt testmnpdocid gt testpid gt 39 lt testpid gt NA AKAN A NA AA A lt testtext gt Entry improbable lt testtext gt lt testinstruction gt Check entry lt testinstruction gt lt discrepancy gt lt discrepancy testdcno 102 gt lt NA AAA A lt testno gt 1 lt testno gt L testpid gt 39 lt testpid gt lt discrepancy gt lt discrepancy testdcno 103 gt lt NA AAA A lt testno gt 1 lt testno gt q4 testpid gt 39 lt testpid gt lt discrepancy gt lt file gt CSV format File type CSV unzipped File structure
14. A ee te ea 69 PD DOM GIs ci OO dl 11 PR DTM ds dd ii das 71 ANE TO oie Bare cere a E Eeteensttte eatin It any rte Seren Here Meee ee eae ee eee eee 71 PP O Re Rea tre eee ae eh ee eee 72 De THOU elastase ic o O ot wo ance te ead nye E E asaes hee 73 KIS CIONA amen Seem meee ae RES ee T ere ena ed oe eet ee te ene Ae eA eee 73 CSW FOMI ea ices ayo sak cette A AR 73 This manual is designed to make using secuTrial DataCapture as easy possible DataCapture enables you to conveniently enter and manage patient data This step by step guide explains the individual functions for creating editing and managing your patient datasets Since 4 7 In the current version the following new functions have been introduced Multi mass imports MMI Data entry with missing values MV Freeze all forms of a patient 1 1 System requirements You can use secuTrial DataCapture with a number of operating systems for example Windows MacOS or Linux No special software needs to be installed on your computer in order to work with secuTrial Data Capture The software that is required for this tool is installed on a central server To access the soft ware all that is needed is a standard browser Microsoft Internet Explorer Google Chrome Mozilla Firefox Safari etc We recommend using Mozilla Firefox or Microsoft Internet Explorer from Version 6 0 JavaScript and SSL encryption must be enabled in your browser and MetaRefresh mu
15. Demographic la D Smoking Habits a Vital signs a Contraception and Pregnancy P nancy y InfExclusion Citeria Labor Review Review Review Review patient visit visit visit Freeze Freeze Freeze Patient vist vis O visit Fig 58 Form overview with configured SDV and the summarising visit and patient status There are now two options You can either change the SDV status of all the items simultaneously or only change the status of items whose current SDV status is marked as not done Select the option you require from the dropdown list then specify the desired SDV status Confirmation SDV for all Forms of 1 Start visit all not done states setto O deferred not possible A not necessary O verified AN data in the following form will be saved with the following signature 1 Start visit Se VE SMS esi irae Source data verified F Siqnature By entering your user lD and password you are confirming that you Source data verified User ID Password Cancel Sign save Fig 59 Selection for SDV visit with entry of the affected form s here Form 1 Confirmation SDV for ygo680 all not done states setto deferred not possible not necessary verified M data in the following forms will be saved with the folowing signature 1 Start visit 20 03 2013 CET Form 1 Source data verified 2 v
16. a Queries created due to a discrepancy will be indicated with the letter A a Discrepancies can continue to be viewed in a closed project but is not possible to import new dis crepancies For inactive projects neither of these functions are possible 3 9 Mass action If role rights have been set you will be given a new Mass AcTION menu option on the welcome page This can be used to start simplified monitoring actions see Fig 14 This right can be assigned to participant roles only m amp 29 01 2013 14 39 CET secl ria Dipl biol Susanne Schneider Validation report by Account Messages Mass Action Reports New patient Select gt Mass Action Project Example Study Centre all centres Centre Visit allyvisits Visit Form all forms O Form Perform action Review A al Not saved forms Cancel Analyse Fig 14 Page for starting the mass monitoring actions via the new menu option Mass Action Here you can make a selection from all projects centres forms and actions for which you have the corresponding action rights as well as the new right to perform a mass action The following actions can be carried out as a mass action Review A Revoke review A Review B Freeze forms Form revalidation For all actions except for revoking review A it is possible to select whether unsaved forms should also be edited After selecting the action click on the Anal
17. a single project version the version label will be appended to the report name If the participant has access to multiple versions of the same report only the newest version will be listed For the display of the single report the listed report version will be used for all centres even if differ ent project versions are used in the different centres With image status and icon reports the project version of the respective centre is used to calculate the displayed value Query reports will only list the queries which can actually be displayed based on the currently used project version Queries referring to hidden items are accordingly marked in the list Queries regarding items that are no longer displayed because of a version change will not be lis ted seculrial oon aller MyAccount Messages Reports New patient Select gt Reports Statistics Systemtest 441 Systemtest 441 Ausf llstatus 2 Studienverlauf 1 Fehlermeldungen 2 Fig 61 Report name and project version label are displayed Statistics are completely independent from the CPV function and are always generated with the pro ductive version Download Documents The list of productive download documents on the welcome page with sufficient role rights can be expanded with all documents of older versions if these documents still exist in the productive pro ject Therefore the documents from other versions are compared to the productive version If they differ th
18. current role of the participant or pa tient has been defined in such a way that creating visits depends on form rights the participant or patient must have editing rights to at least one form of the unplanned visit in order to be able to cre ate this unplanned visit If you only wish to view one visit for reasons of clarity you have the option of displaying the previous visit using the link PREVIOUS VISIT 4 4 Changing an existing visit 14 10 2010 13 15 CEST Greifswald DVMD Pr Dr Jonas aaa009 Secu ria DVMD 14 10 2010 13 14 31 CEST patent Gir Ea Viton Patni New patient Select Visit plan AE Begleitmedikation DVMD gt 1 visit 2 visit 3 visit Next visit Planned visits 01 01 00 11 01 00 10 04 00 Data entry 21 05 10 Demographic E Smoking Habits AkAtitbala Fig 33 Visit plan with a link for changing the visit type and date highlighted Changing a visit plan 5 Regardless whether forms have already been saved in the visits the entry date and the planned visit date for all visits can be edited if the right to edit and display the EDIT visiT PLAN button has been con figured for the current role The editing is recorded in the visit plan history and a reason must be entered When changing a visit date all following planned visits are shifted accordingly providing the date of a subsequent visit has not been changed directly In this case the change will be recalcu lated and implemented from the
19. entry by checking the existing rules and form actions The purpose of the revalidation is to provide a facility for checking the data even if there is no data editing option In an individual form the revalid ation cannot be conducted if you also has the option to edit the data either wholly or in part during modification after DEC In this case the validation will be carried out anyway when saving data Otherwise the following conditions for performing a revalidation are required Form revalidation right Individual form no possibility to edit the data No form freeze The patient is not frozen for editing or deceased During a revalidation the results of the rule evaluation are checked as follows Changes in score items Changes in form completion status and error warning status Changes in the validation report If there are changes in one of these three checked aspects the validation will be conducted with a corresponding adjustment of the values and logged as Data revalidated in the AuditTrail of the form All of the follow up actions defined for the form such as rule or form messages freeze or release follow up forms or set patient status will then be performed In summary the possible effects of a revalidation are as follows see details below Saving the form with score value changes and or changed completion status Resetting review A and B Resetting the SDV status only if necessary
20. importing discrepancies see section Discrepancies Transfer Module DTM al 03 06 2014 20 01 CEST secl Fla ant Dipl Biol Susanne Schneider hy Account Messages Import Reports New patient Select Import Please select the type of import Form data for single form Form data for multiple forms Discrepancies Fig 5 First set of options when performing imports with DTM and mass import right Mass import for a single form Only the CSV parser can be used as a parser line 1 variables values from line 2 onwards one line per patient To conduct a mass import perform the following steps ial 14 10 2010 15 43 CEST secu Fla Pr Dr Jonas My Account Messages Import Reports New patient Select gt Import of form data Import of Form data y Please choose the form into wich you want to import patient data You can only import data to wich you have sufficient access rights Project DYMD y Form lLokales Labor y Select an import format Labor y Visit plan fivist y select the file for upload o Durchsuchen ISO 8859 15 Upload Fig 6 Selection page for the form data mass import 1 Click on IMPORT in the main menu top right of the Welcome page and select Form data for single form 2 Now select the relevant project 3 If import formats have been configured for visit and case node forms you now need to select either visit plan or case node 4 Next select the form a
21. input field will be transferred into the form In catalogue aided fields you can also manually enter data without using the catalogue selection function However in these fields only values or text entries are permitted that are stored in the data base of the corresponding catalogue When saving the form the contents of the catalogue fields are carefully compared with the contents of the catalogue in the database For this reason it is generally not possible to save values or combinations of values which are not specified in the catalogue All levels of the catalogue have been filled out in the form One of the entered values does not exist in the catalogue gt An error message will appear when saving the form and the values must be corrected The individual values exist in the catalogue but the combination of values does not result in a clear entry gt An error message will appear when saving the form and the values must be corrected If several but not all levels of a catalogue can be filled out in the form All fields of an upper catalogue level have been fully and correctly filled all subordinate levels have been left empty This basically equates to selecting a category entry in an upper catalogue level in the catalogue window gt The form will be successfully saved Fields on an upper level or the same level have been left empty gt If a clear catalogue entry can be identified from the filled out fields t
22. it is possible to tell from the preceding letter whether a query was created following a manual or auto matic test A automatically or M manually To answer a query click on the respective QUERY button and enter your answer in the input field If a question contains several items you can choose an individual item to query or create an answer When have finished your entry click on Save to save your entry It is only ever possible to save one entry per item at a time To delete an unfinished entry click on CANCEL To permanently close a query open a previously answered query and after entering your text select the option RESOLVE QUERY The option REOPEN QUERY permits further comments until the query has been closed When closing a query the default entry text completed will be provided You may however edit this text before closing Important To withdraw a query this option must be activated for the project You can then withdraw previously asked answered or closed queries with the option WITHDRAW QUERY The query then has the new status withdrawn and is no longer taken into account when calculating the query status of the form If all of the queries in a form have been withdrawn then no queries will be displayed in the form icon The form status is then the same as for a form without queries A withdrawn query remains but it can no longer be edited It continues to be listed in the query list for the form and in the query r
23. must not be any open queries or any other type of not done SDV status The right to revoke the DEC status is linked with the right to set a DEC status If an e signature is required for setting the DEC status it will also be required for revoking it RepetitionGroups In a DEC project if the option Repetitions after DEC has been set for a repetition group in the FormBuilder after asking a query and on the condition that the DEC status has been set in the form the DEC status cannot be revoked the form and the patient have not been frozen the participant has the editing rights to make changes the More button will be displayed in DataCapture You can then create new repetitions of this repeti tion group In the form only the new repetitions can be edited When saving a reason must be entered and the data entry will be recorded as a data change Any existing review status will be reset by extending the repetition If the form has already been set to the SDV status verified extending the repetition will set the SDV status to in progress and an SDV reset message will be sent if a notification message has been defined for this case in the pro ject 6 8 Revalidation If the role right Revalidation has been configured for your role in the AdminTool you will see a REVALIDATION button WHEN EDITING FORMS A revalidation conducts the same data validation evaluation which is carried out with a normal data
24. of time session timeout The exact time until timeout will be shown in the browser title bar of the main browser window 2 2 Change password The first time you log in to secuTrial you will be asked to change your password You can also change your password at any time by clicking on the CHANGE PASSWORD button on the Login page For security reasons your password must comply with certain criteria The password must contain a minimum number of characters configurable six to 10 charac ters default 8 and include a non alphabetical character number dot slash etc It should not be identical to the old password You will be regularly prompted to change your password default every 6 months When choosing your password please be aware of any SOPs that may apply to you If you enter your password incorrectly three times your account will be locked Should this happen please contact your secuTrial administrator who will assign a new password to you The amount of allowed failed attempts may be configured differently You may ask your participant management for further details Please also observe the applicable regulations and requirements regarding clinical studies and data protection After you have logged in the Welcome page of secuTrial DataCapture will open sal Date 14 10 2010 15 41 CEST secu Fla Participant Pr Dr Jonas Help Logout elcome Messages Import Reports New patient Select gt
25. scores are automatically calculated when saving and then displayed in the print preview a The rules defined for calculating score fields are evaluated in a preliminary step before evaluating the data check rules This ensures that the rules for checking the calculated score values can always be correctly evaluated regardless of whether they are defined above or below the score item in the form 5 4 Catalogues Catalogue aided entry is a special method for making form entries If a catalogue has been specified for a question this will be marked by a CATALOGUE button to the left of the question Catalogue Diagnose ICD 10 ICD additional Fig 44 Catalogue entry fields Click on the CATALOGUE button to the left of the question to open the catalogue in a separate window Browse through the catalogue and select an entry The values of the selected catalogue entry will then be transferred into the respective input fields of the form Frint Close MedDRA_Test_20091216 100754 dC Sen Reset S0C Name S0C Code HLT Mame HLT Code M PT Mame PT Code MILLT Name MILLT Code Poo SOC Name soc HLGT Name HEGT HET HET PT PT LiT LiT Code Code Name Code Name Code Name Code Blood and lymphatic 10005323 system disorders p Anaemias nonhaemolytic 10002066 and marrow depression bo Cardiac disorders 10007541 gt Congenital familial 10010331 and genetic disorders Fig 45 Opened catalogue In the catalogue window you can
26. signature author date reason will generally be documented at the bottom of the form and shown both in the online preview and in the print preview Depending on the project configuration during certain phases of the study it may well be intentional and legitimate for there to be no electronic signature 6 12 Hide After a project is setted to productive mode items questions or forms can not be deleted anymore in the FormBuilder Instead they can be hidden by configuring this accordingly in the FormBuilder The hidden objects will not be accessible in DataCapture unless they are configured to be shown again Note Hidden objects will be treated in DataCapture as if they have not been defined For example hidden items will no longer be included in the form completion calculation or SDV status when saving again A form family that does not contain any visible forms will not be displayed in the patient form over view In the case of a saved form the recalculation of the status without the hidden items will only be performed after the form has been saved again In the Audit Trail the hidden items and questions will remain visible However they will be shown with a special highlighting frame The same applies for the listing of queries and comments In the query reports queries regarding hidden questions will be framed and highlighted just like in the list of queries for a form Form rules of displayed items can still refer to hidden it
27. the Audit Trail 6 11 Electronic signature optional Depending on the study an electronic e signature may be necessary to perform a save The save process can encompass the saving of medical data but it can also include actions such as reviews locking forms or creating comments queries or answers to queries By entering your userlD and password you are confirming that you Data edited UserlD Password Cancel Save Fig 63 E signature to confirm save The electronic signature always consists of the user s ID and password that are used for logging in to the system If an electronic signature is necessary to complete the save process the data which is to be saved and signed will be displayed You will then be prompted to enter your user ID and password to con firm the entries and the respective action If the user ID and password do not match with your data the action will not be carried out After entering this information incorrectly several times you may find that you are automatically logged out from the system and your participant account might be de activated If this happens contact your secuTrial administrator to reactivate your account If the electronic signature has been performed successfully the validity of the signature will be checked each time the respective form is opened If there is no valid signature this will be indicated in red letters at the top of the form The information contained in the last
28. the next defined visit in the order of the project which fulfils the treatment arm condition If both visits have already been created from one treatment arm all other visits of the treatment arm will be carried out without checking the treat ment arm condition again If visit groups have been defined for a project when creating the first visit of a repetition group all of the first visits of the group will be created After creating the last visit of a group when creating the next visit the option will be displayed to select whether the previous group is to be repeated or whether the next visit is be created according to the project plan This selection option is offered if the maximum number of repetitions for the visit group has not yet been reached If more visits are permitted in the project visit plan template than have been pre defined the last visit will be repeated You may also be able to create visits in a non chronological order The internal numbering of the vis its will then follow the order in which they are entered In the form overview they will be displayed in strictly chronological order For every new visit a new form set will be provided which can be opened using the corresponding symbols The forms belonging to each visit are already provided within the system Unplanned visits are created independently of the planned order For each defined unplanned visit you can specify the maximum number that can be created If the
29. use the selection list on right hand side in the frame around the form symbols This will only be displayed if the patient has been entered into multiple part projects and you have been assigned to these projects 4 7 Review locking data freeze secuTrial offers various ways to support the data management work flow which is typical in medical studies This includes locking patient data after data entry has been completed and enabling various reviews to check the data before releasing it for further processing The first review can be performed with the Review A button for each individual form or for an entire visit The review can be revoked with the REVOKE Review A button A second review can be performed with the Review B button for each individual form or for all of the patients within a project i e all forms from all visits including the status form of the patient in the current project A review B can be revoked through a query When performing a review any data changes that are made will not be saved If you have the right to both change data and conduct a review you will be reminded of this accordingly in a notification underneath the buttons The final locking of a form is performed using the FREEZE button for each individual form for each visit on the form overview page or for the entire patient all forms of all visits including the status forms of the patient in the actual project as well on the form overview page h
30. you will see a SAVE CLOSE ENTRY button when editing forms Use this saving procedure to declare data entry to be complete for this form and to release it for further checking If the data entries have not been completed but the entered data needs to be saved use the Save button If none of the entered data is to be saved click on the CANCEL button When DEC is activated the following form functions will only be available after the data entry has been completed Source Data Verification Review A Review B Queries As soon as the data entry in a form has been completed no further data entries or changes are per mitted in this form Only after a query has been created regarding a particular question is it possible for the form to be edited by a participant with the additional right to MODIFY ENTRIES Questions without any queries will remain unavailable for editing If data needs to be changed after a DEC has been set and a query has been created when saving the form a reason must be given for changing the data This will be saved in the Audit Trail In the Audit Trail data entry completion is recorded as Data entry completed and subsequent data changes as Data modified Should you accidentally click on the DEC button click on REOPEN ENTRY to quickly and easily re enter the data This function can only be used as long as no review has been conducted and provided the form has not been locked Furthermore there
31. 29 CEST aj Radiobutton 6 Value exists 60 Value not collected due to rule 10 Other entries 69 Value not collected due to rule Fig 31 Example of an MV history with entries changed relating to the MV status 4 3 Create a new visit To enter data for a new visit click on the NEXT visit button If different visit types are specified scheduled and unscheduled in the visit plan template for the present project you now have the option to select the required type Note 14 10 2010 13 10 CesT E Greifswald Oww C r i Pr Dr Jonas 333004 secu Fla DYMID 14 10 2010 13 10 05 CEST PatientLogin Edit isitplan Patientfile Mew patient Select gt Next visit Please specify ifthe next visit a regular or unscheduled visit in compliance with the study protocoll Unscheduled visits are ignored during the generation of the regular visit plan Scheduled visit 4 visit Unscheduled visit 1 visit dmm Date ho 4 2000 CETICEST Cancel Dave Fig 32 Input field for the visit types and date of the next visit For scheduled flexible free and unscheduled visits you now need to enter the date of the next visit In the case of scheduled fixed visits only the new date will be displayed and there will be no option to enter a date If treatment arms have been defined for a project when creating a patient only visits without a treat ment arm will be initially created The next offered visit will be
32. E After they have been created the forms will be listed according to these three aspects in three rows in the order they were created 14 10 2010 13 28 CEST Greifswald DYMD a Pr Dr Jonas aaa009 secu Fla DYMD 14 10 2010 13 28 00 CEST Patient Login EditVisitplan Patientfile New patient Select gt Visit plan AE Begleitmedikation Images Ol Imageform ol Imageform DMD Fig 42 Form overview of created image forms with thumbnails miniature view of the image im When creating an image form the time it was created and the participant will be saved and dis played You can create as many different image forms as you wish The choice of possible image forms is defined by creating different forms in the image family in the FormBuilder If the open form is not saved after selecting its assignment and image form this assignment information will not be saved Once forms have been saved they cannot be deleted and their assignment cannot be changed 4 13 Filling out or editing forms E Click on the corresponding symbol in the form overview to open the form you wish to edit 28 03 2013 13 51 CET paxb55 xp18 PM 15 03 2013 CET 5 o Standard 28 03 2013 11 50 27 CET Inclusion Exclusion S e C U r l d xP Inclusion Exclusion Import Inclusion Comment 1 Subject is gt 18 Years old yes Ono id 2 Written informed consent present O yes Ono gi EXAMPLE disease present O yes Ono 4 Subject is willing a
33. ICOM viewer is not suitable for diagnosis purposes In addition to the Save PRINT and CANCEL buttons forms optionally contain the following functions depending on the project configuration and your assigned role 6 1 Imports An import function is offered for uploading digital measurement data from medical equipment into the DataCapture forms This function is only possible for forms that have been configured accord ingly List parsers variables values in one line each and CSV parsers variables in the first line values in the second line can be used Proceed as follows 1 Click on IMPORT in the main menu top right of the form into which you wish to import the data A new pop up window will appear 2 If more than one import format is offered select the required format Choose the file you wish to upload 3 Next select the visit into which you wish to import if this has been defined for this project If the project was set up so that the visit must already be entered in the import file this step is omit ted 4 Click on UPLOAD to start the import Alternatively click on CANCEL to discontinue 5 In a separate window the result analysis will be displayed The analysis shows the number of assigned fields the number of unassigned fields and the number of fields that were unable to be assigned or were ignored because of variables or format errors 6 On the basis of the error overview you can decide whether you wish to perf
34. If a query is revoked and this was the last valid query on that element the Hide rules will be evalu ated again Data entry and editing with missing values MV Display and editing For all items configured with the function Missing Values MV an icon is displayed next to the entry field see below Clicking on this icon opens the popup window for setting the Missing Value status Performing this action only requires the editing or modify right after DEC or the revalidation right for the form All MV statuses will be saved simultaneously with the form data No separate entry will be made for this in the audit trail The MV status is saved in a separate database table Entries will only be cre ated for all values defined as not collected or missing When opening a form for the first time all MV statuses are set by default to Value exists When editing the form you can indicate that a field has been intentionally left empty by setting the MV status to Value not collected The following options are available Icon Label MV status W Value exists Value not collected 9 Value not collected due to rule only set automatically Other reason for missing value optional with free text entry When the form is saved all items for which a value exists will automatically be set to Value exists For items without a value and the entry Value exists an error message will be displayed stating that either a value mu
35. Product description of the various form families listed under neath each other to the left of the window A form family can contain one or more forms If a form family contains only one form open it directly by clicking on the symbol for the form family If it contains several forms an overview of the forms will be initially displayed at the foot of the page below the window To close this click on the form family symbol again To open a single form click on the corresponding symbol below As a rule the individual forms can be opened and edited in any order However please note that due to participant role rights in certain circumstances not all participants will be able to view open or edit all forms In the form overview only the form families containing forms which are available to you for viewing will be listed If this is not the case the form family will be hidden The HeLP button in the form overview will provide you with an overview of the displayed icons and functions see Chapter 4 5 In the DataCapture header your name project date centre and the pseudonym s must be cor rectly displayed Navigation buttons with which you can return to the Welcome page WELCOME or log out of the system LoGouT can be found at the top right of the main menu page If you wish to change to a new patient enter the respective pseudonym in the input field at the top right of the main menu Click on SELECT or press enter on your keybo
36. T Print Discrepancies lt All gt y lt All gt x lt All gt gt lt All gt y lt All gt gt lt All gt gt lt All gt lt All gt y kA lt All gt y D gt 1 341 2 02 03 07 hsf382 Greifswald D YMD 302 Begleitmedikation Medication dose 03 05 10 Pr Dr Jonas query created gt 1 2 02 03 07 aaa009 Greifswald DVMD 466 Demographics Sex 14 10 10 Pr Dr Jonas new D1 2 02 03 07 aaa009 Greifswald D YMD 466 Demographics Ethic group 14 10 10 Pr Dr Jonas new b1 2 02 03 07 aaa009 Greifswald DYMD 466 Demographics Comment 14 10 10 Pr Dr Jonas new D1 2 02 03 07 aaa009 Greifswald D YMD 466 Demographics Body weight 14 10 10 Pr Dr Jonas new D4 2 02 03 07 aaa0og Greifswald DVMD 466 Demographics Body height 14 10 10 Pr Dr Jonas new Fig 13 Overview of all discrepancies s All newly created discrepancies are shown with the status new In the advanced view you can change the status of a discrepancy or create a query using the available options E In certain cases you may only be able to edit discrepancies to a limited extent This is the case when you do not have the DTM right authorisation for the centre that belongs to the discrepancy This right is assigned in the AdminTool a query has already been created for a discrepancy In this case you will not be able to create a new query and the discrepancy can no longer be edited However you can skip directly from the discrepancy to the created quer
37. The secuTrial version label of the productive project has already been displayed in the status header If a participant is dedicated to multiple project versions via different centres the project will not be shown in the status header on the Welcome page Only when a distinct patient and thereby a centre with a distinct assigned version has been selected this project version is displayed by name and label in the status header On the selection of an report the version of the related project see fig 61 will be displayed in the report window status header Data Entry Forms Visits New patients will be included with the project version of the selected centre The display and all properties of visit plan and forms are defined completely by the version of the current centre If a participant can include and edit patients in different project versions if he is dedicated to multiple centres using different project versions If the centre version is changed afterwards or the patient is moved to another centre using a different project version the version of data entry can be viewed in the Audit Trail of each form Existing visits in patients are not changed by a change of the project version The new project visit plan configuration only applies to the creation of new visits During the save of a form the current project version of the patient s centre is used for data entry as well as for data check of entered data In the database all references
38. User Manual secuTrial DataCapture Valid for version 4 7 As of 13 10 2014 interActive Systems Berlin le o A 4 1 1 System FEQUIFGIMC INS iis caia a aio 4 1 2 General user INTOMMANON reisocinali a ii id ocre 4 A A CO E E AA 6 ee A E A oi PA 6 22 Change PassWord AS nn A 7 3 io coo A a Un nn o o A 8 3 1 Qualification test OptiONATI o cccccnncccononoconnnocononononoconononononononnnnonannnnnonononannnonannnnnnnnnnanennos 8 3 2 Message UNC oO Rial ee ota 9 3 3 Reports and Stalin cr istada 9 nn on A 9 RUS UG A UA PI o AA 11 34 My ACCOUNE optional iO REELE 11 36 Downloading Oplona Desssciacio ria 12 3 6 Creating and editing new patientS ccoconcncconcnncccnnccnccnnnnnnnnoncnnonannnonncnnnnnnnonnronannnnonrnnnrenannnnos 12 3 7 Mass Import OF TOM dalas n aan tara 12 Mass import for a single TON acids cette daira cemeantacteae NEEE AE AEREE REENEN 13 Mass Import TOF multiple TO MS estais 14 3 8 Discrepancies Transfer Module DTM occoocccccccnnccoconococncccocononononononononnnnnonnnnnnnnnnononnnnnanenanenens 15 MPoring discrepancies espa pti 16 0 polo ae EO EE E ENEE 17 E M Oe o E seanes enccuanemeouscmnadaseenaee 18 FS VINO ANI OP A E EE E E E E O E 21 d Emong patent data soles a a EE AE E E E 22 4 1 Adding a new patient to the database cooccconccconnccncnconcnconcnnnncnnnanonnnnnonnnnonnonnnonnnnrrnrnnrnnnnnannnos 22 Patient in Single Cenie nurse iii ins 22 Summary steps f
39. a structure If the earlier version consists of less forms or items all data entered in those fields could no longer be displayed e This also applies to all entered queries and comments on those items The data will not be displayed in the Audit Trail either They can nevertheless be exported completely 5 The form status remains unchanged in the state of last save action The status could even differ from the displayed data e g if the single query was set on a now undisplayed item Only at the next status calculation at the respective form action only the displayed data are respected This beha viour is similar to the behaviour after the normal release after a normal set up extension 5 The e signature remains valid after version change because the e signature is always validated against the version used during save 6 10 Audit Trail z The Audit Trail provides an overview of all changes that have been made and saved in the current form It can be accessed after the form has been saved for the first time To view the Audit Trail click on the AUDIT TRAIL button in the main menu at the top right of the page Date 14 10 2010 15 17 EST Patient Patio 339009 iB Close Clinical Investigator Pr Dr Jonas 1 visit 01 01 2000 CET l Project DyMD 14 10 2010 15 06 50 CEST Form family Demographic Frint m Centre Greifswald OMEO Form Demographics Audit Trail Demographics Document Mo 466 Document History Signed by at Signature me
40. al possible answers Click on the arrow to open the list and then on the applicable answer in the list Ethic group lt Please choose gt i lt Please choose Caucasian african asian 5 2 Combined form components In extended dropdown lists you have the option of adding your own entries in a second list if the provided options are insufficient This is done using the OTHERS button An additional entry field will then appear to the right where you can create the new entry This will be adopted into the second list by clicking on the small triangle or saving the form You can also choose an entry directly from the list Click on the SELECTION button to return to the first list on the left The first list contains all possible answers created in the project design The second list contains all additional entries added by you or other users Additive drugs antidepressant T p birth contral pill gt lt Please choose gt Selection j Hierarchical dropdown lists build on each other The selection you make in the first list determines the selections that are available in the following list Medication Applied medicine Applied dose none gt dE Please choose 21 05 2010 11 51 47 Medication Applied medicine Applied dose Aspirin y lt Please choose gt iy Pr Dr Jonas ae EE 21 05 2010 11 51 47 tablet CEST tablet In the laboratory value input fields measured data can be entere
41. always point to the productive project This applies to the form references as well as to the item references for queries comments or SDV This is necessary because the database IDs of the productive version remain constant whereas the database IDs of the project set up are created new for every archive version If a message is triggered by a plausibility check form save or query editing the message can only be delivered if the same message is defined in the productive version of the project The dispatch goes by the defined recipients for the productive project in the AdminTool see restrictions and exceptions Document History Audit Trail In the Audit Trail respective the document history of every form the project version is already dis played beneath the participant date and reason for storage The listing of the document changes goes by the currently used project version of the patient s centre If for example the data has first been entered with the productive version and then the centre changed to an older version data of items not yet existent in the older version cannot be dis played This behaviour differs from the hiding of items where the hidden data is displayed neverthe less and marked up by format as being hidden Reports and Statistics In the report overview all reports will be listed where the participant role has sufficient rights given on the productive version of the report If the participant only have access to
42. aning Validity Project version Pr Dr Jonas 14 10 2010 15 06 00 CEST Data entry completed signature valid 14 10 2010 14 47 24 CEST Pr Dr Jonas 21 05 2010 11 51 47 CEST Daten eingegeben Mot signed 21 05 2010 11 42 34 CEST Pr Dr Jonas 21 05 2010 11 43 14 CEST Daten eingegeben Mot signed 21 05 2010 11 42 34 CEST Changes in document Pr Dr Jonas 14 10 2010 15 06 00 CEST Date of birth Sex not applicable Body weight Body height Ethic group Comment Blood sample taken no Additive drugs Randomize E Pr Dr Jonas 21 05 2010 11 51 47 CEST Date of birth Sex not applicable Body weight Body height Ethic group Comment Blood sample taken no Additive drugs Randomize PrOr Jonas 21 05 2010 11 43 14 CEST Date of birth Sex not applicable Body weight Body height Ethic group Comment Blood sample taken no Additive drugs Randomize Catalogue Pr Dr Jonas 14 10 2010 15 06 00 CEST Diagnose ICD 10 ICD additional Pr Dr Jonas 21 05 2010 11 51 47 CEST Diagnose Katalogtest 27 05 70 77 30 ICD 10 ICD additional Pr Or Jonas 21 05 2010 11 43 14 CEST Diagnose Katelogtest 13 05 09 10 46 1CD 10 ICD additional Medication Pr Dr Jonas 14 10 2010 15 06 00 CEST Applied medicine Applied dose Pr Dr Jonas 21 05 2010 11 51 47 CEST Applied medicine Applied dose Pr Dr Jonas 21 05 2010 11 43 14 CEST Applied medicine Applied dose Medication Pr Or Jonas 14 10 2010 15 06 00 CEST Pr Dr Jo
43. ard Entering and editing with patient in multiple centres For editing and viewing patients if you and the patient are in more than one mutual centre a centre must be selected in each case In such situations the selection can be changed in the form overview of the patient via the centre dropdown list see highlighted area in Fig 22 gt 15 08 2013 18 00 CEST Bonn Dipl biol Susanne Schneider yood 65 secu ria Example study 15 08 2013 18 00 24 CEST Patientlogin EditVYisitenplan Label Patientfile New patient Select gt Visitenplan Label Adverse Event Casenode Casenode 2 Casenode 3 Bildverwaltung Bonn Berlin Unscheduled Bielefeld Baseline treatment Neuer isi Visiteneintrac Planned visits 11 06 13 25 06 13 Salil Data entry 26 07 13 26 07 13 al ol owl Visitenformulare Visitenformulare 2 Print letter Print letter Patient visit O vi visit Fig 22 Form overview for a patient in multiple centres dropdown list and centre specific visits For all centre specific visits the form icons will be displayed in the form overview of the patient for all centres However viewing and editing visit forms is only possible for the participant of the owning centre For all other centres these visits will be shown against a grey background see Fig 22 When opening the form family a warning message will be displayed accordingly Entering and editing with double data en
44. at a time per centre In the case of consecutive numbering per project only one patient can be created at a time in the entire project All other participants will receive notification accordingly For the duration of the editing lock the session timeout for the participant who is creating the patient will be temporarily lowered to 5 minutes This means the system lock time for other participants will also be reduced to this amount of time if the participant does not properly complete the process of creating the patient e g simply closing the browser The system lock will then be deactivated after the session has expired If the system lock is deactivated by cancelling the editing process changing the project or centre for creating the patient or because the session has expired the next previously displayed number will once again be available and can be used to create the next patient in this centre or project This guarantees consecutive numbering without any gaps a a 28 03 2013 12 43 CET Systemtest 441 28 03 2013 12 42 20 CET secuilrla PM Ready New patient Project Systemtest 441 28 03 2013 12 42 20 CET Centre Ready Additional patient ID Add ID AOO1 Create Visit plan Please enter date of entry first visit as the basis for the visit plan Entry date 28 103 L12013 dd mm yyyy CETICEST Cancel Save Fig 18 Automatic assignment of Add ID with numbering per centre If the use of centre prefixes has been de
45. at random single or resulting status ol verified The verification has been finalized and there were no differences The resulting status could include some items where the verification was not necessary single or resulting status Fig 55 Overview of all SDV status symbols Every item has an SDV history This is displayed in the pop up window for changing an item s SDV status The SDV history of all items within a form can also be accessed via the SDV History button in the form view Click on PRINT to print the history or CLosE to leave the window Changing the SDV status of the items in a form is recorded as Source Data Verification in the Audit Trail Changing the SDV status at the form level 14 10 2010 15 22 CEST aaa009 B Pr Dr Jonas 01 01 2000 CET sal DYMD 14 10 2010 15 06 50 CEST Demographic Secu Fla Greifswald DVMD Demographics L SDY History Queries Comments Audit Trail Print Demographics Document No 466 3 Date of birth D 7 EETA Comment Q Sex O not applicable O male O female rt Body weight kg Body height a cm Fig 56 Changing the SDV status of an item To change and save the status of an individual item click on the round symbol next to the respective item A pop up window will open for you to select the applicable SDV status To save only the indi vidual status change select ONLY INDIVIDUAL CHANGES from the dropdown list below the form set SDV for form onl
46. atification factors for the patients must be available If a blinding process is to be performed see below enough unused randomization numbers must be available for the patient s centre If the form with the randomization button has been explicitly marked for randomization no button will be displayed on the form Instead the randomization will be performed when saving the form and a message will be displayed in the form accordingly In all other cases the randomization will be executed and saved immediately after clicking on the button If the randomization cannot be performed e g because the stratification factors have not yet been saved an error message will appear If the randomization has been successful instead of the button the respective randomization group or number in the case of blinding will be displayed together with the remaining number of available randomizations see messages In addition to the separate storing of the data the randomization will also be saved as a form item For randomization forms the randomization group or number will be displayed on the interim page together with the save message The randomization is displayed in the status header and in the form All randomizations are dis played in the status header when implementing multiple randomizations within a project using vari ous randomization buttons Blinding If blinding is configured for a project only the randomization numbers will be displa
47. ave to activate at first a necessary Java plu gin in your browser Before uploading the selected images the file will be given a pseudonym in the DICOM header and in the DICOMDIR The name of the patient will also be replaced by the secuTrial pseudonym The date of birth will be set to the first of the month To upload DICOM images or a series of images open the Dicom file selection dialogue using the Dicom Browser The respective link can be accessed by clicking on the UPLOAD button in the form Image upload Upload an image file AA Or open the Dicom file chooser ECETIA Dicom Browser Fig 49 Upload DICOM image opening the Dicom browser The Dicom browser will then open Select the required DICOM images from a CD or your file sys tem Multiple selections can be made by holding down the CTRL key The Dicom browser is a Java applet which is executed in the browser This applet is signed for the provider interActive Systems Gesellschaft fuer interactive Medien mbH with a code signing certific ate of the publisher Thawte www thawte de Depending on the Java version installed on your device and the local security properties you might have to activate the Java applet in a first step and also allow the execution of the program named DicomApplet m choose File Filesystem Patients show Image preview slower Patient Name Patient ID Study Desc Date Time Preview i F Schneider Susa 2064 GELENK 04 04 06 DICOM CD
48. ay the test overview You can open the test form by clicking on the test form icon Several test attempts can usually be performed this number can be con figured for each project After correctly answering all of the questions you will be able to access the data entry start page by pressing the EvALUATE TeEsT button If you have not achieved the necessary number of points dis played at the end of the test you can return to the test overview page and perform further attempts In this case only the results will be saved Your answers won t be saved and they will no longer be available for viewing Once you have answered all of the questions correctly you can access the data entry start page by pressing the CONTINUE button Message function Certain events that occur when saving a form will automatically generate messages that are sent to all potentially interested individuals e g if an adverse event has been registered or if a patient has passed away Additionally secuTrial offers a simple messaging function for personally exchanging information within the system Depending on the rights assigned to your role you can use the message function on the start page Click on the Messaces button to write send and read messages You can also view new and old messages To write a message and send it you must first click on the SEND NEW MESSAGE link Select the recipi ent group write the message and the message title and then click on Sav
49. centre in common the patient will be listed in that centre If you and the patient have more than one mutual centre in common and you have the rights to the report via the centre role the patient will be listed in the centre in which he or she was first created With SQL reports the report definition determines whether a patient will be listed and if so under which centre If additional centre assignments are to be listed and not only the home centre these must be joined via the tables Patient Ctrpatient Centre The link between Centre Casenode only represents the home centre of the patient In projects with treatment arms status and icon reports list the patients from different treatment arms separately if the report is sorted by visit type You can select whether the report should be sorted according to treatment arms or centres The display can also be filtered according to treatment arm In projects with centre specific project versioning it is not possible to choose between sorting by centres or treatment arms For each centre the project version that is applicable for this centre will be used to evaluate and display the report data If the report definition is changed this can lead to the single field and status displays being mixed within a report If a report is defined as hidden for all of a participant s centre versions the report will no longer be listed in the report overview If a re port is defined as hidden only f
50. changed visit date e To change the visit date and visit type click on the link EDIT visit PLAN link name may vary depend ing on configuration e Unplanned visits are not affected by changes to planned visits They can be independently shifted After changing a date or a visit a new visit plan will be calculated and checked against the visit plan for the project Any errors will be displayed Only visit plans that comply with the configuration can be saved 14 10 2010 13 18 CEST Greifswald DYMD T i Pr Dr Jonas aaaoog secu Fla DYMD 14 10 2010 13 14 31 CEST Patient Login Edit isitplan Patientfile New patient Select gt Edit Visit plan Show history As long as there has been no data entered yet into a visit you can change the visit date You can only change one date at a time All subsequent visits will be shifted accordingly For unscheduled visits you can change the visit type too Entry date 01 01 2000 CET 1 visit 01 01 2000 CET 2 visit 13 01 2000 CET Edit 3 visit 12 04 2000 CEST Edit Cancel Reset Preview Fig 34 Page for editing the visit plan and viewing the history s To save a change in the visit plan a reason must first be provided This will be listed in the visit plan history e Even if it is not possible to edit the visit plan you can still view the history from the Edit Visit Plan page assuming changes have been made n a 14 10 2010 13 19 CEST Greifswald DYMD
51. close the window by clicking on the CLOSE button Certain reports can be downloaded as Excel files by clicking on the ExceL button Under the Pat ID column and depending on the configuration also via Add ID or Lab ID patients can be selected for viewing and editing The form overview for the selected patient will then appear in the main window see chapter 4 2 If the document ID of a form is listed in an SQL report the form can be directly accessed using this ID If the current participant does not have the right to view the form an error message will be dis played instead An error message is also displayed if the document ID does not refer to an existing valid form Reports and statistics are not displayed for inactive projects In closed projects these continue to be displayed Statistics After selecting an individual statistic it will open in a separate window and the number of patients with a defined data criteria will be graphically displayed These are summaries of patient data and do not show individual patients After viewing statistics can be printed with the PRINT button To close the window click on the CLOSE button The data can be exported to Excel by clicking on the ExceL button 3 4 My Account optional Click on the My Account button to view or change your participant data Your data will be automatic ally updated in the AdminTool In addition to the regular participant data you can make the following settings
52. completed participants with the respective rights can perform a verifica tion of the existing data If the participant does not have the rights to perform an SDV the SDV status will be displayed but cannot be changed There are five different types of SDV Status that an item can have However the status can only be reset to not done for individual items If all items in a form have the same SDV status this status will be adopted for the entire form and displayed in the form overview If the items each have a dif ferent status the form will be given a symbol to reflect this The same procedure applies for form families visits and the whole patient Click on the HELP button in the form overview for explanations of the various SDV symbols not done Mo verification has been made on this item or form single or resulting status 4 In progress some items has yet not been verified or are deferred So the verification Is still in progress resulting status 2 deferred A final verification is not possible at the moment Perhaps a difference has been noticed which must be cleared single status e not possible The original data has gone lost or a difference could not be cleared So a verfication could not be done single status 4 verified with errors SDW has been made but for at least one item it was impossible resulting status al not necessary A verification of this item or form is not necessary e g when the SOW is only tested
53. count Messages Import Reports New patient Select Import of form data Project Example study Import configuration Visit date This is a first test impor configuration Select the file for upload Durchsuchen Keine Datei ausgew hlt ISO 5B59 15 Upload Fig 7 Selecting the import configuration for an import in multiple forms In the import file data it is possible to simultaneously import data for visit forms adverse event forms and casenode forms However it is recommended that these different form types are imported sep arately see Fig 8 and Fig 9 When importing it is also possible to create new patients visits or adverse events if this is permitted in the import configuration This is possible without entering form data Fig 8 Example file for visit forms including repetition groups in scheduled and unscheduled visits Fig 9 Example file for AE forms including repetition groups and follow up examinations 3 8 Discrepancies Transfer Module DTM a To ensure data quality in studies data is often checked for deviations from expectations discrep ancies using external tools The DTM enables you to integrate the results lists of these checks into the secuTrial system After importing the results lists you can check them manually and convert them into queries To use the DTM in DataCapture the necessary user rights and functions must first be assigned in the CustomerAdminTool AdminT
54. d in various predefined units In the secuTrial database they are always saved in the same reference units The converted value is dis played next to the input field if a unit other than the reference unit has been selected circled Natrium lt Please choose gt Natrium lt Please choose gt my He 2 2658 mmol Norm mena ma cl e By using the RANDOMIZATION button you can divide the patients into two random groups After clicking on the button pictured on the left the selected random group will be displayed in place of the button pictured on the right The randomization is performed as soon as you click on the RANDOMIZATION button and cannot be reversed even if you do not save the form This prevents the randomization process from being bypassed by cancelling and reopening the form If you do not save the form the information will not be contained in any of the reports The randomization group of a patient is shown next to the pseudonym in the header Randomization gt Assigned to group B 5 3 Scores Evaluation fields scores show the results after clicking on Score If the form has already been saved the saved results will be displayed when you open it Clicking on Score will perform an updated evaluation with the current scores RR systolic fi23 diastolic fiza Score P Score 246 All scores in a form are calculated by pressing the CALCULATE scores button at the bottom of the form The
55. data In this case an adverse event won t be created B When you return to the form overview page you will see that the ADVERSE EveNT tab will now have a different colour This enables users to immediately see if an adverse event has been added to the patient data A correspondingly coloured symbol on the adverse event form overview enables you to conveniently access the respective data details A new event can be added by clicking again on the NEw ADVERSE EVENT link i You can create a follow up examination for an AE or SAE by clicking on the New FoLLow uP link You will be once again be asked to enter the date of the next examination for this event It is not possible to create a new follow up after completing the follow up examination for this event AEs and SAEs are displayed with different coloured symbols and different coloured form overview frames Furthermore in the form overview an event tab will be displayed in place of the usual visit plan tab when a patient with at least one SAE is viewed 4 12 Image families i If the Image form family type has been defined in the FormBuilder an additional tab with the name of the form family will be displayed in the form overview z The forms in this form family can also be created using the New IMAGE FORM link This is similar to the process for creating AEs When creating a patient these forms can be assigned to a specific already created visit or to the examination of an existing A
56. e Ok jzq20o 0 Formulare argUs6 10 Formulare iqeols 4 Formulare Ok 4 visit OST Test gt gt gt gt jbtobd 1 Formulare Ok gt gt Ok visit First Examination Ok 2 2 2 wisit Histology 2 visit Laboratory cn Begleltmedikation Ok Ok dl hehh 5 Formulare Dk S DST Test Histology Laboratory gt Not editable Patients O First Examination Ok Mot saved torm i Ok Mot saved form Ok i k k k 0 Mot saved form Mot saved form Beglettmedikation Ok Not saved form Mot possible 1 Mot possible Not possible 1 Mot possible 1 Mot possible Cancel Save Review Download Logout By clicking on the Save Review A button labelled with the corresponding action the action will be carried out and saved If necessary the e signature must be entered first A progress bar will be dis played while the action is being saved In addition the results list will be displayed in advance listing all executable patients and forms The final result of the individual form action will then be gradually updated seculrial Welcome ate 29 01 2013 14 47 CET articipant Dipl biol Susanne Schneider Mass Action Result Result Review A Duration of processing 00 00 P Edited Patients 8 Ok O Not possible 0 After the action has been completed the progress bar will disappear and the buttons will be dis played The result o
57. e datasets with warnings will be imported into the form and saved If the form has been locked due to missing rights and or subject to certain conditions this will be displayed as an error in the import results 10 Datasets that have been imported despite warnings in the analysis will be listed in the results list under Warnings The same applies for datasets which were saved with errors or warnings resulting from the plausibility checks in this form during the saving process 11 After analysing and performing a mass import a summary of successful datasets and datasets with errors or warnings is displayed In addition to viewing the analysis or import details it is also possible to download the datasets again as a CSV file When downloading you can select a character set so that the CSV file can also be downloaded into other character sets as UTF 8 12 In the Audit Trail the imported data will be marked as Data imported after saving If the function patient in multiple centres has been configured in the FormBuilder after selecting the project the centre must now also be selected for the import when performing the mass imports The additional option all centres is available if you are allowed to conduct a mass import into more than one centre If you have only the necessary rights for one centre it will be automatically selec ted If the option All centres is selected for patients in multiple centres the import will be c
58. e laboratory ID Lab ID and an additional ID Add ID see below The sec uTrial database uses only these pseudonyms The personal data of the patients is not saved or transferred to the secuTrial server To add a new patient click on NEw PATIENT at the top right of the main menu If you are a participant in multiple centres or projects you can select which project or centre the data should be attributed to The structure of this page depends on your user rights and the projects which are available to yOu If you click on the New PATIENT Button from the form overview page of a patient the current project and centre are already selected However you can also select other options If in addition to the secuTrial pseudonym an additional identifier Add ID has been envisaged for the project to which you wish to add the patient depending on the configuration on the selection page for the centre a text field will appear into which you must enter this ID the Add ID must also be unique for all projects of a customer Alternatively if the Add ID is to be consecutively generated depending on the configuration the next available number for the centre or the project will be assigned To prevent gaps in the automatic consecutive numbering of Add IDs caused by cancelling the pro cess when creating new patients an automatic system lock has been introduced In the case of con secutive numbering per centre only one patient can be created
59. e patient s User ID login URL In the second email there is a link with which the patient can choose a password password reentry URL The link is valid until the patient has chosen a password a For data privacy reasons the patient s email address will not be saved in secuTrial It is therefore only possible to send notification emails manually The same function is available in the AdminTool which also enables the project administrator to manage the patient s login access Above the email links you will also see a link for opening a print preview of the information that has been sent This page can be printed out for your records or it can be given to the patient Depending on the assigned role rights the patient can now view his or her data in the form overview and read or edit the forms It is not possible for participants and patients to enter data at the same time Once a form is being edited it will be locked for all other participants patients See manual for patients Once the patient has set up the login and logged in to DataCapture for the first time access enabled will be displayed in the overview A message will be sent to the centre s email address stating that the patient has successfully logged in s If a patient is contained in multiple centre see Patient in multiple centres and patient self docu mentation is used for the project the patient can also be assigned different patient roles in all of his or her assig
60. e to send the message After logging in to DataCapture all new messages addressed to you will appear in a pop up window With the CONFIRM BUTTON you can mark a new message as read In the message menu you can also view new messages as well as messages that have been previously read or sent at any time 3 3 Reports and statistics If you click on the RePORT button in the main menu you will obtain an overview of all of the reports and statistics created for your project which your rights permit you to view The preferred report that has been defined for the participant editable in My Account Preferred Report will be displayed as an additional menu button on the Welcome page Form Overview page and Form page If you click on this button the preferred report will open in an additional pop up win dow and can be used to navigate between patients Directly after logging in your preferred report will immediately open in a pop up window If you only wish the report to appear as a menu item option you can configure this accordingly in My Account Reports After selecting a report by clicking on its title it will open in a new window together with an overview of all the patients or results for your assigned centres One entry line is usually displayed for each patient included in this report Reports are always displayed in a separate report window which is independent from all other win dows The report window remains open even i
61. e you try to leave the form during editing via a general navigation link a report or the browser navigation functions A pop up will be displayed requesting a confirmation for form leave If the confirmation is negated the action will not be executed and you will stay on the form page The confirmation is only displayed if you has the editing or modify right for the form and the form is at least partly with an non closed query after DEC editable If the server does not register any activity for a long period of time your session will automatically time out This guarantees that no unauthorised persons gain access to the database and can change your datasets Activity on the server means saving or changing form pages but not just entering data in a form The exact time until timeout is configured on the secuTrial server and is usually 20 minutes The remaining time until the session timeout is displayed in the title bar of the browser window lf your session automatically times out any unsaved data may be lost If you interrupt your work at any point you should therefore make sure you save the form on which you are currently working with the Save button Most pages in DataCapture have a help function which you can open by clicking on the HELP button in the main menu at the top right of the screen For orientation the current user s data is always displayed in the header of all secuTrial pages PA seculrial web based data capture
62. eeeeeeeeesaeeeeeeeeeees 32 Bai e o II AA 32 Mv ana rule val O seesinane EARE tetra 33 A A e o A e nn 34 A ee ee eee ee eee nan ae 34 4 4 Changing an existing VISIE ooccooncccconnccncocnncconnconoconnnnnnonnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnrnnrnnnnrnnrnnnnnanos 36 Changing a o AIN M e A A 36 BSS UNC WU aora eiii 37 45 Status and gS 9 arenie en ee eee ee eee ne 37 AG Pree o A A A 38 4 7 Review locking data freeze ooocccconccoccnncocononononononnnnonannnononononannnonannnnnnnnnanonnnnnnnnnnnanenanen 38 4 0 Patient ACCESS OPlONAal Jusnccionsicdsrcsimsi iana aa daa aa aAa Eia 39 4 39 Patent letter ODUOMAl cisctecriexdsedidseraaisesands easee scauureddedecunnedodtushovsenniedallveiseeddauddessseusdeadeeacsesosnect 40 AA A e ibaa dona AER 41 Barcode print for DSCUGONYMS cccceeceececeeeeeeceeeeceececeeeeseeeeseeeeseeesseeessesessuseseueeseeeeseegees 42 ATI PROV TN AAA P A 42 AAD Image TAMING S st as 43 413 Filling OUL A aadi 44 NOLES ON MINO TOMS our a iiontdtab coito nel 44 PIausiDllIy CNet llo casi eE 45 Summary steps for entering data into OrMS ooccccocccccnocnncnccncnnannnnnncnnnnnnnnnncnnononnnnrnnonannnnnns 46 lA E Pm 47 Dal BASIC TOA CIN UN adictas 47 5 2 GOMDINE form COMPONEN cnica ind 47 A O A 48 o4 A A ns 49 0 0 IRGDCINOMOIOUDS lidad 51 90 Uploading MATOS anita ii Da ia 52 9 Uploading DIC OMUMaG 6S atacada iia 53 ON IM MU CUOMS ars dd vedicegenthacsaut
63. either browse through the catalogue entries or search for a specific term You can define your search in the upper area of the window In the middle area you can choose which columns of the catalogue are to be displayed In the lower area you will see the chapter head ings from the topmost hierarchy levels of the catalogue Click on one of the small triangles to the left to open the chapters and browse e g if you are not searching for a specific term Click on the triangle to the left of Display to open the display filter for the catalogue columns Using the checkboxes you can activate or deactivate the display for each catalogue column After perform ing a change the display must be updated by clicking on the SHow button on the right After this only catalogue columns marked with a tick will be displayed In the search field you can enter any search terms or letter combinations Searches do not look for complete words or word beginnings the entered letter combinations may occur anywhere within a word For example a search for the word ill could produce both illness and pill in the search results assuming these entries occur in the catalogue You can search for several words simultaneously if they are separated with a space Searches are performed for entries in which all of the words appear regardless of order No distinction is made between different letters or between capitals and lower case letters For example a search
64. ems as these are merely no longer displayed in DataCapture and have not been deleted from the database The following section contains extracts from example files for the DTM import and import formats 7 1 DTM XML format File type xml ungezippt File structure Entries in accordance with the discrepancies dtd as specified here lt ELEMENT file discrepancy gt lt ATTLIST file project CDATA FIMPLIED gt lt ELEMENT discrepancy testnr testdate testtablename testcolumnname testmnpdocid testpid testtext testinstruction gt lt ATTLIST discrepancy testdcnr CDATA FREQUIRED gt lt ELEMENT testnr HPCDATA gt lt ELEMENT testdate FPCDATA gt lt ELEMENT testtablename PCDATA gt lt ELEMENT testcolumnname PCDATA gt lt ELEMENT testmnpdocid FPCDATA gt lt ELEMENT testpid FPCDATA gt lt ELEMENT testtext RPCDATA gt lt ELEMENT testinstruction FPCDATA gt Entries Name Doublet search Type Format Width Meaning testdcnr Integer external ID of discrepancy testnr yes Integer external ID of test testdate Date dd mm yyyy Time of test run MEZ MESZ testtablename yes String 32 Name of affected table testcolumnname yes String 32 Name of affected column Item testmnpdocid yes Integer ID of affected dataset mnpdid testpid yes Integer ID of affected patient testtext yes String 1000 Test error message testinstruction String 500 Instruction to centre Example
65. en cannot be saved in the DDE comparison These forms will be listed separately in the overview Close Save comparison patient yqo680 For this 1 document the comparison shall be saved Ready y90680 ROO1 ODE Form 1 Startvisite 26 03 13 ODE comparison finished E Sighature By entering your user ID and password you are confirming that you DDE comparison finished User ID Password i Cancel Save Fig 26 DDE comparison pop up with entry of e signature if necessary If an e signature has been configured for the entire project or only for this function it must be entered in order to save the comparison When saving the comparison an entry will be made accordingly in the Audit Trail of the forms Afterwards in the form overview and in all other representations e g reports only the original dataset 1 will be displayed The second duplicate dataset is now only visible in the Audit Trail of dataset 1 It can be made visible or hidden in the document history and the document changes 28 03 2013 13 14 CET ygoB80 Roo mines Phil 26 03 2013 CET oystemtest 441 28 03 2013 12 55 55 CET Visite Print Ready DOE Form Audit Trail ODE Form Document Mo 151 Document History Pht 28 03 2013 13 13 51 CET ODE comparison finished signature valid 20 03 2013 12 55 55 Ei PM 28 03 2013 125436 CET DDE entry completed Not signed 28 03 2013 12 50 11 CET Phi 28 03 2013 12 54 31 CET DDOE entry Mot signed
66. enarios are conceivable depending on the various project configurations Answering queries without DEC 1 The query is created by the monitor regarding an incorrect item 2 The value is changed by the physician and the form is saved 3 The query relating to the value in question is automatically answered with the text Query auto matically answered due to value change Queries will only be answered when their item values are changed All other queries must be manually answered Answering queries with DEC 1 The query is created by the monitor regarding an incorrect item and the question may be edited 2 The value is changed by the physician and the form is saved 3 A reason is entered when saving Note 4 The query relating to the value in question is automatically answered with the text Query auto matically answered due to value change with the reason followed by the text explaining the reason for the change If data is imported regarding items for which a query has been created the query will be likewise answered automatically If editing a query requires an electronic signature this must also be entered for the automatic query answer even if it is normally possible to save the form without an e signature Both forms and quer ies will then be signed 6 3 Question based help function An additional function provided in the forms is the question based help function If available this is located to the
67. eport Withdrawn queries are not displayed in the form or in the editing pop up window Withdrawn queries are listed when printing the patient file with displayed queries In the case of queries created by the DTM participants also have the option to suggest a further checking of the entry for that query After selecting this option the status of the respective discrep ancy will be set to check again Print Close Guerny Document No 466 3 Demographics Date of birth Please enter your new query here Cancel Sign save Fig 54 Entering a query To read all of the queries in a form click on the QUERIES button in the main menu at top right of the page This function will only be available in a form after saving Click on CANCEL to return to the form or PRINT to print the queries If queries are created regarding items in a repetition group this group can no longer be fully deleted The DELETE button below the group if available deletes the data but not the actual group itself Once a query has been made on an item the item or enclosing question cannot be hidden and pos sible matching Hide rules are ignored The form element will still be displayed even if a Hide rule will evaluate to true after a value change Automatic query answering If the project has been accordingly configured in the FormBuilder the queries in forms will be auto matically answered if the underlying item is changed The following sc
68. ere FREEZE PATIENT Afterwards it is no longer possible to perform reviews and or create queries As a rule the prerequisite for manual locking is that the form or forms of a visit has already under gone a Review A and or a Review B For adverse event forms the respective adverse event has to be closed by rule creating of follow ups not possible If only a Review A is the prerequisite manually locking the patient s file also locks all forms with open queries Under certain conditions forms can also be locked automatically For example if it has been declared in an exit form that the patient no longer wishes to participate in the study a aturr 26 05 2014 18 35 MESS Berlin Dipl Biol Susanne Schneider epm318 Rani A Se C Li ria Basisregister 26 05 2014 18 11 14 MESZ Visitenplan bearbeiten Patientenakte Meuer Patient Ausw hlen gt Visitenplan Adverse Event Casenode Bildverwaltung 1 Visite 2 Visite 3 Visite Pen Geplante Visiten 20 03 14 30 03 14 09 0414 Eintrag am 20 03 14 20 03 14 26 06 14 i l p Visttentormulare o al E la hls o TE E E Brief Brief Brief drucken drucken drucken Review Revie F evie Review Patienten Visite Visite Visite Patienten sperren Sperren Sperren Sperren Patient visite visite Visite Fig 37 Visit plan in the form overview with the buttons for reviewing or freezing all the forms of one visit right part of the marking for reviewing or freezing a
69. ere are problems with the data which cannot be solved during the data entry but you still wish to continue with the data entry there is an option to disable the plausibility check This depends on the configuration in the FormBuilder You can do this by deactivating the checkbox Check data next to the Save button This can also be useful for longer forms when you need to postpone data entry but cannot save the form in its current state because a rule check prevents this Deactivating the plaus ibility check should be an exception and not the rule Incorrect forms e g letters in number fields still cannot be saved Error messages dealt with in this way will be displayed with a red exclamation mark next to the form icon Summary steps for entering data into forms Click on the icon of the form you wish to work on in the form overview Enter the data into the corresponding fields If necessary enter comments and questions see Chapter Entering and viewing comments and queries Click on Save to save the entries or SAVE AND PRINT if you need a printed copy The data entry will be confirmed You now have the option to edit the subsequent form or return to the form overview Entering data into forms is performed using a range of different functions which depend on the type of question You will already be familiar with most of the elements from filling out forms on the inter net However in secuTrial there are a few combined fields which
70. events that occur when entering patient data These events can be integrated into the patient datasets and displayed in the form overview in a separate tab To access the entry page for adverse events click on the ADVERSE EVENTS tab in the form overview This is located above the symbols next to the visit plan tab Click on the link New ADVERSE EVENT On the entry page for adverse events please select whether it is an Adverse Event AE or a Seri ous Adverse Event SAB If no selection can be made an SAE can only be made after first filling out a form for an AE m On the input page for AE please enter the date of the event and the date of the follow up in the cor responding input fields Click on Save to continue or on CANCEL to return to the form overview The entry is omitted if the option to skip the interim page has been selected for the project In this case the data will be preset in the background with the current date and time a Please check the respective time zone lf you are entering data from a different time zone e g for international or multi centre studies it is advisable to use the time zone of the main study centre A form will then open where you can enter specific data regarding the AE Continue as usual with the input fields dropdown lists and radio buttons Click on Save to save the data Click on SAVE PRINT if you need a printed copy Click on CANCEL to return to the previous window without saving any of the
71. ey are included in the download list appended by the document s project version Mm Documents of project versions are displayed in the list with the name accordingly extended by the project version The documents are checked for changes and only if there are differences will they be included in the list If documents have not changed over the course of multiple project releases only one document will be displayed in each case the current project version or the last archive ver sion Form Data Mass Import s If a project uses the CPV feature the respective project version of the patient s centre is used for the validation of each data record The data record can only be imported if all information is correct for that version If not the data record is rejected with an appropriate error message For example if the form definition does not exist yet in an older project version the data cannot be imported for that ver sion E The productive project version is always used during the import analysis Discrepancies Import DTM a Similar to the mass form import the import module of the DTM checks which project version the imported discrepancy belongs to The validation is done with that version and the import is rejected if not appropriate Change to an Earlier Project Version Should the used project version of a centre be reset to an earlier version after data entry that could result in some complications if both versions differ in dat
72. f an additional window is opened in the form view e g to edit queries All reports are always opened in the same window The report view may vary depending on the information presented Patients are usually displayed separately according to centres and you will need to click on the desired centre to select it If there is no option to sort manually the patients are sorted alphabetically according to pseudonym Note Note When using the function Patient in multiple centres it can also be specified for visits that they can only be viewed and edited from the creating centre This editing and viewing limitation regarding the form data for centre specific visits does not apply to reports Depending on the report definition par ticipant may be able to view data that they would otherwise not be permitted to display or edit How ever it is not possible to access forms which cannot be edited via these reports e g displaying queries and an error message will be displayed accordingly therefore the use of reports if using centre specific visits should be considered carefully For all report types that list patients per centre the number of patients in the centre is listed in brack ets after the centre name Each patient is only listed once in these centre oriented reports even if the patient is assigned to multiple centres function patient in multiple centres activated in the FormBuilder If you and the patient have only one mutual
73. f the entire action is displayed as the number of successfully processed forms OK and forms which could not be edited No distinction is made between previously saved forms and unsaved forms The details right down to the individual form can be viewed by cascading the results list The final results list can also be downloaded as an Excel file Revalidation By conducting a revalidation the results are even more precisely differentiated OK OK with rule violations No action Invalid preconditions Error OK with rule violations lf error or warning messages occur during a revalidation the form will still be saved and given the status with errors or with warnings In this case the mass action behaves as if you has deselected the Check data checkbox in the individual form No action lf the revalidation did not result in any changes see above section on revalidation the revalidation will likewise not be saved in the mass action Invalid preconditions As the revalidation of a form can have an effect on other forms via rules e g changed form preconditions frozen forms before performing a revalidation the form preconditions for each individual form are checked again If these are not fulfilled or no longer fulfilled the form will not be edited any further and marked as such Error lf any other problem occurred during the revalidation the result will be displayed as error Fig 16 Examp
74. fined for the project when creating a new patient the centre prefix will automatically be placed in front of the Add ID as a non editable component New patients can only be created if the prefix has been set in the AdminTool otherwise an error message will appear when selecting a centre When entering an Add ID any invalid formats will be reported in an error message Enter the entry date for the patient Depending on the configuration the date field is optionally preset with the current date or the date must be entered Click on CONTINUE The patient entry form will then appear If you want to enter data for a patient who has not yet been added to the system you will be directed to a page for entering the patient s personal data provided a patient entry form has been created in the FormBuilder Important seculrial a Sect Pat ID xaq 41 Add ID fas Entry date 12 02 2008 CET Date of patient consent J J dd mmyyyy Personal data Gender C Female Male Last name First name Cancel Print and create patient Fig 19 Form for pseudonymisation of the identifying patient data Follow these steps when filling out the form To enter the name address etc use the respective input fields To enter the patient s gender click on the relevant button see above Mandatory fields are indicated by a red star A data record can only be generated if all of the mandatory fields have been filled out The informatio
75. for the words thorax lung would find the entry Lung and thorax diseases assuming this entry exists in the catalogue When searching for set terms that contain a space please use quotation marks for each word For example if a search is conducted for Lung ana the entry Lung and thorax illnesses would be found but not entries such as collapsed lung After a search all of the entries in the catalogue which contain the search term will be displayed in a list The found entries will be indicated in bold and the found terms will be highlighted in yellow To fully display the hierarchy superordinate items will also be shown if one of their sub items is con tained in the search results If they do not contain the search term they will not be shown in bold If matches only occur in one of the upper levels without matches in any of the lower levels these will be shown in bold and collapsed The catalogue column display can also be filtered in the search function Only the categories that have been selected with a tick will be displayed Filtering the display does not affect the search res ults It is thus possible that a term is contained in a column but because of the filter the column is not displayed In this case the actual search result will not be displayed but all other columns that are associated with the search result in the catalogue and which have not been deactivated by the filter will be displayed Click on the triangles t
76. he empty fields will be automatically filled out and the form will be displayed again for confirmation Only after confirmation by saving again will the form be saved Please note if you do not confirm by saving again the form will not be saved All entries that have been made and all changes will be discarded and lost No entry will be generated in the Audit Trail If only one level of a catalogue can be filled out in the form All fields have been fully and correctly filled out gt The form will be saved Not all fields have been fully and correctly filled out gt An error message will be displayed when saving the form and the values must be corrected 5 5 Repetition groups By integrating subforms in repetition groups it is possible to include several details for a single point An example would be listing all prescribed medication Medication Medication 1 preparation dose time of intake es ee enn No Fig 46 Repetition group with subform medication By clicking on the More button you can create a new group or if configured delete a group with the DELETE button Deleting a group can only be done if no queries or comments have been made The data from deleted repetition groups still remains visible in the Audit Trail 5 6 Uploading images To upload images click on the link button in the image component to open a pop up window for selecting a file After starting the upload process a progress bar and the
77. in clinical trials Welcome to secuTrial Kunde This area is non public and accessible for registered participants only If you are a registered user please enter your user ID and password in the respective fields When you enter for the first time you will be required to change your password At following logins you can change the password when manually using the Change password button User ID Password Login Change password Fig 1 DataCapture login page a To log in to DataCapture enter your user ID and password Your user ID has already been assigned to you together with your password s The login procedure involves three steps 1 Enter your user ID exactly as it was assigned to you Make sure to use exactly the same capital and lower case letters 2 Enter your assigned password 3 Click on Login 2 1 Logout S e C ulrial in clinical trials Wilkommen bei secuTrial Kunde You have successful logged out To login Fig 2 Information page after logging out Each time you have finished your work and when leaving your work station you must manually log out Locour in the top menu bar to ensure that no unauthorised persons can use your user account After logging out an information page will be displayed Use the provided link to return to the Login page lt may happen that you will be logged out automatically if the server does not register any activity server contact for a longer period
78. isit 29 03 2013 CET BA Form Source data verified F Signature By entering your user ID and password you are confirming that you Source data verified User IO Password Cancel Sign save Fig 60 Selection for SDV patient with affected forms listed Underneath the dropdown list is an overview table of all the forms which fulfil the requirements for performing an SDV When performing an SDV for a visit SDV visit only the forms for that particular visit will be included If the SDV is conducted for the whole patient SDV patient all saved forms of the patient will be listed in the table and be sorted according to the respective visits Click on Save to adopt the changes Click on CANCEL to return to the form overview without saving any of the changes Automatically resetting the verified status After the SDV status for an item has been set to verified it may for some reason occur that the value of this item is changed at a later point in time for example due to the creation of a query When saving the modified form the SDV status of the item will in this case be reset to not done and the form status will be recalculated The project can be configured for email notification to be sent in the case of this unlikely event The data must then be checked again 6 7 Data Entry Complete DEC If the DEC function has been configured for the project and you have the necessary writing rights
79. isit in visit plans in which no form dates have been saved can be deleted with a reason The last unplanned visit of the defined visit type can also be deleted if no form data has been saved saved there yet 4 5 Status and Help a The status of the forms empty partially filled or completely filled is displayed with different coloured symbols Click on the HELP button on the form overview page of a patient to open the Help Form overview window Here you can read the explanations for each of the symbols Print Close Help Form overview without db table These forms will not be stored in the database not stored Mo data has been entered yet A empty The form has been saved empty In the form family at least one form has been stored empty partially filled At least some data has been entered but not all mandatory fields have been filled Mi completely filled All mandatory fields have been filled E data entry complete The data entry is finished This status does not display the underlying completion status SoD aaa standard form Used for the capture of normal data B Adverse Event form For capturing data during the workflow of Adverse Events A serous Adverse Event form For capturing data during the handling of Serious Adverse Events Fig 36 Help window with explanations of the form icons partial view 4 6 Project selection If you want to switch between the different part projects sub projects of a particular patient
80. le of a revalidation results page PN 14 10 2010 15 52 CEST DVMD secu Fla Pr Dr Jonas neu PROH New patient You can either create a new patient or take an existing patient over into a partproject select a project DVMD Select a centre neu PROH Additional patient ID Add ID Create Visit plan Please enter date of entry first visit as the base for the visit plan Entry date H H dd mm yyyy CETICEST Cancel Continue Fig 17 Creating a new patient an Add ID is only necessary if the project has been configured this way 4 1 Adding a new patient to the database For projects it can be defined whether patients can participate in only one centre of this project or whether they can be entered into multiple centres With patients in multiple centres new patients are created in a centre as normal This is stored as the home centre in the casenode entry These patients can then be subsequently assigned to other centres Depending on the role rights of the centre participant the patient can be viewed and edited in all of his or her centres see Patient in multiple centres Patient in single centre One way to add a new patient to the database is from the Welcome page after logging in Every patient whose personal data is entered into the application is given a pseudonym for identific ation Pat ID Depending on the chosen configuration there are also two additional patient ID pseudonyms th
81. ll of a patient s forms left part of the marking 4 8 Patient access optional If patient self documentation has been configured for the project you can set up a patient login at any time After you have created the patient in the system the PATIENT LOGIN button will appear in the top right of the form overview Click on this button to set up the login If you have selected a patient for whom a login has not yet been created you must first assign a role for this patient and then click on Save Without an assigned role the patient will be unable to view or edit his or her data 14 10 2010 13 21 CEST Greifswald DYMD a a Pr Dr Jonas aaa009 Secu Fla DYMD 14 10 2010 13 14 31 CEST Patient Login Edit Visit plan Patientfile New patient Select Edit patient login Here you cann assign a role to the current patient which allows the patient to enter data on its own into the system Also the patient s access to the system itself is configured here Role of patient aaaQ09 in centre Greifswald D WMD of project DYMD lt no role gt Save Back Fig 38 Setting up a login for patient self documentation z The next step is to click on SETUP access Two links will then appear that both create an email to the patient from your standard email programme either Outlook or another email client The patient will need both emails to set up the login a The first email contains a link to DataCapture with th
82. logue Comment Name er o Model label Delete Nore Dipl Biol Susanne Schneider Re i Daten eingegeben 15 04 2014 16 09 04 CEST sion 15 04 2014 15 58 06 MESZ Cancel Save Save close entry M Check data Date 03 06 2014 CEST Clinical Investigator Dipl Biol Susanne Schneider Project Example study 03 06 2014 18 59 10 CEST Centre Berlin Pat ID epm318 2 visit 30 03 2014 CEST Form family MIV Form Mw Test Document No 66 8 Fig 29 MV editing window after clicking on the MV icon next to the first radiobutton MV and rule evaluation Depending on the defined rules and rule conditions it may not be necessary for a value to be entered not required for the completion status or entering a value may not be permitted input impossible In this case when evaluating the rule the MV status will automatically be set to Value not collected due to rule This status is indicated by a grey MV icon It cannot be actively selected by you MV Test Document o 66 10 Please correct the marked invalid data 1 Some simple entries aj Radiobutton v OC yes no Enter value or mark with different reason as missing value b Shorttext ol Sor 10 Other entries Enter value or mark as missing value a Radiobutton ZO Cia nein Enter value or mark as missing value b Another input field Da O Fig 30 Error messages for the MV function because of the Input impossible if r
83. losed a Review B cannot be performed Clicking on the Review button locks the saved data and prevents further editing by participants with writing rights i e Clinical Investigator It is still possible to write and revoke reviews and to edit com ments or queries Editing the actual medical data however is not possible for the time being After a review has been completed the form icon in the form overview will be displayed with a trian gular flag beside it a flag at the bottom once a Review A has been performed a flag at the top once a Review B has been performed If a form has undergone a Review B and a query is then created by a participant the form will be locked and will lose its Review B status The form can only be closed with a Review B once the query has been answered see chapter 6 2 When using DEC within a project see chapter 6 7 the form review function is only available after the data entry has been completed Any data changes made in the form will not be saved when per forming a review 6 6 Source Data Verification SDV Source Data Verification SDV is an additional process which can be configured for a project to ensure data quality It enables comparisons between the study data and the original data to be recorded in the secuTrial application Verification is possible for every item however summary checks or random spot checks are also possible for forms visits and all patients After data entry has been
84. n in the date field will be checked for the correct format Once you have filled out all of the mandatory fields click on PRINT AND CREATE PATIENT A new window will appear with a print preview of the patient s personal data and the pseudonym assigned to the patient The pseudonym and the patient s visit plan will be saved in the database The print preview contains a separate text field for listing personal data and status information sep arated by a semicolon The data can be copied and pasted into another programme e g Excel You therefore have the possibility to create your own re identification database Please make sure that the data is not been saved on a computer with an internet connection and that your database complies with local data protection regulations and security guidelines for data management A print message will automatically appear and you will need to press print to complete the printing process Keep the printouts containing the patient pseudonyms and personal data in a safe place You will need the pseudonyms to edit and update patient datasets Before you close the window to continue check to see if printing has been successfully completed Warning all patient identification data will be deleted after you close the print window You will receive a message confirming that the visit plan has been successfully created Click on CONTINUE to go to the overview page for the individual data forms referred to as the Form Ove
85. nas 21 05 2010 11 51 47 CEST Pr Dr Jonas 21 05 2010 11 43 14 CEST Fig 62 Example of an Audit Trail As entering and saving comments queries and query answers as well as conducting an SDV per forming reviews form locking actions and data entry completion are all procedures that save the respective form all of these actions are recorded and shown in the save history in the upper section of the Audit Trail With each save procedure the current project version is also saved enabling changes to the project setup also to be tracked In addition you will be able to see whether an e sig nature was used when saving and whether this is still valid Note When changing data after setting a DEC Data Entry Complete a reason must be entered when saving This will be shown in the document history of the Audit Trail In the lower section of the Audit Trail you can see which entries were made when and who saved them If changes were made in the form the original entries will be kept in the Audit Trail Hidden questions or items will be framed with a dotted line If configured in the FormBuilder the column names of the items will be additionally displayed in the AuditTrail These are listed on the right hand edge in grey colour of the status display in a slightly smaller font If a user enters or changes data without saving it this will not be documented in the Audit Trail Click on Close to return to the form or on PRINT to print
86. nd able to comply O yes Ono with all procedures of the trial Exclusion Ca a Known allergies O yes Ono Query 6 Known or suspected hypersensitivity yes no to investigational drug de Heavy smoking gt 20 cigarettes per yes no day 8 Pregnancy or lactation O yes Ono l Patients participating in another O yes Ono clinical trial at the same time or durina the last 4 Please note that during a review possible data entries or changes will not be saved Date 25 03 2013 CET Clinical Investigator PM Project Standard 28 03 2013 11 50 27 CET Centre XP Pat ID paxB55 Add ID xp18 Screening 15 03 2013 CET Form family Ein und Ausschlusskriterien Form Inclusion Exclusion Fig 43 Example of a form n Once you have filled out a form please make sure you click on SAVE or SIGN SAVE to send the data to the secuTrial database otherwise the data won t be saved and may be lost If you are working on large forms it is advisable to regularly save the data to avoid losing data due to timeouts After you have entered the data correctly and saved the form you will receive confirmation accordingly for information on using individual input fields see Chapter 5 i Displayed at the bottom of the form are the author date reason and validity of the signature the last time the form was saved both in the online view and on the printout E On the confirmation page you can usually select whether you wish to go to the ne
87. ned centres In contrast the login status is only managed once per patient In this case just like a participant after logging in the patient must select the centre for editing z When editing patient access in DataCapture only the role for the current centre can be assigned In the AdminTool the patient roles can be edited simultaneously for all centres of the patient 4 9 Patient letter optional a To print out certain pre defined data from a visit in a patient letter click on PRINT LETTER This func tion is optional and is not available for all projects n To use this function you must have the explicit reading rights for at least one form of this visit 4 10 Patient file Patient files are an extended form of documentation in which all of the forms of one or more patients can be downloaded as an HTML file and then printed out The difference compared to the normal printing function lies in the data configuration options Whereas the print function always prints exactly one form the patient file function can be used for example to download all forms of all of the patients in a centre for printing Close Patient file Choose a patient Single patient All patients from ygobs0 ROD Ready Choose a visit a all visits O visit Choose a form all forms Form Queries and comments Show Audit Trail Showy LJ display DDE duplicates Original image files C Include Division per patient 1 file per patient O 1 file pe
88. ned in the FormBuilder If this is larger than the original the image not be enlarged The scaled image will maintain the size ratio of the original image For dis playing the image in reports and the Audit Trail an additional thumbnail max 75x75 pixel will be created The thumbnail will also be used for the form overview display of the image tab providing an image component has been selected as a thumbnail in the form All images are saved on the server in a directory specified in the configuration file For organisational purposes the files are arranged in several sub folders that are created according to the reference numbers of the internal patient ID database Images can be downloaded from the display window or by clicking on the original file name Down loading will begin in your browser and the file will be opened with the application specified in your browser for this file type Downloading is also possible from the Audit Trail 5 7 Uploading DICOM images Apart from image files you also have the option to upload DICOM images or a series of images Uploading is started with a separate link in the pop up window In the applet window that opens DICOM images can be selected from the file system or the user s CD drive You can select indi vidual images a series of images or studies of a particular patient A new DICOMDIR file will be cre ated which only contains the uploaded images The DICOM applet is implemented in Java You may h
89. ntral access point for the various functions of the application Depending on your assigned role on this page you can Create new patients Access patient data Access reports and statistics View and write messages Access and change your own participant data My Account Import form data or discrepancies Perform a qualification test Download documents 5 The Welcome page contains general information about using the application B Use the HELP button to obtain detailed descriptions of the various functions Click on the WeLcome button to return to the welcome page from any page in DataCapture The functions My AccounT IMPORT DOWNLOAD New PATIENT REPORT AND QUALIFICATION TEST are only available if the project has been configured accordingly 3 1 Qualification test optional For certain studies you will first need to prove adequate qualification before you are permitted to cre ate new patients and edit data In such cases instead of showing the above listed functions when you log in to DataCapture for the first time the Welcome page will offer you the option of performing a qualification test e The Test button button text may vary according to configuration in the header displays the test overview After the test has been successfully completed you will automatically receive access to the database and be able to enter medical data into the study 3 2 Please click on the Test button to displ
90. o open the entries below All sub items of the open chapter which were included in the search will continue to be highlighted Click on the triangle a second time and the chapter will close However the highlighted sub items with the search results will continue to be displayed To see all chapters again and return to the normal catalogue view click on RESET to end the search You can transfer catalogue entries directly into the input fields of the main form Simply click on the entry it makes no difference whether you do this following a search or by browsing The catalogue search window will close and the values will appear in the corresponding fields of the main form Please note that when you select a catalogue entry all associated entries of this and all superordin ate levels if existing will be transferred into the form Important The entries from the subordinate levels will not be automatically transferred If you wish to transfer the complete data of a catalogue entry you need to select the entry at the lowest hierarchy level by clicking on it Note If you select an entry in one of the top levels in the catalogue for which no input fields exist in the form the catalogue window will close after you click on this entry without transferring the values Exception Entries exist on one of the superordinate levels and corresponding input fields exist in the form In this case all of the superordinate values for which there is an
91. oad server contact and at last during the finally rule evaluation before form save The conditions will be updated if necessary during this occasions Rule evaluation during form save Hidden items are ignored during the final rule evaluation before form save and treated as non exist ent Possibly previous entered values are maintained during form display but will be set to NULL during form save If the values has been stored already they will be moved to the audit trail All rules defined on hidden items will not be evaluated possible defined actions not performed regardless if the action would be triggered by a NULL value Form display The display of the form will be adjusted according the matching Hide rules during form editing form print and in the patient file The audit trail in contrast always displays every defined form item inde pendent of display in the entry mode Queries and comments Once a query or comment has been made on an item the item or enclosing question cannot be hid den and possible matching Hide rules are ignored The form element will still be displayed even if a Hide rule will evaluate to true after a value change Vice versa it is possible to create a query or comment for a hidden item and by that force a display of this element It is although not possible to create a query or comment for a hidden question because the menu option is not visible by hiding of the complete question section in the form
92. offer additional functions In the event of a format error or plausibility error you will be informed accordingly with a message which will appear directly above the respective entry field Instructions will also be provided to assist you with entering the data 5 1 Basic form components In text fields you can enter any text you wish The length of the text is restricted to the length of the field displayed Comment Number or date fields restrict the entries to numbers only or to valid dates and times Some date fields must be completely filled out while in others you can leave out some information e g the day from a day month year entry The required format is shown to the right of the data input field Date of birth YT yi del mm y yy Decimal places are displayed in the second numeric field Body weight kg 6 A radio button is used for either or questions and only one answer is possible By double clicking the chosen option you can deselect the radio button Sex ae e female With resettable radio buttons you can undo an entry by choosing NOT APPLICABLE By double clicking the chosen option not applicable will be selected again Sex f not applicable male female A checkbox is used for yes or no questions To agree with a question activate the checkbox with a mouse click A second click removes the tick from the checkbox Blood sample taken With the dropdown lists you can select one out of a list of sever
93. onducted for the respective home centre If you are not assigned to this centre or don t have the necessary rights the import cannot be conducted for these patients Centre specific visits are also checked during mass imports In this case the centre selected for import see above will be used If the selected centre and the centre for the centre specific visit are not the same the import cannot be carried out Mass import for multiple forms When importing into multiple forms the preselection of visits and forms is skipped and only a suitable import configuration and the file to be imported has to be selected 1 Click on IMPORT in the main menu top right of the Welcome page and select Form data for multiple forms 2 Select the relevant project 3 After selecting and uploading the file a data preview will be displayed and at this point it is still possible to change the file format details separator encloser start line of import Next the file analysis will be performed and the participant can then decide whether datasets should be imported with warnings Only then will the actual import be conducted 4 In the Audit Trail the imported data will be marked as Data imported after saving In the import file the data for the different forms must be prefixed with the identifier for the respective form import format as identifier externalkey 7 j 03 06 2014 20 03 CEST secu Fla Dipl Biol Susanne schneider hy Ac
94. ool and FormBuilder If you have the necessary authorisation for the DTM you can use the DTM via the IMPORT button on the Welcome page In the dropdown menu next to IMPORT oF select Discrepancies Importing discrepancies ial 14 10 2010 15 44 CEST secu Fla Pr Dr Jonas MyAccount Messages Import Reports New patient Select Import discrepancies Import of Discrepancies Please select the project for which you want to import the discrepancies You can edit the discrepancies afterwards from the menu item Reports Project DYMD Include the discrepancy text in the search for doublets Select the file for upload o Durchsuchen 1S0 8859 15 Upload The upload can take a period of time depending on filesize and connection Fig 10 Importing discrepancies The files that you wish to import must either be in XML or CSV format Further details and extracts from example files can be found in the Appendix The project must first be selected from the options list for the discrepancies that are to be imported This lists all projects that you have been directly or indirectly assigned to by association with a centre If only one project is available this project will be automatically selected and no list of pro jects will be displayed To prevent the same data from being imported more than once a doublet search will be conducted during the import process and any doublets will be discarded The double
95. or creating a new patient ooocccccccncocccccnncnncnncncnnncnnonncanonnnnnrnnnnnnnonanons 24 Patient I MUM DIG Conte evacrisa iii 25 4 2 Entering and editing datasets form OVervieW oocccconnncconcnncnonnconocnnnnnnncnnnnnonnncnnonnnnnnnnnnnnncnnnns 25 Entering and editing with patient in multiple Centres cooccconcccocccoconnnncnnoncnnnnnnnnncnnnanonnns 26 Entering and editing with double data entry DDE occcooccnnoccncconccnncccnconocononanononnnnnnncnnnnos 27 Participants for data entry 1 and B oooooocnccoccnccnccnnnnccnnnnonnnnnnnnonnnnnonnnnnonnnnnonncnnonnnnnonarnnnnnrnnnannnrs 28 Participant conducting the COMPATISON occcocccocncocncocnconnnnnnonanonnnonnrnnnnnnnnnnnnnonnnonnnonanonarinnnnnns 28 Basie ParUCIDAN sce AAA sees eee ceca Pueo o A 28 PPP 28 Status display DDE coincidir 30 Data entry and executing at configurable randomizati0ON ooccccccnccccncconcconnnononccnnnnoncncnnns 31 Rano AMO e secar tine no tte tiendas 31 PIRAN ee E alte ntact raged E E T tecemettss 31 o o o ZP A 31 Data entry and executing with hidden items oocccocccconcccocccnncnconcnconcnnoncnnnncnnnronnoncnnnnnanos 31 Rule evaluation during form SAV6 cccooncnccncnccccononcnconononnnononononannnnnnnnnnnnnnnnnnnnnnnnnnnnonnnnnnenanenns 32 Ss o E A 32 TSS IC CO AM rr seeenaueesmaceqaceseentennuueateuces 32 Data entry and editing with missing values MV ccccccseceeseeeeeeeeeeeaeeeeea
96. or the project version of a single centre then only this centre will left out from the report If the visits have not been created chronologically with a different number of repeated visit groups or in the case of a modified visit plan template when displaying the individual patients there may be empty spaces or skipped information Displaying a report sorted by visit type can take considerably longer than a chronologically sorted report visit sorting can be configured in the report definition In a chronologically sorted report the patients are not listed separately according to treatment arms In this case the patient visits which are displayed one below the other may not be of the same type For this reason the headings are displayed only with simple numbering Additionally indicated in the title of image reports is the number of displayed forms compared to the total number of displayable image forms display can be filtered via selection lists With SQL reports the number of rows is listed in the same way If the number of displayed rows per page has been set for the SQL report in FormBuilder page but tons with the page number are displayed in the title row at the top right of the screen These can be used to click through the different pages If the filtering or sorting has been altered the display will always jump back to the first page of the currently displayed lines After viewing click on the PRINT button to print the report and
97. orm the import If so then click on IMPORT If not click on CANCEL 7 All of the data that has been analysed as error free will be transferred into the form but it will not be automatically saved After the data has been successfully imported it will be displayed in the form It is not possible to edit the data directly after importing 8 To transfer the data to the database click on SAVE 9 After the imported data has been saved it will be marked as Data imported in the Audit Trail 6 2 Entering and viewing comments and queries The buttons to the right of the individual questions in the form activate these questions or the special functions assigned to question groups Use the COMMENT and Query buttons to enter comments and queries if your role permits this function By hiding certain items or questions you may find that queries can no longer be edited This also prevents open queries from being closed In the displayed form icons this has no effect because the open query is not included when calculating the form icon New queries and comments cannot be added to questions that have been hidden Important Comments Frint Close Comment Document Ho 153 1 What was made F How much Please enter your comment Cancel Sign save Fig 53 Field for entering comments In this example the comment entry must be signed Comments may contain remarks or instructions for yourself or other participants
98. place simultaneously If a DDE form is open it is locked against any further editing even in another dataset As a participant for DDE data entry you can only see and edit your dataset if the first data entry has not yet been completed Data entry can only be reopened if the comparison has not yet been com pleted Once it has been completed the following message will appear The form is no longer edit able the double data entry is already completed Participant conducting the comparison As the participant conducting the comparison with both DDE rights when opening form family you will be able to see and view both datasets displayed beside each other in the overview However you will not be able to create or edit them until the first data entry has been completed The already entered data is displayed with the message The form is not editable yet the double data entry is not completed E The form is not editable yet the double data entry is not completed General Data DDE 4 Enter Data HRB O yes no Cancel Date 25 03 2015 CET Clinical Investigator Phi Project Systemtest 441 26 03 2013 12 50 11 CET Centre Ready Pat ID yaoi Add ID ROOT 1 Startvisite 28 03 2013 CET Form family Vvistte Form DDE Form Fig 24 Message that the form cannot be edited yet After the data entries have been completed as the comparison participant with both DDE rights you can correct the completed dataset Both the firs
99. processing status will appear in the pop up window The form will be hidden in the main window as no further procedures may be carried out while uploading If you close the pop up window or leave the form page the upload will be cancelled You can also cancel by clicking on cancel in the pop up window After can celling or after the upload has been completed close the pop up window and the form will be dis played again with the uploaded and scaled image Only after the form has been saved will the image be permanently referenced in the form otherwise it will be deleted from the server roen L l l l l Le Upload an image Fig 47 Form extract image item with a link to the upload pop up window Image upload Upload an image file Please choose a file to upload Or open the Dicom file chooser Dicom Browser Fig 48 Upload image selecting the file to be uploaded While uploading time consuming large files DataCapture can be used by other participants as nor mal When uploading a large number of files simultaneously performance may be slightly affected The participant who is uploading files cannot perform any other procedures until the upload process has been completed After uploading in addition to the original image two further images will be generated for display providing it is possible to scale the image file In order to be displayed in the form an image will be created in the maximum size defi
100. r form freezing is actually carried out If an e signature is entered the revalidation will be signed even if this has not been configured If there are no changes in the checked aspects the revalidation will not be saved and no follow up actions will be carried out On the interim page you will be notified whether the revalidation was per formed or not 6 9 Centre Specific Project Versioning CPV In the productive DataCapture the data entry does not change much at first sight by using the CPV function The project set up with which the patients are created and edited are determined by the project version of the patient s centre This affects all properties and functions of the project e g visit plans form set up extended function configuration SDV DDE etc Exceptions for this principle are described below Because there is only one right administration for all project versions and some functions cannot be applied to archived project versions there are some functions where the configuration of the pro ductive project must be checked instead of the used archived project The effect of the Centre Specific Project Versioning CPV on the following functions will be described below Status Header Data Entry Forms Visits Document History Audit Trail Reports and Statistics Download Documents Form Data Mass Import Discrepancies Import DTM Restrictions and Exceptions Status Header
101. r visit AE patient 7 Fig 39 Patient file printing window mark up button for barcode print The patient file can be found in the form overview under the correspondingly named button After clicking on the button the above pop up window will appear Here various options can be selected for patients visits and forms After clicking on the option Form depending on your user rights you can select individual forms to print as a patient file under Choose a form The Audit Trail can also be included in the patient file To do this activate the checkbox SHow next to Audit Trail At the end of the form an overview will then be included detailing the document his tory and document changes This is a thumbnail view of the Audit Trail window Activate the checkbox SHow next to Queries and comments to include these in the patient files The queries and comments will be listed in an overview at the bottom of the form The image forms will be included when printing the patient file if you select either all forms or a visit that has associated image forms The patient images will be included in a folder entitled patientimages in the zip file Image icons and other symbols will be saved in the folder img With the Original image files checkbox you can include the originals in the patient file You can then display them directly from the patient file or download them If you include the original images this may make the patient file ve
102. right of the questions for the comments and queries buttons Click on the HELP button to obtain information and instructions on the individual questions in a separate window If you are uncertain as to how a question should be answered check to see whether a help text is available to provide clarification The help texts can also be printed out by clicking on the PRINT button To close the help window click on the CANCEL button 6 4 Print There are two methods for printing a form Click on the PRINT button in the main menu at the top right of the page or use the Save PRINT function at the end of each individual form Please note that the PRINT button only appears if the form has been saved at least once The PRINT button in the main menu at the top right of the page prints the version of the form which was last saved A print preview is displayed in a separate window which you should then close after printing By pressing the SAVE PRINT button all data which has been added to the form or changed will be saved and then printed A print preview will be displayed which you should close after printing In the Audit Trail this action will be recorded as a save procedure 6 5 Review Regardless of the form completion status participants with a review rights will find a Review button marked Review A or Review B next to the CANCEL button at the bottom of every form Exception if the form contains a query that has not yet been c
103. rview If consecutive generation of Add IDs has been configured for the project when creating a new patient the time until you are automatically logged out if you do not have contact with the server is reduced to 5 minutes After ending the process the time until automatic logout will be set back to the standard number of minutes Summary steps for creating a new patient Click on the NEw PATIENT button on the Welcome page 2 Select the centre or the project to which the patient is to be assigned and create an Add ID if required Enter the entry date and click on CONTINUE 3 Enter the data for re identifying the patient 4 Fill out all mandatory fields 5 Click on the PRINT AND CREATE PATIENT button 6 Check if printing was successful before closing the window 7 Close the printout preview and click on CONTINUE Patient in multiple centres i If patient in multiple centres has been configured in FormBuilder you can select whether a com pletely new patient is to be created or whether an existing patient is to be included in the previously selected centre To do this you must enter the known pseudonym for this patient so that the patient can also be assigned to this centre E T 15 08 2013 17 37 CEST Example study 15 08 2013 17 37 53 CESTI secu Fla Dipl biol Susanne Schneider Berlin New patient You can either create a new patient ortake an existing patient over into a part project select a project
104. ry large the file size will be shown in the download link With many forms for each visit or many visits e g more than 10 the patient file should be divided per visit Otherwise it is possible that the patient file will be unable to be created When dividing up the patient file all adverse events and the casenode forms will be given a separate file for each visit The files are numbered consecutively for each patient To guarantee that the data is correctly displayed you can select different character sets for the patient file A character set suitable for your system should already be selected by default After you have made all the necessary settings you can export the patient file by clicking on GENERATE PRINT or close the pop up without saving changes by clicking on CLOSE or CANCEL You will then be given the results in a zip file for you to download The required forms are saved in a format ready for printing For each patient exactly one or with a breakdown multiple HMTL file s will be created in which all selected forms are consecutively listed In addition a PrintOptions file will be created in which your settings are saved The images that were used will be provided in an additional folder img If a patient is in multiple centres the patient files for a particular centre list all of the patients that are assigned to the centre This enables patients to be documented in multiple files and also applies to archiving project
105. s Furthermore centre specific visits are not displayed if the current centre does not correspond with the centre for the visit Barcode print for pseudonyms In addition to print the whole patients file you find in the window the function to print barcode labels for the patients main pseudonym see mark up Fig 39 Clicking the button PRINT BARCODES opens a new Selection popup window There are several stand ard label formats you can select from You can also choose to print the whole page or only single rows In addition to the barcode the pseudonym the patients name and the date of birth can be prin ted in plain text Print barcodes Layout Avery weckform 3666 dimm x 21 2mm 5x 13 Rows All from 1 to 13 Additional text Pst ip Fig 40 Configuration of the barcode print The barcodes will then be shown as a tabular page in the selection window This page has to be adjusted to the selected label format paper with the normal print menu Moet ete Wore Me ba on ew EC A A Mig Ot Sp Pie ar se HA Pac dues es ee eos Wig sc Se ie ue OE Nt tek ea Me eS Mem Fer OP a tg ie ee ee a ul I aku233 akuz33 i aku 33 F aku 33 i aku 33 aku233 akuzzs aku233 aku233 aku233 Fig 41 Section from the barcode print page with additional display of the patient s pseudonym in plain text 4 11 Adverse events secuTrial has a special work flow for documenting adverse
106. s well as the import format and visit into which you wish to import If you have defined a form field as a dataset identifier for mass imports you do not need to select a visit You also do not need to select a visit if an import format with visit specifications has been created in FormBuilder and the visit must be entered in the import file 5 Select the file you want upload by clicking on Browse 6 Click on Upload to start the import process In the same window you will now see a preview of the measurement data to be imported and can change the column separator and column delim iter if necessary 7 Click on Analyse to analyse the datasets and display the result The analysis shows the num ber of successfully analysed datasets and the number of datasets with warnings It also shows the number of datasets which were unable to be assigned and or were ignored due to variable errors or format errors Errors mean datasets that were unable to be attributed for example because the pseudonyms are missing Warnings are datasets in which individual columns are unable to be assigned They may be in the wrong format for example You have the option of importing these datasets However the missing columns will not be included in the import 8 On the basis of the error overview you can decide whether you want to perform the import or not If you do click on Import If you do not click on Cancel 9 All error free analysed data and if selected th
107. st also be allowed You can disable ActiveX if you wish If you don t want to use DICOM pictures you may deactivate Java For security and data protection reasons the cache should be set to zero If your browser has a pop up blocking facility this must be disabled Should you require support with the browser settings please contact your local system administrator 1 2 General user information DataCapture is accessed via the internet If your internet connection is slow unsafe or unstable this will inevitably limit the performance of the system The URL internet address for logging in to DataCapture has been provided to you separately along with your login details user ID password Depending on which browser you are using there may be slight differences in window views or in the menu and print layout All DataCapture functions have been tested with standard browsers NEVER use the browser functions Refresh Back or Forward Please use only the secuTrial buttons Clicking on the CANCEL button takes you back to the previous page Clicking on the CLose button closes the current window and takes you back to the main win dow Click on the Locour button to quit the application If you want to log in again you will need to re enter your user ID and password The secuTrial menu buttons are always located at the top right of the page If the warning before data loss is configured this is displayed every tim
108. st be entered or MV must be set to Value not collected This error message will be treated as a hard error message Saving the form is then only possible by unchecking the Check data checkbox The error message will also be listed in the validation report If configured in the project all items with the MV status set to Value not collected will be con sidered as complete for the purposes of determining the completion status The MV function can therefore be used instead of a Ignore for completion status if rule Unlike the evaluation of com pletion status rules the MV function only requires an action by the user in order to mark a missing value 5 x DataCapture lt dev version gt SDY 145 Mozilla Firefox 03 06 2014 19 00 CEST igator Dipl Biol Susanne Schneider http sus2 cai bin WebObjects DataCapture woa 7777 wo MWGFb9W6SS9MISIqvWb31g_01 Example study 03 06 2014 18 59 10 C secu rial Berlin Missing Value iS a gt tepm3 Wi cTest a Radiobutton C Y Value exists C Value not collected MV Test Document No 66 8 1 Some simple entries a Radiobutton SO yes Y Value not collected due to rule C no Other reason for missing value Yor 10 Other entries a Radiobutton YO Cja nein b Another input field ver 2er Cancel Set 2 Repetition Group Subform 1 Sub form score Number oT Test check box in sub form on Popup vieleicht gt Catalog Sub cata
109. t and the second dataset can be changed once the respective data entry has been completed In the Audit Trail this is logged as DDE entry corrected see section Comparison Basic participant As a basic participant without DDE rights you cannot edit a DDE form if a participant for DDE entry has entered data and the DDE comparison has not yet been completed You can open the form but instead of values you will see the message The form is not editable yet the double data entry is not completed In the form overview this will be indicated by 1 2 next to the form If the DDE form has not been saved by either of the two persons entering data as a participant you can edit and save the DDE form as normal In this case double data entry is skipped and the two persons entering data no longer have the possibility to enter data Comparison During the comparison you can individually view and change the two datasets for the double data entry To identify differences there is a new button in the form overview of individual patients and in the report overview DDE comparison This opens a pop up window in which both datasets of all DDE forms can be compared with each other When conducting the comparison the data from the various centres can be hidden or displayed in the report overview When comparing a patient all of the data is immediately displayed lf a comparison is not yet or no longer necessary a message will be displayed accordingly
110. t search checks the follow ing properties of a discrepancy Table name Column name Patient ID Document ID Test No identification of the test programme Discrepancy text optional component of the doublet search depending on whether the checkbox has been ticked on the Import page Click on UPLOAD to perform the import for the selected file A preview of the file will then be dis played 1410 2010 7508 WCET J Pi Dr Jorge seculfFla MD CId 102010 15 10 07 CESTA e Ar con Massa jas mpar Reporta Pdea Pai Saladi Import discrepancies Prewlew OThM_20100210 cs0 4 arsangabe unklar Angabe peiifari mapprohanamnese bodyewcioh 466 1266 torsangabe unklar Angabe pedfen 1 rmapprohaniamiesa bodrheight JED 1266 WMtersangabe unklar l Angabe peufen min rohanammesalethic arsangabe unka Angabe peiifari 202 O3 2007 mnpprohanamnese testifield 486 1266 Aktorsangabe unklar Angabe pedfen Start analysis in line E fixed column sequence without column headers 2 Colin separator coma i sernicolor i abulator t C Others Column delimiter C quotalion marks i aposirophe 0 none Others Upplag fhe ager Anehee Cancal Redesh prensa Fig 11 Preview of the import file You can define the column separator and column delimiter as well as specify in which line the ana lysis should begin The import contents will be displayed in the preview according to yo
111. the type of information to be entered It is not always necessary for a form to be immediately completed Partial information may also be entered and then saved Mandatory input fields are indicated with an asterisk or with text when sav ing If the project has been configured accordingly open queries can be automatically answered by changing the value of the query item If you are required to give a reason for the value change hav ing successfully completed the data entry the reason will be used as the answer text for the query For automatic query answering you must have the right to both modify data and to answer queries see Automatic query answering in chapter 6 2 If the form has already been opened by another participant the form will be locked against further data entries In this case you will be notified accordingly The forms of a closed project can be viewed but not edited Forms in inactive projects can no longer be opened Plausibility checks Various data checking functions are integrated into secuTrial DataCapture to minimise the probabil ity of incorrect data entries and thus to improve data quality These functions inform you of poten tially incorrect data when you save a form As a rule checks are conducted on date formats e g you cannot enter 30 February as a date logical plausibility e g pregnancy only occurs in female patients and threshold values e g a pulse over 250 is highly unlikely If th
112. tient variable Pat ID pid Add ID Lab ID 0 by form field External variable Internal variable Comment demograpjhics Comment lt textifield gt y Delete New data record identifier Number format german number format decimal sign Text comparisons case insensitive for variables case insensitive for option labels Mass import Allow mass import needs at least one CSV Parser Parser Default Parser 000 Listing Parser x Assign operator Eoo e Text delimiter New parser Mapping entries 2 No External variable Internal variable Date format Import unit Option mapping Delete External option Internal option Moo DateofBirth demograpjhics Date of birth lt dateofbirth gt y dd MMyyyy xy Delete j Gener i tst sS demograpjhics Sex lt sex gt y male male i y Delete Delete female female 2 y Delete New option mapping D New mapping entry Fig 64 Example definition of the import format from the FormBuilder Example mass import CSV file pid Name Allergies Examination eea000 Schmid cat 120520081156 aaa0Q7 70 Muller dog 150820020850 Import in repetition groups Imports in repetition groups are possible by columns or rows
113. try DDE If double data entry has been set for a form the data entry views and processes are different With double data entry for every DDE form two separate datasets are initially created DDE 1 and DDE 2 During double data entry these are indicated in the form title in front of the document ID Concomitant Diagnosis DDE 1 Dokument Nr 303 1 Volunteers Initials l screening Number a Randomization Number a No concomitant diagnosis 20 Please note all relevant prior or concomitant illnesses surgeries and allergies Concomitant diagnosis 1 Diagnosis Surgery Start Fig 23 Specification of the DDE dataset in the form display The two datasets are then compared and merged into a single dataset Depending on the selected DDE rights there are three different role types for DDE entry parti cipants for data entry 1 and 2 each with a DDE right the participant conducting the comparison with both DDE rights and basic participant without DDE rights Participants for data entry 1 and 2 As one of the two participants for data entry with a DDE right you can enter your dataset into a DDE form independently from the other participant for DDE data entry You can edit and save the DDE form as many times as you like until you explicitly end the data entry process Editing is recorded in the Audit Trail with DDE entry or DDE entry complete Re opening is recorded as DDE entry reopened Data entry cannot take
114. uke 56 OA A A 56 6 2 Entering and viewing comments and QUETIeS cooccccoccccccnccncnconcncnncnnnnnnonanconcncnncnnonnnarnnronnnnnenens 56 COmMent still roce nacida cido edad teed dd 57 QUO Suda ooo ooo eid 57 Automatic query aNSWENNg seia a aa a a a naa 58 6 3 Question based help Unctionis nrn a a a E 59 OASEN e r r E A toos 59 ORO ROVIO e A e eee eee eee ete ee eee ae 59 6 6 Source Data Verification SDV kesri anapa a 60 Changing the SDV status at the form level ococcocccccconnconccnononnnonnonononononacnnnnaronaronanons 60 Performing an SDV at the form Overview level oocccooccccoccnccoccnncnonnconcnnonannonrnnnconnnnnnons 61 Automatically resetting the Verified Status ooonccccnncncconccnnoconononononaconnnncnonnnnnnonnnnnnrnnanonoos 62 67 Data Entry Complete DECI ii areas is ade a 63 REPETIDO Seatetces 63 60 6 IREVANGAUON ease a a 64 6 9 Centre Specific Project Versioning CPV c ccccccssscccseeeecsseecceeeecseneesseueceueceeecsecaeseeeseeeaeesas 65 Status He ade is 65 Data Enty FORMS VISIS Las E E 65 Document History Audit Talsarn alii io a A A 66 Reports and olas it e E S 66 Download Documents coa 66 FO Wala Masip talas 67 Discrepanci s IMpor DTM isos 67 Change to an Earlier Project Version ccccccccssscccssseeceeeeecessccceueescuseecseueceeceeesaeseeeseeesensas 67 O TOA TA al dad sareumeiees E E ee tee ee Genie 67 6 11 Electronte signature optional ci an 69 A A
115. ule the checkbox is automatically set to Value not collected due to rule Below no value is entered for the radiobutton or for the text field In the upper text field at first entry was not possible due to a rule condition MV status Value not collected due to rule then the value of the rule condition was changed Now the participant either has to change the MV value or enter a value into the text field The checking and any necessary setting of the MV status is always performed together with the rule check e also when performing a revalidation Changes in the MV error message are treated in exactly the same way as changes in rule error messages In this case the revalidation will then also be saved MV History The history of MV status editing can be viewed via a new button in the top menu bar labelled MV History Here all changes to the MV status are listed for the individual questions as displayed in the SDV history Date 03 06 2014 19 07 CEST Patient PatlD epm318 Rand Gr A Chie Clinical Investigator Dipl Biol Susanne Schneider 2 Visit 30 03 2014 CEST l Project Example study 03 06 2014 19 04 57 CEST Form family bay Frint Centre Berlin Form hi Test MV History MV Test Document Mo 66 Dipl Biol Susanne Schneider 1 Some simple entries 03 06 2014 19 06 03 CEST b Short text 6 value not collected due to rule 10 Other entries Dipl Biol Susanne Schneider 1 Some simple entries 03 06 2074 19 03
116. upload e To preview the uploaded images image series click on the DICOM icon beside the image to open a DICOM viewer applet The downloaded DICOM image or image series can otherwise be viewed and analysed with a local DICOM viewer Date 14 10 2010 16 12 CEST Patient PatlD aaa009 Add iD lt nicht Clinical Pr Dr Jonas B gesetzt Investigator Images Imageform Project DVMD 14 10 2010 14 10 2010 Pr Dr Jonas J 15 51 51 CEST CEST Zur ck Hilfe 5 a C U r a Centre Greifswald DVMD Abmelden 7 Wilkommen gt Patient aaa009 gt Imageform Queries Comments Audit Trail Print Imageform Dokument Nr 484 1 Gro es Bild seculrial 4 Comment secutrial_logo_small png 2 0 kB 150x40 Kleines Bild Datel andem CHAT Dicom_lmages 0f aaa009 zip 10 5 MB Last signed by Pr Dr Jonas Validity Signature valid at 14 10 2010 13 27 44 CEST Signature meaning Data edited Project version 14 10 2010 13 25 08 CEST Cancel Sign save Sign save close entry Check data Datum 14 10 2010 CEST Clinical Investigator Pr Dr Jonas Projekt DWMD 14 10 2010 15 51 51 CEST Zentrum Greifswak DVMD Pat ID aaa009 Zus 1D lt nicht gesetzt Formularfamilie Images Formular Imageform angelegt won Pr Dr Jonas am 14 10 2010 CEST Dokument Nr 484 1 Fig 52 An uploaded DICOM image after saving the form Via the DICOM icon you can open the integrated viewer important The integrated D
117. ur settings Once you have made the necessary settings click on the button ANALYSE If you want to upload another file instead of performing the import click on UPLOAD FILE AGAIN The analysis results show you whether the import was successful which discrepancies can be imported and which were discarded To finally save the import click on the Save button 14 10 2010 15 48 CEST fiza 7 PrO Jonas Secu ila DWD 14 10 2010 15 28 07 CEST MyAccount Messages Import Popods New patiant Select gt Import discrepancles Preview OTM 20100210 csr po 02 2007 rnp prchanarnese body wagh 1265 fi o c2 2007 npprahanarmeselethie 161268 02 06 2007 rinpprohanarnnesetextifield 468 1266 Altersangabe unklar Angabe priten Start analysis in line E fixed column sequence without columna headers 2 Column separator C comma f semicolon dabulatar t Others Column delimiter C quotation marks apostrophe nane C Others Refresh preview Upload file again Analyse Cancel Fig 12 Results of the import analysis All newly created and already existing discrepancies are listed by project on the Reports page On this page you can edit discrepancies or create queries Editing discrepancies In the DTM overview window discrepancies can be filtered according to certain criteria using the dropdown lists 14 10 2010 15 50 CEST Close i g Pr Dr Jonas seculrial DVMD 14 10 2010 15 38 07 CES
118. who have permis sion to access the patient in question If you have the required authorisation you can enter comments into the individual forms by clicking on the ComMENT button to the right of the respective question If a question contains several items you can select which of the individual items you wish to comment on When have finished making a comment and wish to save it click on Save You can delete incomplete entries if you have not saved them by clicking on CANCEL To read all of the comments in a form click on the COMMENTS button in the main menu at the top right of the page Click on CANCEL to return to the form or PRINT to print the comments If comments are created regarding items in a repetition group this group can no longer be fully de leted The DELETE button below the group if available deletes the data but not the actual group it self Once a comment has been made on an item the item or enclosing question cannot be hidden and possible matching Hide rules are ignored The form element will still be displayed even if a Hide rule will evaluate to true after a value change Queries Queries are a useful tool for monitors and other authorised users e g to initiate follow ups for unclear entries As a standard participant you can read and check queries In certain cases you may also be able to answer and close queries Every query has a unique identification number If the DTM see chapter 3 8 is used for a project
119. xt form return to the present form or return to the form overview page You may be asked about the occurrence of an AE or SAE and re directed accordingly Notes on filling out forms 5 The navigation buttons WELCOME HELP LoGouT etc are displayed at the top right of the main menu Additional buttons refer to the open form PRINT QUERIES COMMENTS and AuDIT TRAIL these only appear after the form has been saved for the first time You can also use the navigation bar at the top left of the screen to return to the welcome page or the form overview for that patient Click on PRINT to print the form this will print the version that was last saved in the database With the buttons QUERIES COMMENTS and AubiT TRAIL you can conduct queries add comments and view the Audit Trail of the current latest form see chapter 6 2 To the right of the individual questions you will find buttons for writing COMMENTS and or for editing QUERIES if your role gives you these rights In certain cases there will also be a button with which you can open a question based help window Details on these functions can be found in the chapter 6 2 At the bottom of the page you will find further buttons Click on CANCEL to leave the form without making changes to the medical data Click on Save to save the entered data in the form in the sec uTrial database Depending on your role rights and the configuration of the project further buttons may be available
120. y form by clicking on the link the patient has died or withdrawn from the study and has therefore been locked the form to which the discrepancy is linked has been locked either because it is has been manually locked or because it is currently being worked on by another user It is not possible to create a query until the form has been unlocked e When creating a query you can use either the predefined text of the discrepancy or your own text This will then be used as the question in the query The creation of a discrepancy from the DTM will be recorded in the Audit Trail of the respective form as a normal query If you would like to create queries for multiple discrepancies simultaneously activate the corres ponding check box at the beginning of the row next to the discrepancy or the check box All E Below the list you can select whether the respective discrepancy text from the list should be used or a standard text for all of the queries Enter this in the corresponding text field After clicking on the Ask Query button an editing lock will be imposed on the forms in order to cre ate the query The editable and non editable forms will then be listed and the query can be saved on all editable forms If an e signature is necessary for creating a query this must then be entered z If a query about a discrepancy is answered resolved or if a new search is initiated the status will be indicated accordingly in the overview
121. y individual changes deferred not possible 6 not necessary verified Fig 57 Selecting an SDV status for a form after changing individual items To perform a uniform status change for all of the items in the form select the option SET ALL STATES To from the dropdown list The radio buttons to the right will become active enabling you to select the applicable SDV status The third option in the dropdown list is a combination of both methods Select INDIVIDUAL CHANGES AND ALL NOT DONE STATES SET TO and the individually selected changes will be adopted In addition a uni form status can be selected for the remaining items Always click on SDV Save to save the changed status Click on CANCEL to discard the changes Performing an SDV at the form overview level The SDV can also be carried out summarily from the form overview of a patient An SDV can be per formed for a visit or for all patients by clicking on the respective status field see the circled options below After clicking on one of these options a page will be displayed for selecting the desired action n a 08 11 2010 11 23 CET Greifswald DYMD Pr Dr Jonas aaa009 B lt not set gt Secu Fla DYMD 08 11 2010 11 22 28 CET Patient Login EditWisitplan Patientfile New patient Select gt Visit plan AE Casenode form Images DVMD gt 1 visit 2 visit 3 visit Next visit Planned visits 01 01 00 15 01 00 14 04 00 Data entry 21 05 10 y
122. yed in DataCap ture in both the status header and in the form The randomization group will not be displayed In order to execute randomization with blinding a blinding list for this button must first be imported in the AdminTool and for stratification per centre the randomization numbers must have been assigned to the centres Randomization numbers can only be used once When they are assigned to a patient they will be marked in the list as used The centre assignment of used numbers cannot be changed Messages If a message has been configured for a specific number of remaining randomizations in the random ization configuration after the randomization an estimate will be performed of the remaining number of randomizations possible If this calculated number corresponds with the number configured for a randomization message a message will be sent accordingly Data entry and executing with hidden items Items and questions can be hidden and displayed with the rule type Hide when Display of the additional question Smoking occasions on a form Smoking habits only if one the values Light smoker Heavy smoker or Ex smoker has been specified In contrast to all other rules the Hide rule is evaluated directly in the client during the entry of values into a form a server contact is not necessary Conditions derived from values of other forms or visits are evaluated during the initialisation of the form during every form rel
123. yse button to launch the action The basic conditions for performing the action will first of all be checked e g form rights and patient status The entire patient will be locked for editing for the duration of the action If a patient form is currently being edited by another participant the patient cannot be locked for editing and will not be available for the mass action not editable The same conditions for performing an individual action in the patient apply for performing the selected action During the analysis a progress bar will be displayed After completion of the analysis an overview page will be displayed listing all editable and non editable patients and forms Forms will only be lis ted for which you has the corresponding rights for performing the selected action The details of the list can be viewed down to the individual form level This list can be downloaded as an Excel file Only patients and forms which can be edited will be used when carrying out the selected action m Date 29 01 2013 14 46 CET 58 C ll Fla Participant Dipl biol Susanne Schneider gt Welcome Fig 15 Example of the preliminary results of the analysis with a list of editable and non editable forms Mass Action Results of analysis Review A Total number of patients Editable Patients 5 Mot editable Patients o O OE Y Editable Patients 8 Ok 16 Not possible 12 WpU8b 0 Formulare rzv463 1 Formulare Ok lr S1 1 Formular

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