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User`s Manual - University of Pennsylvania

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1. Clear Go Investigator Comments Refresh _ Show Timestamps Visit Patient Number Name Date CRF Name Question Response Investigator Comments Last Modified Open CRF No data found Home Casebooks Review Reports Logout Preferences Change Password ContactUs Help About RDC 4 5 3 Copyright 2000 2007 Oracle All rights reserved 1 Use the Search section pane within Investigator Comments to view a sub set of data or all entered data 2 Click Go The Investigator Comments if there are any used for the study section displays the following data in the columns Patient Number Patient number for the query in this case there is one patient displayed on two rows Visit Name amp Date View the associated visit name and date of CRF entry CRF Name View the CRF Name of the Investigator Comment Question Hyperlink to open the Investigator Comment Detail for more information Response Hyperlink to view the Investigator Comment detail for more information Investigator Comment _ Display the associated comment for the Question Last Modified Display the date the comment was last modified Open CRF Open a DEW for the CRF and view the comment on the associated CRF V1 0 20120318 Oracle Clinical User s Manual Page 41 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Home Casebooks Review Reports ok Tis CRFs Discrepancies investigator Comments Special Listings
2. 11100 11101 11102 11103 Select AIl elec A O A Og O O O 111000 o 111001 O 111002 O 8 111003 Og 111004 E ia 111005 Oia 111006 if 111007 PEA 111008 Og 111009 Hid 111010 09 29 2009 11 51 52 09 29 2009 11 53 26 09 01 2009 14 30 35 09 15 2009 11 39 02 09 01 2009 10 45 49 09 21 2009 13 13 26 09 01 2009 14 30 35 09 01 2009 14 30 35 09 01 2009 14 30 35 08 06 2009 12 33 37 08 06 2009 12 40 04 08 06 2009 12 46 38 08 06 2009 12 53 03 08 06 2009 12 59 19 09 01 2009 10 34 49 Select Patients and Open Patient Casebooks v Go Home Casebooks Review Reports Logout About RDC 4 5 3 Preferences Change Password Casebook TTRIALS Provisional TTRIALS Provisional TTRIALS Provisional TTRIALS Provisional TTRIALS Provisional TTRIALS Provisional TTRIALS Provisional TTRIALS Provisional TTRIALS Provisional TTRIALS Provisional TTRIALS Provisional TTRIALS Provisional TTRIALS Provisional TTRIALS Provisional TTRIALS Provisional Contact Us Help SS noo Glo bal Links Logout Preferences Change Password ContactUs Help Logged in as Terry Church Data management role OCTRIALP Last Refresh 09 Oct 2009 09 38 51 Session 102315 Go Information Study and Site Summary Previous 1 1S0f25 Next10 Patient Search Tool Patient Snapshot Copyright 2000 2007 Oracle All rights reserved RDC Onsite organi
3. i a 39002 E i a 79003 E i p 99004 1 99005 1 99006 nb i 99007 i 99008 i 99009 i Select Patients and Generate Patient Data Report Go Add Visit Page Add Other Page The above view shows Discrepancies There are 4 CRF ICONSs displayed in the list above CRF level information is displayed in the Casebook Spreadsheet which means the red CRF ICON could represent a single discrepancy or multiple discrepancies For Patient level information detailing how many open discrepancies per CRF users would need to Search via the Review Tab More information can be found in the Discrepancy Management Section of this manual Entered There is one CRF ICON displayed in the list above Users could enter these CRFs if updates or additions to the previously saved data need to be performed Placeholder There are five CRF ICONs displayed in the list above for five available patient identification numbers There has been no data entered or saved for these seven CRFs V1 0 20120318 Oracle Clinical User s Manual Page 20 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Home Page Selection and Casebook data entry From the Home Page you can select a set of patients from the Patient Snapshot or Patient Selection List section Patient Selection List Select Patients and Open Patient Casebooks kd a Previous 1 50 of 401 Next 50 3 Select All Select None Seet Patient Number Last Modif
4. 11011 11012 Select V1 0 20120318 Select patient by checking the box in the first column Casebook Unassigned Unassigned Unassigned Unassigned Unassigned Unassigned Unassigned Unassigned Unassigned Unassigned Unassigned Unassigned Unassigned In Select Patients and select an action to execute on the patients from the dropdown menu Open Patient Casebooks open the casebooks for the selected patients Review Discrepancies review open discrepancies for the selected patients Review Entered CRFs review entered CRFs for the selected patients Review Investigator Comments review investigator comments for the selected patients s 1 50 0f 401 a Generate Patient Data Report generate general reports on participant data This feature is not being used for IDX Generate Blank Casebook Report generate blank CRF casebooks per patient This feature is not being used for IDX Oracle Clinical User s Manual Page 11 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Next 50 gt 100 Y Internet Protected Mode On ro Oracle Clinical Remote Data Capture RDC Onsite 4 6 Review MedDRA Dictionary AE review the coded Adverse Event information for the selected patients This feature is not being used for IDX Select Patients and Open Patient Casebooks Open Patient Casebooks Review Discrepancies Previous 1 500f401 v Next 50
5. Select Al Select None Select Review Entered CRFS fied f hok 7 Review Investigator Comments A Generate Patient Data Report 2 5044 IDX TEST 39001 02 20 2012 16 32 43 IDX TEST A 99004 03 07 2012 10 51 14 IDX TEST A 99003 03 06 2012 11 34 01 IDX TEST 99002 03 06 2012 10 16 05 IDX TEST V1 0 20120318 Oracle Clinical User s Manual Page 12 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Patient Icons Patient Number Last Modified Casebook Name The patient icon is represented by an anthropomorphic human looking figure The color of the icon signifies the discrepancy status or entry status of a given patient See table below i White Patient data contains no open discrepancies Gray with a No data has been entered for this patient question number The patient number is available to mark be used for a new patient Patient data includes discrepancies requiring your attention These are referred to as active discrepancies Patient data does not include active Yellow discrepancies but includes discrepancies requiring another user s attention These are referred to as ofher discrepancies The patient number or patient identification number PID is an assigned unique number for each patient unique to a given site The value in this field repress the date and time of the last modification to the patient s entered data A modification can represent any of the following actions data up
6. CRF There are four data entry statuses 1 created 2 blank 3 entry started 4 entry complete A location in the Question area of the Data Entry window in which you type a value that is the response to a CRF question A location in a form where a data value may be entered In most cases a data point corresponds to a field in the data entry window The process of changing a CRF that has been created and saved to the database by altering a data point and saving the new version of the CRF to the database Data that falls outside of an expected range of values or is otherwise flagged during the edit check process A process that systematically addresses discrepancies generated within a study Discrepancy management attempts to identify the cause and assess the implications of each discrepancy and determine an appropriate action for the discrepancy Its goal is to satisfactorily resolve all discrepancies associated with each CRF An entry which is part of the study database that defines the pertinent aspects of a discrepancy from its initial occurrence and through each action that is taken on it A designation that describes the current state of a CRF with regard to discrepancies There are four discrepancy statuses 1 none 2 closed 3 active 4 other Oracle Clinical User s Manual Page 49 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 E F electronic data capture EDC entry complete entry
7. Casebooks Go Previous 1 50 of 401 Next 50 gt If a list of items is longer than what can be displayed on the page or in a given box RDC Onsite will present you with navigational aids to help you view any additional data To navigate the Surround Pages use Arrows click the lt or gt symbols at the top or bottom portion of a given section to see the previous lt or next gt set of entries Hyperlink Text click Previous or Next at the top or bottom portion of a given section to see the previous or next specified number of entries Next 10 in the example above Drop Down List click the downward arrow next to the drop down box to select a different set of items V1 0 20120318 Oracle Clinical User s Manual Page 15 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 General Data Entry Instructions Data Entry within RDC Onsite is performed from the Casebook Page It is the only page in the RDC Onsite application where you can initiate data entry for a CRF Casebook Page Data Entry Casebooks Review 1 Click on the Casebooks tab to open the study Patient Casebooks Search and Casebook Spreadsheet display view ap TAX all ME Se elete ic Logout Preferences Change Password Help Home Casebooks Review Reports Logged in as Maria Blanco Data management role OCTRIALP Last Refresh 03 19 2012 13 06 32 Study and Site IDX_TEST v IDX 99 w Study and Site Summary Patient Casebooks TIP
8. Discrepancies e Closed Discrepancies e All Discrepancies e Investigator Comments e Audit History etc RDC Onsite highlights the associated fields accordingly facilitating a quick review of the CRF 2 Navigate to the highlighted field 3 If the field is red modify the data 4 Save the CRF If the new value is valid for a field the associated discrepancy will automatically close V1 0 20120318 Oracle Clinical User s Manual Page 46 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 List of Abbreviations Coordinating Center CDM CRCU CRF DEW DM DMS FDA ICH IE IFPMA INV CCEB Center for Clinical Epidemiology and Biostatistics Clinical Data Management Concomitant Medication Log Clinical Research Computing Unit Case Report Form Data Entry Window Data Manager Data Management System Food and Drug Administration ICH International Conference on Harmonization Internet Explorer International Federation of Pharmaceutical Manufacturers and Associations Investigator MedDRA Medical Dictionary for Regulatory Activities National Institutes of Health Oracle Clinical Oracle Project Administration Operating System PC Personal Computer Portable Document Format Principal Investigator Patient Identification Number Quality Assurance Quality Control RC SOM School of Medicine UPENN University of Pennsylvania V1 0 20120318 Oracle Clinical User s Manual Page 47 of 53 Orac
9. Oracle Clinical Remote Data Capture RDC Onsite 4 6 J Discrepancy Management Discrepancy management refers to an electronic process that systematically addresses data entry discrepancies within study CRFs Data entered into the RDC Onsite application is evaluated against a set of study defined expectations for each response field answer on the CRFs The application will trigger discrepancy management and create displayable messages regarding the discrepancy for reconciliation Discrepancy Types There are two types of discrepancies that operate within the RDC Onsite application Simple Univariate and Complex Multivariate discrepancies Simple Univariate Discrepancies that are dependent on the value of a single data point e Simple discrepancies usually relate to the format of the data entered to missing data in required fields or to an unexpected value entered into a defined field e Simple discrepancies are triggered in real time and cause a dialogue box to be displayed while the user is performing data entry Example Leaving an Inclusion or Exclusion criteria question blank on the Eligibility form Complex Multivariate are discrepancies that are dependent on two or more data point values which can be within a single CRF or across multiple CRFs and or visits e Complex discrepancies relate to missing data to data that does not correlate with other data within a CRF or across CRFs or to significant diffe
10. Oracle Pharmaceutical Applications Remote Da Charversrry of Patient Selection List Patients Select Patients and Open Patient Case a a a aE 100 Activities Select Patients and Open Patient Case eview 2 Active Discrepancies Review Investigator comments Home Casebooks Review Reports About RDC 4 5 3 This hyperlink will open the Review Active Discrepancies view of the Review Surround Page listing all active discrepancies across all patients and CRFs for the site Seas Oracle Pharmaceutical Applications Remote Data Capture OnSite Penn Logout Preferences Change Password ContactUs Help Home Casebooks Review Reports CRFs Discrepancies investigator Comments Special Listings Home gt Logged in as Terry Church Data management role OCTRIALP Last Refresh 14 Oct 2009 19 15 4 Discrepancies Study TTRIAL_PRESCR Site 108315 Patients Selected 1 TotalCRFs 1 TotalDiscrepancies 2 Search Refresh Patient Visit Number Name Date CRF Name Question Section Response Review Status Description Detail Open CRF SCRE 3 W 10001 SCREEN 07 14 2009 PSCR MULTI MULTI UNREVIEWED Please provide a response E SCRE 10001 SCREEN 07 14 2009 PSCR MULTI MULTI UNREVIEWED Please provide a response Home Casebooks Review Reports Logout Preferences Change Password ContactUs Help About RDC 4 5 3 Copyright 2000 2007 Oracle All rights reserved In the case above 1 Patie
11. Page within RDC Onsite Input Date Format Change the way the date is recorded during data entry The formats are US mm dd yyyy European dd mm yyyy and Swedish yyyy mm dd The STANDARD OPTION is US format mm dd yyyy Display date format Change the way the date gets displayed throughout the RDC Onsite application The formats are the same as described above Display time stamps in local timezone Display timestamps in the local time zone This will only affect audit trail information displayed such as Last Modified when looking at discrepancy information in the review tab APPLY to save any changes entered CANCEL to return to the previous page Change Password will allow the user to change their password as described in the Logging in section Contact Us will allow the user to email technical questions or issues directly to the Help Desk crcuhelo mail med upenn edu Help will allow the user to open a web based help dictionary on a variety of RDC Onsite related topics V1 0 20120318 Oracle Clinical User s Manual Page 9 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Participant Selection Patient Snapshot or Patient Selection List is located on the Home Page and lists a snapshot of patients for the site The Patient Snapshot consists of two components Patient Search and Patients Patient Selection List i Patient Search Patients Select Patients and Open Patient Casebooks a Previou
12. Special Listings View specialized questions Examples may include Adverse Events or Concomitant Medications with coding errors that need to be reviewed and updated Logout Preferences Change Password ContactUs Help Logged in as Terry Church Data management role OCTRIALP Last Refresh 14 Oct 2009 21 19 43 Special Listings Study TTRIAL Site 102315 GI TIP Perform search to retrieve patient data patient A Listing Type MERE v Visit Name Date CRF Name Row Verbatim Term Auxiliary Information Open CRF No data found Home Casebooks Review Reports Logout Preferences Change Password ContactUs Help About RDC 4 5 3 Copyright 2000 2007 Oracle All rights reserved NOTE Primarily CRCU staff only use this area therefore the functionality will not be described in detail V1 0 20120318 Oracle Clinical User s Manual Page 42 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Resolving Discrepancies After a CRF with a discrepancy has been found you will need to open it in a Data Entry Window DEW The CRFs with discrepancies can be opened from the Home Page Surround the Casebook Page Surround or the Review Page Surround as detailed in the previous sections Use the Navigator Pane to review in list format all Discrepancies or Investigator Comments if applicable for the study for a CRF By navigating through the list of Discrepancies or Investigator Comments you simultaneously navigate t
13. Unplanned CRFs represents the number of CRFs that were entered as unplanned visits per the existing study matrix Unscheduled Blood Draw Patient Death or CRFs that 7J 19 needed additional pages inserted Adverse Events Concomitant Medications With Active Discrepancies represents the number of CRFs that have open discrepancies TIP CRF level discrepancies only count forms with errors this summary report does not represent question level discrepancies within the CRF Example if a CRF has 5 open discrepancies on the individual questions within the CRF the statistic will be displayed in this summary view as 1 CRF with discrepancies With Other Discrepancies represents the number of CRFs that have open discrepancies related to AE coding errors or queries initiated by the DCC With no Open Discrepancies represents the number of CRFs without any currently open discrepancies V1 0 20120318 Oracle Clinical User s Manual Page 14 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Navigational Aids in the Surround Pages Patients Select Patients and Open Patient Casebooks Previous 1 50 of 401 v Next 50 3 Select All Select None Select ii Patient Number Last Modified Casebook r g9000 02 20 2012 15 04 41 IDX TEST im 99001 02 20 2012 16 32 43 IDX TEST E 99004 03 07 2012 10 51 14 IDX TEST 99047 Unassigned 99048 Unassigned 99049 Unassigned Select Patients and Open Patient
14. complete Save Incomplete Saving this CRF as Incomplete implies that you are not yet finished inputting responses and that you intend to complete the document at a later time Help Cancel Save Incomplete 5 Select Save Incomplete or Save Complete Save Complete indicates that all of the data for a CRF has been entered e Selecting this option if all the data fields for the CRF are complete e Discrepancy management will run on the CRF and highlight any discrepancies in red Any data changes made to a field after the CRF has been saved as complete will need to be documented in Audit Trail Dialogue boxes indicating the Reason for Change described in 5c of this section of the Manual Save Incomplete indicates that data has been entered but is not considered complete e Select this option to save entered data to the study database and that you intend to complete the document at a later time e The Audit Trail Dialogue does not pop up for any data changes or updates V1 0 20120318 Oracle Clinical User s Manual Page 30 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Navigating between CRFs While in an open Data Entry Window DEW you can move from one CRF to another without closing the DEW and reopening a new CRF 1 Click on the Previous CRF or Next CRF links in the upper right corner Previous CRF Next CRF The Previous CRF or Next CRF opens in the same DEW and will move you backw
15. from the Casebooks Page The link is disabled in the last CRF in a visit for a patient The CRF and the DEW closes The DEW toolbar are there to assist you in performing data entry The icons will be described in the sections of this Manual where their functions are utilized during data entry Next CRF TIP A few of the icons above require additional study privileges and may or may not function based on a users assigned role V1 0 20120318 Oracle Clinical User s Manual Page 26 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Navigating within the Case Report Form CRF The Case Report Forms CRFs within the Data Entry Window DEW are replicas of the paper based study CRFs General layout of the CRFs within the DEW Vertical Scrollbar Right of the open window if the CRF is too long to fit within the open DEW Horizontal Scrollbar Bottom of the open window if the CRF is too wide to fit within the open DEW Page Navigation In the DEW toolbar if a CRF has multiple pages The number of the current page is displayed against the total number of CRF pages Navigate using the Next Previous or Last Page icons See below Page Number of Pages ga G Page 1 2 Ea FF First Page Previous Next Last Page V1 0 20120318 Oracle Clinical User s Manual Page 27 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 General Data Entry with a Data Entry Window DEW Using the Keyboard Tab Move th
16. from the patient identifier list and also to define a range Blank patient Range fields indicate that all patients should be displayed Only entering one number in either the FROM or TO will return only that patient number Assigned Book The name of the patient casebook IDX study etc Show View three possible sets or groups of patients All all patients are shown This is the Default view Patients with data entered select this view to review data already entered On the Home Page and Casebook Page selecting this option will eliminate patient rows from view for those patients who have no saved data Patients with no data entered select this view when initiating data entry for new patients This view will only show patients who have no data entered and are available for data entry CRF Status Entry All Discrepancy All V Approval All Verification Al The search options of the CRF Status row Entry Status Select the entry status of CRFs for the study Each of these entry statuses have a corresponding ICON that is displayed in the Casebook Spreadsheet Icon CRF Label Description ob Placeholder No information has been entered The CRF contains required header field Created information but no response data has been entered wE 1E Blank The CRF is marked as blank All required CRF header and Section Entry header information is complete and at Complete least one question area response field
17. human participant in a study In RDC Onsite about whom data is collected Each patient in a study is assigned a unique patient number that is associated with a particular site In addition the patient number is also assigned to a particular case book The data that is collected about a participant in a study This includes demographic information and clinical results The set of patients that contain at leas one CRF which satisfies the search criteria A designation for a set of patient data that is unique across a give study Patient numbers are assigned to a study as part of the design process Alternative terms include patient positions enrollment number allocation number and randomization number The following rules apply to all patient numbers 1 Each patient number must always be assigned to a site 2 Each patient number may not be assigned to more than one site at a time 3 The first character in the patient number string may be a non zero numeric or an alphabetic character 4 If the first character in the patient number sting is alphabetic the second character must be a non zero character 5 Only the first character may be alphabetic Oracle Clinical User s Manual Page 51 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 pending changes privilege Q R query resolution resolution reason response value response sequence S T save save complete save incomplete site time
18. the appropriate role can generate Patient Data Reports NOTE This Feature is NOT available for all users Sections provide information and a snapshot of actionable items News No Records Found Activites Review Investigator comments Links Medication Reference Tool CRCU Adverse Events Coding Tool NIH News Details pertinent study site or database information published by the Data Coordinating Center DCC at the CRCU Clinical Research Computing Unit Examples of potential News items RDC Onsite system downtime for maintenance Training or Production Data Management System DMS being accessed specific site information and upcoming data related milestones etc Activities Provides customized tasks based on your role The tasks are displayed as hyperlinks Click the link Review Investigator Comments or Review Discrepancies to access the Review Page and activate the Review Discrepancies page to view only those that require your attention Links Reference links that are external to the RDC Onsite system These links can be private password protected or public sites V1 0 20120318 Oracle Clinical User s Manual Page 8 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Global Links are located across the bottom full list of links and in the right corner Subset list of links of each application page within RDC Onsite Home Casebooks Review Reports Logout Preferences Change Password ContactUs Hel
19. the choice that you assign to a parameter which was chosen from a list of possible values A clinical even which generally denotes the occurrence of a meeting between a patient and clinical staff at a study site In the course of a visit data related to the study is collected which at some point is recorded and saved to the study database In RDC Onsite a visit consists of one or more CRFs By default the system displays Spreadsheet Visit view in the Casebook Page which displays for the current patient list all of the CRFs collected for a single visit Oracle Clinical User s Manual Page 53 of 53
20. 005 Als 11006 E g 11007 O 9 11008 oO 11009 Select Patients and Generate Patient Data Report EE F k ob 1 ob ob 1 ob ob 1 k P Casebook View VIP HIP STUDY v v Go Add Visit Page Add Other Page Refresh VISIT 14 v Go Addvisit Page Add Other Page Refresh Casebook Spreadsheet overview Casebook Spreadsheet Patients Previous 1 4 of 4 S Next G Casebook View TRANS_MAPP_EP Y Select Patients and Generate Patient Data Report v Visit VIST 1 Visit BASELINE Go _ Add Visit Page _Add Other Page Refresh Select All Select None Patient Select G Number oO A 100001 F A 400002 rl is 100003 F 5 100004 Demo aS nb 1 ab 1 Symq Elig Fe ae Fe Ji 2 nbp 3 Fe p BA SELINE Medhx1 6 iar Ji at UCR Enroll lac Me be ob 5 be ob 5 Medhx2 Sc Pi F Fi Cmed ob 8 8 nb 8 Jj CRFs Y Previous Fjo J Ji Jl 1 1 of 1 Next x CRFs S Previous 1 10 of 20 yiNext Sstop ob 10 ob 10 JE isc e Casebook Spreadsheets displays patients in rows and the expected study related CRFs in columns e You can navigate across patients up and down and across visit specific CRFs left to right Casebook Spreadsheet controls To assist in navigating in the Casebook Spreadsheet you can make use of the controls loc
21. 009 The Patient CRFs section displays the following data in the columns Patient Number Patient numbers listed in descending order Visit Name amp Date Visit Name and Date CRFs entered CRF Name CRFs listed according to the order within a Casebook in this case there is only one CRF for this visit Casebook Casebook or Study information Date Modified Verified Approved amp Locked Dates of the most recent modification verification approval and lock Some of these dates may never be populated depending upon study use Open CRF Hyperlink to a Data Entry Window DEW to update data or review discrepancies V1 0 20120318 Oracle Clinical User s Manual Page 38 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Home Casebooks Review Reports onu CRFs f Discrepancies f investigator Comments Special Listings Discrepancies Access to Search Discrepancies ERE Pe Oracle Pharmaceutical Applications Remote Data Capture OnSite z E Charvarsrry oC TEHES TITANS Logout Preferences Change Password ContactUs Help Home Casebooks Review Reports Logged in as Terry Church Data management role OCTRIALP Last Refresh 14 Oct 2009 20 25 51 Discrepancies Study TTRIAL_PRESCR Site 108315 f TIP Perform search to retrieve patient data iz Search Patient Range Q oOo e Q Assigned Book Any CRF Status Entry All v Approval Al
22. 0120318 Oracle Clinical User s Manual Page 4 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 4 In the Log in box enter the Username and Password provided by the CRCU Database Administrator Login Username Password 5 Click Login Tip This Username and Password will be used for all applications It is important that you keep your login information confidential This information acts as an electronic signature and attaches your name to any changes updates additions or modifications within the Oracle Clinical system and can be tracked through the Audit Trail RDC Onsite displays the session information in the upper right hand corner of the Home Page under the global links Session information will be visible on every page throughout the RDC Onsite Application Username Role Database Last Refreshed Logged in as Maria Blanco Data management role OCTRIALP Last Refresh 03 19 2012 11 00 28 Study and Site IDX_TEST IDXii Study and SiteSummary Study Site Username Your first and last name Role Role corresponds to your username Different roles have different levels of access and privileges within the RDC Onsite application Database Displays the name of the database to which you are currently logged into Last Refreshed Displays the date and time the view was last refreshed in response to any action from you such as entering and saving data on a participant Study The name of the S
23. 02 2009 12 21 02 Value of abc for Jim Dattilo Discrepancy not Zip Code is not a reviewed by user valid NUMBER tep 5 After the discrepancy has been reviewed correct the data in the associated highlighted field appropriately A reason for change dialog box will appear 6 Save the CRF and the discrepancy will automatically close V1 0 20120318 Oracle Clinical User s Manual Page 44 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Using the Navigator Pane to Respond to Discrepancies In some instance data that triggered a discrepancy may be valid and you can document this within the Navigator Pane 1 Click a CRF icon to open it in the DEW 2 Open the Discrepancy Navigator and select the specific discrepancy 3 select Closed no resolution from the Action dropdown list at the bottom of the Discrepancy Navigator and then click Go A The Discrepancy Action dialogue box opens see example below ease specify Yes No e Less than high school High school or GED sf Some college Graduated from college university e Graduate or professional school Discrepancy Action Closed no resolution educational you have attained SHOR El t employment status Description Value of abe for Zip Code is not a valid NUMBER Review Status IRRESOLVABLE z ption Value of abc for Zip Code is not a valid NUMBER woe UNIVARIATE atus Discrepancy not reviewed by family in
24. COMPUTER DETECTION OF DIABETIC RETINOPATHY COMPARED TO CLINICAL EXAMINATION IDX Oracle Clinical Remote Data Capture RDC Onsite 4 6 User s Manual v1 0 20120316 Prepared by Clinical Research Computing Unit CRCU Center for Clinical Epidemiology and Biostatics CCEB University of Pennsylvania School of Medicine 3535 Market Street Suite 560 Philadelphia PA 19104 3309 cicu Clinical Research Computing Unit THESE DOCUMENTS ARE THE PROPERTY OF THE CLINICAL RESEARCH COMPUTING UNIT CRCU A DIVISION OF THE UNIVERSITY OF PENNSYLVANIA S SCHOOL OF MEDICINE AND THE CENTER FOR CLINICAL EPIDEMIOLOGY AND BIOSTATISTICS CCEB THESE DOCUMENTS CONTAIN PRIVILEGED PROPRIETARY OR OTHERWISE PRIVATE STUDY INFORMATION AND SHALL NOT BE REPRODUCED DISTRIBUTED DISCLOSED OR USED WITHOUT THE EXPRESS WRITTEN CONSCENT OF THE CLINICAL DATA MANAGEMENT DIVISION OF THE CLINICAL RESEARCH COMPUTING UNIT CRCU V1 0 20120316 Oracle Clinical User s Manual Page 1 of 53 Table of Contents SYSTEM REQUIREMENTS PERSONAL COMPUTER PC REQUIREMENTS LOGGING IN DATA MANAGEMENT SYSTEM DMS PASSWORD MANAGEMENT STEPS TO CHANGE PASSWORDS AFTER LOGGING INTO RDC ONSITE DMS NAVIGATION AND GENERAL OVERVIEW HOME PAGE IN RDC ONSITE HOME PAGE IN REVIEW PARTICIPANT SELECTION NAVIGATIONAL AIDS GENERAL DATA ENTRY INSTRUCTIONS CASEBOOK PAGE DATA ENTRY HOME PAGE SELECTION AND CASEBOOK DATA ENTRY CASEBOOK SPREADSHEET OVERVIEW CASEBOOK SPREADSHEET C
25. ONTROLS NAVIGATING WITHIN THE CASEBOOK SPREADSHEET DATA ENTRY WINDOW DEW OPENING A DATA ENTRY WINDOW DEW DATA ENTRY WINDOW DEW TOOLBAR NAVIGATING WITHIN THE CASE REPORT FORM CRF GENERAL DATA ENTRY WITH A DATA ENTRY WINDOW DEW ENTERING DATA IN A CRF NAVIGATING BETWEEN CRFS INSERTING CRFS ADDITIONAL CRFS AND UNPLANNED CRFS DISCREPANCY MANAGEMENT DISCREPANCY TYPES DISCREPANCY STATUS REVIEWING DISCREPANCIES CASEBOOK PAGE SURROUND DISCREPANCY REVIEW REVIEW PAGE SURROUND FOR DISCREPANCY REVIEW WORKING WITH THE REVIEW PAGE RESOLVING DISCREPANCIES USING THE NAVIGATOR PANE USING THE NAVIGATOR PANE TO RESPOND TO DISCREPANCIES USING HIGHLIGHTS TO REVIEW DISCREPANCIES LIST OF ABBREVIATIONS GLOSSARY V1 0 20120316 Oracle Clinical User s Manual Page 2 of 53 CONN DOD BP 10 15 16 16 21 22 22 23 24 24 26 27 28 30 31 33 35 35 35 36 36 37 38 43 43 45 46 47 48 Oracle Clinical Remote Data Capture RDC Onsite 4 6 System Requirements Personal Computer PC Requirements In order to operate the Oracle Clinical Remote Data Capture RDC Onsite application your computer must meet the following requirements Windows XP Home or Professional 2K or Windows 7 Internet Explorer IE 7 and 8 IE 9 certification pending Adobe Acrobat Reader or Professional 7 or above If Adobe is not installed it can be downloaded from the Adobe website http www adobe com Follow the insta
26. Perform search to retrieve patient data Izl Search Patient Range Q Q Assigned Book Any v Show All v CRF Status Entry All v Discrepancy All v Approval All v Verification All CRF Source Casebook All v Visit Aloo CRF Name All co Casebook Spreadsheet Set Visit Focus Patient All Casebook IDX TEST Visit Visit 1 Patients Previous Next CRFs Previous Next Patient Select amp Number Home Casebooks Review Reports Logout Preferences Change Password Help About RDC 4 6 4 Copyright 2000 2007 Oracle All rights reserved 2 To view patients data in the Casebook Spreadsheet either enter search parameters or click on Go in the Search section of the Casebook Page Search Patient Range Q Q Assigned Book Any V Show All v CRF Status Entry All v Discrepancy All v Approval All v Verification All v CRF Source Casebook All w Visit All v CRF Name All The features of this Search section are similar to the Search section on the Home Page V1 0 20120318 Oracle Clinical User s Manual Page 16 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Patient Range Q a i OQ Assigned Book Any M chow All l w The Search options of the Patient row Range Search a range of patient numbers in terms of FROM and TO Click the magnifying glass icon to select values
27. RF Source row Casebook Visit CRF Name will allow users to specify ALL or the study to which they are currently logged in to From the above users can select Casebook IDX TEST Riese Fok will allow users to select a specific visit name that will display CRF data in the Casebook Spreadsheet See below for an example users can select Visit VIST 1 will allow users to select a given CRF CRF Names can be found in the lower right hand corner of the paper CRFs used for data collection Below is an example of the CRF choices TIP The IDX study only has one Case Report Form CRF V1 0 20120318 Oracle Clinical User s Manual Page 19 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Search Patient Range Q Q Assigned Book Any il show All v CRF Status Entry All discevency All Approval All v Verification Al v CRF Source Casebook All vl visit Al V cRFName Al Clear Go In the above example the Casebook Search is set to default 1 Click Go to run the patient search with the default parameters All patient CRFs will be returned example below Casebook Spreadsheet Set Visit Focus Patient All Casebook IDXTEST Visit VISITi v Patients 1 10 0f 50 v Next CRFs Select Patients and Generate Patient Data Report v Add Visit Page Add Other Page Select All Select None Patient VISIT 1 Select Number cG a 2 B 1 a 373001
28. RFs 1 1 of 1 Select Patients and Generate Patient Data Report i Go Add Visit Page Add Other Page Refresh Select All Select None Patient VISIT 4 Select A Number EE To find patients with active discrepancies 1 Expand the Search section pane to specify a search for patients with active discrepancies 2 Select Open Active amp Other from the discrepancy drop down of the CRF Status row maa Patient Range 4 Assigned Book Any VY Show All v CRF Status Entry All Discrepancy A bl a 7 A S Verification All y CRF Source Casebook All Y pist All Active Other Open Active amp Other Clean None or Closed 3 Click Go The Casebook Spreadsheet will display only those CRF icons with active discrepancies Casebook Spreadsheet Set Visit Focus Patient All Casebook IDX TEST v Visit VISIT 1 v Patients 1 10 0f 50 Next CRFs l iofi v Select Patients and Generate Patient Data Report w Add Visit Page Add Other Page Select All Select None Patient VISIT 1 Select A Number cG a 2 E i V1 0 20120318 Oracle Clinical User s Manual Page 36 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Review Page Surround for Discrepancy Review The Review Discrepancies Page is especially useful in reviewing discrepancies across CRFs To access this page click on the hyperlink Review Active Discrepancies from the Activities section on the Home Page Penn
29. Y Oracle Pharmaceutical Applications Remote Data Capture OnSite Home Casebooks Review Reports Logout Preferences Change Password ContactUs Help Home Logged in as Terry ChurchiData management role OCTRIALP Last Refresh 05 Oct 2009 14 41 44 Change Password Cancel Apply Old Password t New Password Confirm Password Cancel Apply About RDC 4 5 3 Copyright 2000 2007 Oracte All rights reserved Home Casebooks Review Reports Logout Preferences Change Password ContactUs Help V1 0 20120318 Oracle Clinical User s Manual Page 6 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 DMS Navigation and General Overview Home Page in RDC Onsite Below is a snapshot of the RDC Onsite Home Page the following features will be described in more detail throughout this section e Tabs e Sections e Global Links e Patient Snapshot e Patient Search Tool e Session Information Tabs 248 L asr CNN rt Se LAVARSI sh TRUBS PITENT Home Casebooks Review f Reports News Patient Selection List Patient Search Oracle Pharmaceutical Applications Remote Data Capture OnSite Global Links Study and Site Activities H TEES Patients Sections Select Patients and Open Patient Casebooks yv Go Links Medica ence CRC Select None Adverse Events Coding Tool NIH Select Patient Number Last Modified
30. ab key to navigate from one field to another An action that commits pending data changes to the study database In PDF mode all save actions are explicit initiated by the user clicking the Save button or choosing to save pending changes through the save edits exit window A save action that causes RDC to assign the CRF to the entry complete data entry status A save action that causes RDC to assign the CRF to the entry started data entry status A clinical location that participates within a give study A significant even in the history of a CRF Used as criterion when viewing the Audit Trail tab Examples of timepoints include e creation date e verification dates e approval dates A value assigned to a datapoint that provides a chronology for significant events during a study Such events include the date time when a value was Created the date time when a value was updated etc Oracle Clinical User s Manual Page 52 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 U univariate discrepancy unplanned unplanned CRF unplanned visit update user role V validation validation error value visit V1 0 20120318 A discrepancy that is dependent on the value of a single data point This type of discrepancy is usually when the value recorded for a response does not meet certain criteria that has been deemed acceptable by the PI protocol or study sponsor A designation attributed
31. ard or forward through the CRFs displayed in the Casebook Spreadsheet These navigational links are restricted to CRFs for a single patient and visit and these links are only available to CRFs opened from the Casebook Page To change patients or visits Open additional DEWs for the patients and or visits 2 Select the CRF icon from the Casebook Spreadsheet or 3 Close the current DEW click the red X in the toolbar and open up a new DEW Updating Existing Data in a CRF Data updates for existing CRF data can be performed from either the Casebook Page or the Review Page within the RDC Onsite application To update a data field 1 Enter the CRF to be updated 2 Select the data field to be updated 3 Change the value of the response 4 Continue data entry if multiple values need to be entered or updated or click the Save button in the toolbar Depending on the status of the CRF RDC Onsite will respond accordingly CRF Previously Saved Incomplete the system will accept the updates and prompt you to save the data using either the Save Complete or Save Incomplete options CRF Previously Save Complete the Reason for Change pop up window will open Reason for Change Reason fe Wengen Comment optional Help Cancel OK V1 0 20120318 Oracle Clinical User s Manual Page 31 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 The Reason for Change is used as a way to provide additiona
32. ata Capture RDC Onsite 4 6 closed CRF header current current study D data entry mode data entry status data field data point data update discrepancy discrepancy management discrepancy record discrepancy status V1 0 20120318 A discrepancy status that indicates the relevant discrepancy is not actionable by any user group The discrepancy has been resolved either by a user or the system An area of a CRF which consists of information that identifies a given CRF and the data that it collects The information pertains to the patient visit investigator and site Much of the information included in the header is displayed in Patient Workbook Report which allows you to print a casebook for a specific patient In the data entry windows certain fields in the CRF header are required that is you must record that information before the system allows you to save the CRF RDC Onsite will not save a CRF to the study database until all required CRF header and CRF section header fields are collected A discrepancy stat that indicates action can be taken on the discrepancy either by a user or by the system The data set that is active The name of the current study is displayed in the title bar of the Main Application Window A designation that describes the method that is used to enter data into a CRF and save it to the study database A designation that describes the current state of data entry for a
33. ated in the top section Casebook Spreadsheet Patients Previous 4 4 of 4 Vl Next V1 0 20120318 Casebook View TRANS_MAPP_EP vl Visit BASELINE v Oracle Clinical User s Manual crFs Frevio us 1 10 of 20 Mi Net Page 22 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 The controls from left to right are Patients if the list of patients cannot fully be displayed use the up and down caret signs Previous and Next options located in the upper left of the Casebook Spreadsheet to navigate across the groups of patients Casebook View is the default Casebook or study a user is currently working in Visit allows the user to select a visit from the dropdown list to view the CRFs associated with the Visit CRFs if the number of columns viewable on screen is insufficient to show all CRFs for the visit selected use lt Previous or Next gt in the upper right of the Casebook Spreadsheet to navigate to visit CRFs that cannot be displayed in the current view Navigating within the Casebook Spreadsheet Visit Name CRF Names Patient SS Number Demo Syma Elig UCR Enroll Medhxi Medhx2 Cmed CRFs The information listed in the control section of the Casebook Spreadsheet corresponds to the spreadsheet view Visit Name displays the current Visit Name In the above example BASELINE is displayed CRF Names the CRFs associated with the Visit are displayed under t
34. ch you collect values that provide information about the CRF All required header fields must be collected before the system permits a CRF to be saved to the study database A question used with certain question groups that allows branching during data entry based on the response For example in a Drug Allergy question group an indicator question could be Are you allergic to any drugs e lf the response is Yes the remaining questions in the question group such as Drug Name and Type of Reaction require responses e lf the response is No the rest of the question group is not collected A set of possible values for a data field The list of values can generally be displayed by either clicking the button associated with list of value fields pressing the List button or by pressing the F9 key A discrepancy that is generated by a user rather than a data point value A manual discrepancy may be associated with an entire CRF a CRF header or a specific response in the question area of a CRF Oracle Clinical User s Manual Page 50 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 MedDRA The Medical Dictionary for Regulatory Activities is a pragmatic medically valid taxonomy of medical terms with an emphasis on ease of use for data entry retrieval analysis and display as well as a suitable balance between sensitivity and specificity within the regulatory environment It allows f
35. cle Clinical Remote Data Capture RDC Onsite 4 6 Data Entry Window DEW toolbar DEWs have a standard toolbar to facilitate work within the CRF E RDC Onsite DE 11000 VISIT 1 CG Windows Internet Explorer https t9 cceb med upenn edu olsa oc rdcOpenHtmlCrf do vobj RdcMPCasebookCrfDetailsVOl amp ppid 98790615 amp rdciid 0 amp crfname CG amp visitid 234315 amp subeventnumber 0 amp bookid null amp casebookinview 1600158 amp iscrfse 4 pk ORACLE RDC Onsite Data Entry Preferences Help Study IDX_TEST Site IDX 11 Patient 11000 Casebook IDX TEST Maria Blanco Data management role EE Previous CRF Next CRF ER Highlight All Discrepancies Reif Bis BB GR Gy page 12 Gy amp x The DEW toolbar icons are described below Add Discrepancy The Add Discrepancy window opens i TUETAAN The Add Update Investigator Comment window opens p i 5 peeter Row The Delete Row Tne DeleteRow dialog opens opens be Brank Fiag Toot Flag Tool The CRF Blank Selecton s Processing dialog opens CRF Blank Selection s The CRF Blank Selecton s Processing dialog opens dialog opens Verification The Verify CRF window opens Approval History The ne Approve CRE window opens CRF window opens Te ne eaen a to the previous CRF This link appears only if a CRF is opened from the Previous CRF Gasebooks Page The link is disabled in the first CRF in a visit for a patient Navigate to the next CRF This link appears only if a CRF is opened
36. come In U S dollars ple Comment 1 method optional USET Resolution apn Data Type Reason refit 5 Resolution Byelim Dattilo Comment s Te mbers ever been diagnosed with Pain moa E PBS Interstitial Cystitis IC e mbers ever been diagnosed with Chro Cer anne Sarees t Diecres luti ip S Chronic Prostatis CP REMEMGEG COMMENT TOT SUBSEQUENT VIECTEpancy resolution a or ID 3 0l rt j e OF Parner iel Cancel e 4 Supply a Resolution Reason and add a Resolution Comment 5 Click OK C 10 001 to 25 000 25 001 to 50 000 L L L Type UNMWARIATE Review Status Irrezolable 50 001 to 100 000 More than 100 000 Prefer not to Answer The field highlight will switch from red to green and the Navigator Pane will display the Review Status as Irresolvable Resolution Comment Correct Reason Data Type Comment Resolution Reason CRA Correction By Terry Church 6 Save the CRF for the changes to take effect V1 0 20120318 Oracle Clinical User s Manual Page 45 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Using Highlights to Review Discrepancies RDC Onsite highlights information in a CRF in different ways To review a CRF using this feature 1 Select the type of information to highlight from the Highlight dropdown selection list in the DEW toolbar ORACLE RDC Onsite Data Entry Options are e None e Active Discrepancies e Active and Other
37. cord associated with a patient in a study Its purpose is to facilitate accurate collection of clinical data CRFs are accessed through the PDF data entry window A constituent of an audit record A standardized entry that explains why a datapoint changed The change reason can be supplied either automatically system provided or manually user provided A user supplied change reason is required when patient data changes after the CRF reaches entry complete data entry status The Clinical Research Computing Unit CRCU is a designated core research facility providing state of the art scientific services related to clinical data management and research computing The CRCU is staffed with project management clinical data management and research computing professionals who support the development and implementation of large scale multi center clinical trials collaborative clinical and patient oriented research and multi institutional health services research projects for Penn Medicine which encompasses the CCEB the School of Medicine and the University of Pennsylvania Health System UPHS The development and support activities of the CRCU involve application development database administration project management clinical data management research computing and technology support services Abridged version of the Glossary from the RDC User Guide V1 0 20120318 Oracle Clinical User s Manual Page 48 of 53 Oracle Clinical Remote D
38. dates discrepancy resolution or initial entry of a CRF The casebook name is the name of the casebook or CRF packet to which a given PID has been assigned In the case above all the patients have been entered into IDXS Provisional Provisional casebook is currently being developed enhancements are being made or testing is being performed Data entered into a provisional casebook is committed into a study database but can be removed prior to activation Active casebook is currently active or live Data entered into an active casebook will be committed to the study database any subsequent changes to data will be tracked via the audit trail Site and Study Summary is shown below the Session information on the Home Page Logged in as Maria Blanco Data management role OCTRIALP Last Refresh 03 19 2012 11 00 28 Study and Site IDX_TEST W Dii Study and Site Summary m To view Study and Site Summary information click on the Study and Site Summary hyperlink below the Session information from any of the Surround Pages Study and Site Summary information will give a snapshot of data related to Study Summary provides number of sites number of patients with data number of CRFs and Site Summary V1 0 20120318 number of discrepancies provides the name of the Investigator address of the Investigator patient summary information number of CRFs with discrepancies and number of discrepancy fr
39. e PRE a 10001 SCREEN 07 14 2009 PSCR MULTI MULTI UNREVIEWED Please provide a response E E Sort or Search by o Patientto view a list of all discrepancies sorted by patient o Visitto view all discrepancies for a given Visit across patients o Review Status to view which discrepancies are currently open or currently in review o Description to find any view discrepancies based upon their error message V1 0 20120318 Oracle Clinical User s Manual Page 40 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Home Casebooks Review Reports ooo ss sempmene ra ae sent Investigator Comments View field level comments or notes that an Investigator Monitor or Reviewer deems appropriate to be included for a given value This feature may or may not be used for a particular study 218 a Penn Oracle Pharmaceutical Applications Remote Data Capture OnSite MY OF TREHKEATI TENTA Logout Preferences Change Password ContactUs Help Casebooks Reports CRFs Discrepancies Investigator Comments Special Listings Logged in as Terry Church Data management role OCTRIALP Last Refresh 14 Oct 2009 21 06 19 Investigator Comments Study TTRIAL Site 102315 TIP Perform search to retrieve patient data Patient Range Q Q Assigned Book Any v CRF Status Entry All l Discrepancy All v Approval All w Verification All l CRF Source Casebook All x Visit All i CRF Name All v
40. e cursor to the next data field available for data entry The opened field will be outlined in gray Shift Tab Move the focus to the previous data entry field The opened field will be outlined in gray Spacebar Toggle a checkbox field on or off Using the Mouse Left Click Open the field for data entry The opened field will be outlined in gray Date Fields Click on the calendar icon to the right of the opened field to access the pop up calendar window Year Selection Month Selection Increase Decrease Drop Down Box Arrows Previous Month viou Next Month Arrow Aa 4 October iw 2009 e D SUN MON TUE WED THU FRI SAT 12 3 4 5 6 7 8 9 4 Today s date Ei 12 13 14 15 16 LL i 48 19 20 24 22 23 25 26 27 28 29 30 Navigate to the appropriate Month Month Selection Drop Down Box and Year Year Selection Increase Decrease Arrows Click on the Day and the date will populate in the field or manually enter the date in the opened date field instead of opening the calendar pop up window V1 0 20120318 Oracle Clinical User s Manual Page 28 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 List of Values some fields have lists of study defined values associated with the data entry field A magnifying glass icon at the right of the opened field indicates the field has an associated List of Values LOV Click on the icon to access a pop up LOV window Acceptable List Of Va
41. e for data entry Discrepancy Status View patients with discrepancies From the Home Page view the results appear as patient V1 0 20120318 Oracle Clinical User s Manual Page 10 of 53 Patients level discrepancies patients with discrepancies other pages within the RDC Onsite application display results CRF level discrepancies The discrepancy statuses are All all patients regardless of their discrepancy status are displayed This is the default value Active display only patients with active discrepancies These discrepancies are based on logic checks range checks and other study defined criteria per CRF Other display only patients with other discrepancies These are system based discrepancies AE Coding in Progress AE Event Not Found or are manually created to obtain further information about a given variable Open Active amp Other display open discrepancies that are active and other Clean None or Closed retrieve patients with no open active or other discrepancies Provides brief information about each patient depending upon the search criteria selected The description below refers to patients for a site that have had no search criteria entered Patient Selection List i Patient Search Patients Select Patients and Open Patient Casebooks hi Select Al Select None Select 1 Patient Number Last Modified 11000 11001 11002 11003 11004 11005 11006 11007 11008 11009 11010
42. ee CRFs Oracle Clinical User s Manual Page 13 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Study and Site Summary Study Summary IDx Test Study Total Sites 7 Planned 5 Not Verified 5 Patents Created 2807 Unplanned 0 Awaiting Re Verification O Patients Enrolled O Total 5 Verified O Patients With Data 5 Locked O NotLocked 5 With Active Discrepances 4 Not Approved 5 With Other Discrepancies 0 Awaiting Re Approval O With no Open Discrepancies 1 Approved 0 Site Summary IDX 99 Investgator Dr Maureen Maguire Patients Created 401 Investigator Address Philadelphia PA USA Patients Enrolled 0 Patients With Data 5 Site CRF Information Planned 5 Not Verified 5 With Active Discrepancdes 4 Not Approved 5 Unplanned Awaiting Re Verificaton 0 With Other Discrepances 0 Awaiting Re Approval O Verified O With no Open Discrepancdes 1 Approved Locked O MotLocked 5 Nobe This report may indude counts of CRFs and discrepancies that you do not have the required access to view depending upon your user account configuration Print Close General terminology from the display above Patients Created indicates the number of patient numbers that have been pre programmed for the study and for the site Patients with Data represents the number of created patients that have at least one CRF entered and saved in the system Planned CRFs the number of CRFs that have been allotted or planned per visit per patient
43. en CRF or set of CRFs The Approval ICONS are Icon Label Description rrr s None The CRF has not been approved rrr Approved The CRF has been approved At least one data point in the approved mE Re approval eu Required CRF has been modified since approval The CRF must be re approved TIP DX does not currently have any study specified elements that require electronic approval and this feature of the Search section will not return any associated data Keep Approval Status set to the default of ALL or use NONE when searching CRF Status Verification Status View CRF Verification Status for those CRFs that require Principal Investigator PI or Study Monitor verification of some aspect of data collected a given CRF or set of CRFs The Verification Status ICONS are icon Label Description rrr s None The CRF has not been verified Verified The CRF has been verified At least one data point in the verified aves Re verification CRF has been modified since mA Required verification The CRF must be re verified TIP DX does not currently have any study specified elements that require additional verification and this feature of the Search section will not return any associated data Keep Verification Status set to the default of ALL or use NONE when searching CRF Status V1 0 20120318 Oracle Clinical User s Manual Page 18 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 The Search options for the C
44. evious 4 10 0f 11 Next Casebook View VIP HIPSTUDY Select Patients and Generate Patient Data Report v Go Add Visit Page Add Other Page Refresh Select All Select None Select 4 oa oO Patient Number 11000 11001 V1 0 20120318 VISIT 1 ORACLE RDC Onsite Data Entry Visit VIST 1 Study IDX_TEST Site IDX 11 Patient 11000 Casebook IDX TEST Maria Blanco Data management role i a ER Page 12 EX A Highlight All Discrepancies IDx 11000 ID Alpha Code Subject s age Gender check one O E Female Male Is the subject Hispanic or Latino check one Hispanic or Latino O Not Hispanic or Latino _ Unable to answer C Subject s race check all that apply a White b Asian c Black or African American d American Indian or Alaskan Native e Native Hawaiian or Pacific Islander f Unable to answer Does the patient report recent loss of vision a es a Is visual acuity 20 40 or better Eligibility checklist complete Patient eligible Ocular Assessment Assessment MUST be made without looking at photographs 8 Retinopathy status pick one answer for each eye Oracle Clinical User s Manual Alpha Code Right Eye Left Eye O S E O Yes No Yes O O Yes No Yes Fi No O No CRFs SY CG 02 06 2012 O O gt stop Yes No Right Page 25 of 53 TEVIOUS 1 1 of 1 vw Ney Ora
45. he Visit Name CRFs the CRFs for the patient row are displayed with their appropriate icon The CRFs can represent Empty CRFs or Entered CRFs Clicking on one of the CRF icons will allow the you to perform data entry on the CRFs for a given patient The numbers beside the CRF icons act as sequence numbers for ordering and displaying the CRFs within a Casebook V1 0 20120318 Oracle Clinical User s Manual Page 23 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Data Entry Window DEW e In RDC Onsite the Data Entry Window DEW opens a pop up window from the Casebook Surround Page e Users can have up to three DEWs open at a time which operate independently of the Casebook Surround Page The pop up windows have the following functionality e Ability to navigate between the RDC Onsite application tabs while the DEW windows are open This gives users the ability to access other areas of the application while the DEW is running without worrying about losing data or not having the ability to continue performing data entry while browsing the application e All pop up windows opened will remain active until the window is closed Each of these pop up windows will display a unique name displayed in the Internet Window Header and also in the Windows Taskbar at the bottom of the screen E RDC Onsite Patient Casebooks Windows Internet Explorer provided by Comcast da Y F BRO rr cen Ineo eduinlsalar
46. hrough the associated fields in the CRF Asian Asian American Black African American Native Hawaiian or Other Pacific Islander White Caucasian Other Please specify 7 0 0 5 What is the highest educational you have attained 6 What is your current employment status 7 What is your annual family income In U S dollars please see the MOP for conversion method 8 What is your ZIP US 9 Have any family members ever been diagnosed with Painful Bladder Syndrome PBS Interstitial Cystitis IC 10 Have any family members ever been diagnosed with Chronic Pelvic Pain Syndrome CPPS Chronic Prostatis CP 11 Living with a spouse or partner 12 Research Coordinator ID Yes No Yes No Yes C No Yes No Yes No Less than high school High school or GED Some college Graduated from college university Graduate or professional school after college university gogogo OOWOO Employed Unemployed Retired Fulltime homemaker Disabled 10 000 or less 10 001 to 25 000 25 001 to 50 000 50 001 to 100 000 More than 100 000 Prefer not to Answer OOONOO OOOO Yes O Yes Yes LJ No No E Unknown No CI Unknown DEMO Using the Navigator Pane 1 2 A Discrepancy Investigator Comment Show AllD l List iscrepancies v Zip Code UEscrip History ription Value of abc for Zip Code is e ot a valid NUMBER ppe UNVARL TO o PK s _ Status Discrepancy
47. ied Casebook E A 11000 Unassigned E 11001 Unassigned E 11002 Unassigned E Fy 11003 Unassigned E 11004 Unassigned E 11005 Unassigned E 11006 Unassigned E 11007 Unassigned E 11008 Unassigned E 11009 Unassigned E 11010 Unassigned E 11011 Unassigned El i 11012 Unassigned Internet Protected Mode On fg 100 1 Select the set of patients you d like to perform data entry for these can be either patients with current data continuing data entry or patients with no data entered new patient data entry 2 From the Drop Down box choose the Open Patient Casebooks option V1 0 20120318 Oracle Clinical User s Manual Page 21 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 3 Click on the Go button to be taken to the Casebook spreadsheet for the selected patients ep eya all Ml Se ielede Home Casebooks Review Reports Home gt Patient Casebooks Logout Preferences Change Password Help Logged in as Maria Blanco Data management role OCTRIALP Last Refresh 07 19 2011 10 53 Study and Site VIP_HIP v VIP HIP 11 Study and Site Summary Search 50 Patients Selected From Home Page ccc rr Casebook Spreadsheet Previous 1 10 of 50 Next Select Patients and Generate Patient Data Report Patients Select All Select None Patient Select A Number g A 11000 E g 11001 g a 11002 Ais 11003 g 3 11004 Mis 11
48. is completed The second pass of data entry has started This record originates from an de Pass 2 aa Started Oracle Clinical operation but your sponsor might create an activity that displays records with this status The second pass of data entry is m gt completed This record originates from Complete an Oracle Clinical operation but your sponsor might create an activity that displays records with this status A Batch The CRF s data was batch loaded This loaded is a sponsor s operation TIP DX uses single data entry and therefore the following ICONS will not be displayed used o Pass 2 Started o Pass 2 Complete V1 0 20120318 Oracle Clinical User s Manual Page 17 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Discrepancy Status View CRFs with discrepancies From the Casebook Page view the results appear as CRF level discrepancies The discrepancy status ICONS are Icon CRF Label Description There are no Other or Active discrepancies associated with the CRF Note that there may be closed discrepancies associated with the No Discrepancies CRF There is at least one Active a Active discrepancy in the CRF to be addressed by you T There is at least one discrepancy that Other must be addressed by a user in a role other than yours Approval Status View CRF Approval Status for those CRFs that require Principal Investigator PI approval of some aspect of data collected on a giv
49. l information regarding changes made to data that has been Saved Complete This additional information along with the prior value and updated value gets added to the Audit Trail history and allows for a more comprehensive understanding for data changes made at the site level To complete the Reason for Change 1 Click the downward arrow beside the Reason field to view a dropdown list Ei REASON CRA Correction v zi Reason for Change Comment optional Data Entry Error CRA Correction Inv consulted CRA Correction Src Data consulted Investigator Correction Study Assumption Thesaurus Clarification Analysis Correction Help Validation Status changed Data Entry Mode 2 Select a reason from the dropdown list to populate the Reason field This is a mandatory field and RDC Onsite will not accept the change without a Reason 3 Enter a comment in the Comment text box Use this comment field to provide additional information if needed about the change being made 4 Click OK to process the data change V1 0 20120318 Oracle Clinical User s Manual Page 32 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Inserting CRFs Additional CRFs and Unplanned CRFs Depending on the needs of a study you can add additional CRFs or add unplanned CRFs to a visit To add additional CRFs 1 Select a visit value from the Visit dropdown list in the control box area of
50. l w Verification an v CRF Source Casebook All i Visit All v CRF Name All v x Discrepancy Status All Clear Go Discrepancies Refresh Patient Visit Number Name Date CRF Name Question Section Response Review Status Description Detail Open CRF No data found Home Casebooks Review Reports Logout Preferences Change Password ContactUs Help Copyright 2000 2007 Oracle All rights reserved About RDC 4 5 3 1 Use the Search section pane within Discrepancies to view a sub set of data or all entered data 2 Click Go The Discrepancies section will display information about the Search selection criteria The detail below shows that for this study there is 1 patient 1 CRF and 2 total discrepancies Discrepancies Study TTRIAL_PRESCR Site 106315 Patients Selected 1 Total CRFs 1 TotalDiscrepancies 2 Search Patient Range Q Q Assigned Book Any v CRF Status Entry All Approval All i Verification All v CRF Source Casebook All vi Visit All v CRF Name All v Discrepancy Status A Clear Go Di ies Refresh Patient Visit Number Name Date CRF Name Question Section Response Review Status Description Detail Open CRF cs 2 i 10001 SCREEN 07 14 2009 PSCR MULTI MULTI UNREVIEWED Please provide a response SCRE 1 E 10001 SCREEN 07 14 2009 PSCR MULTI MULTI UNREVIEWED Please provide a response The Discrepancies section di
51. le Clinical Remote Data Capture RDC Onsite 4 6 Glossary A B Active audit trail history audit trail record Blank Cancel cancel button Casebook case report form CRF change reason Clinical Research Computing Unit CRCU A discrepancy status that indicates the relevant discrepancy is actionable by members of your user group The set of all audit records for a given datapoint A set of information that describes an instance of data update Each audit record includes the following information e the current value of the datapoint the previous value of the datapoint the username that changed the datapoint the timestamp the data update occurred the change reason an optional comment An entry status designation that is assigned to a CRF a user has defined as blank A Blank CRF does not contain data nor can data be collected while it is marked as blank A user action that halts the current process or action and reverts to the state of the application that immediately preceded the process or action without changing the status of the system or data In a dialogue or pop up window a cancel button causes the application to dismiss the window disregard changes made in the window and revert to conditions that existed before the window opened The set of CRFs that are used to collect data for a patient over the course of the study Each patient is assigned to a particular case book A paper or electronic re
52. llation instructions provided on the Adobe website If the internet browser s popup blocker is enabled make sure to allow popups from the following websites http rt4 cceb med upenn edu and http rt9 cceb upenn edu Disable Yahoo Search Google Toolbar AOL Toolbar Windows Messenger add ons To disable them in IE 6 the add on needs to be removed using the Control Panel s Add or Remove Programs tool To disable then for IE 7 or above go to the Tools menu and select Manage Add ons click on the add on and check Disable Repeat for each add on found You need to restart IE for the changes to take effect V1 0 20120318 Oracle Clinical User s Manual Page 3 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Data Management System DMS 1 Access the Login Page of RDC Onsite by entering the following URL https rt9 cceb med upenn edu olsa oc rdcLogin do for RDC Onsite 4 6 into an Internet Explorer web browser 2 Enter user name and password 3 Click Login to launch the application Tip Users can also bookmark the above address in the Internet Favorites of their browser ORACLE RDC Onsite Login Help Copyright 2000 2007 Oracle All rights reserved This will allow access to the IDX training database initially and after certification you will be given access to the live study database A News Item next section will describe which database is being accessed V1 0 2
53. lues Select Display Seq Value Description 1 1 Every day 2 A few times per week A few times per month infrequently PRN Click the radio button in the SELECT column for the answer of a ROW The VALUE field in the LOV pop up indicates the numeric value of the answer associated with the paper based CRF the small number to the right of a check box or manually enter this number in the opened field instead of using the LOV pop up window V1 0 20120318 Oracle Clinical User s Manual Page 29 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Entering data in a CRF All CRFs either Empty or Entered contain basic study related information Study Name Logo Site Name Number Patient Identification Number PID CRF Name etc You are only required to enter responses to the remaining CRF questions To enter data in a CRF 4 Click on a field to enter or update information _ Enter the data 2 3 Use the Keyboard or Mouse to navigate from the field after adding or changing a value 4 After all of the data has been entered or updated click on the Save Data Icon in E the toolbar Confirm Save Data using the Save Complete pop up window JA Save Complete x 1 Prior to saving this CRF data you may specify whether you wish to mark this data as being complete Save Complete Marking the CRF as being complete implies that you have met the requirements of the form and consider your responses
54. not reviewe bye e r e user Reason Data Type By Jim Dattilo Date 10 02 2009 12 21 02 m O Action Click the arrow on the right edge of the DEW to open close the Navigator Pane Select a tab either Discrepancy Navigator or Investigator Comments Navigator Discrepancy Investigator Comment Show All Discrepancies b 0 1 Zip Code There are two sub panes of the Navigator List and Details These sub panes help organize information and facilitate movement in the open CRF Click the nodes or next to the List or Details in the title bar of the sub pane to collapse or expand the sub pane windows o List Lists discrepancies or investigator comments according to the tab selected Click an item in the list to review the associated field within the CRF and activate the Details sub pane o Details View details of a selected discrepancy or investigator comment within this sub pane A scroll bar at the right edge of the sub pane allows you to scroll through Details V1 0 20120318 Oracle Clinical User s Manual Action b Page 43 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 b Asian Asian American O Yes No eee Investigator Comment c Black African American O Yes No lt a d Native Hawaiian or Other Pacific Islander Yes O No Show eee ee v e White Caucasian L Yes No A ee A f Other Please specify C Yes No 5 What is the highest educational y
55. nt 1 CRF 2 Total Discrepancies V1 0 20120318 Oracle Clinical User s Manual Page 37 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Working with the Review Page The Review Page Surround provides easy access to review data entered in RDC Onsite via one of the 4 topical areas Home Casebooks Review Reports Discrepancies investigator Comments Special Listings CRFs View Audit Trail History about CRFs that have been entered and saved 1 Use the Search pane of the Patient CRFs to view a sub set of data or all entered data 2 Click Go The Patient CRFs section will display information about the Search criteria The screen below shows that for this study there are 3 current patients with data Patient CRFs Study TTRIAL_PRESCR Site 108315 Patients Selected 3 TotalCRFs 3 Search Patient Range S4 A Assigned Book Any v CRF Status Entry All v Discrepancy All v Approval All v Verification All v CRF Source Casebook All Visit All w CRF Name All v Clear Go Patient CRFs Select CRFs and Generate Patient Data Report i Go Refresh C Show Timestamps Select All Select None Patient Visit Date Open Select Number Name Date CRF Name Casebook Modified Verified Approved Locked CRF E 10001 PRE SCREEN 07 14 2009 PSCR TTRIAL_PRESCREEN 07 14 2009 Ej F 10002 PRE SCREEN 07 14 2009 PSCR TTRIAL_PRESCREEN 07 14 2009 F 10003 PRE SCREEN 07 14 2009 PSCR TTRIAL_PRESCREEN 07 14 2
56. og 6 Select a sub visit from the dropdown list to add to the current visit The new CRF is identified accordingly For example if the sub visit is 1 and the CRF is CMED the new visit page is CMED 1 a RDC Onsite Add Visit Page Webpage Dialog http rt cceb upenn edu olsa oc rdcModalWindow do page CRFLovvVisit Add Visit Page study WIP_HIP Sie VIP HIP 11 wist VISIT 4 Patient 17000 Selected CRF EE Select Sub visit Cancel Apply http rt cceb upenn edu olsa oc rdcModalWindow Internet T Return to the Casebook Spreadsheet to view the new empty CRF icon in the designated patient row and CRF column Notice that a new CRF column may have been inserted and labeled with both the CRF name and the sub visit number Casebook Spreadsheet Patients 1 4 of 4 MN Casebook View TRANS_MAPP_EP M Visit BASELINE v CRFs Previous 21 21 of21 v Nexl Select Patients and Generate Patient Data Report Go Add Visit Page Add Other Page Refresh Select All Select None Patient BA SELINE Select amp Number Cmed 1 C 100002 F is 100003 C 100004 8 Click the new CRF icon to open the CRF in Data Entry Window DEW 9 Enter data and save the CRF e The patient makes an unscheduled visit examples Unplanned Blood Draws In this case the sub visit number correlates to a visit that happens after Visit X and Before Visit Y V1 0 20120318 Oracle Clinical User s Manual Page 34 of 53
57. olution of discrepancy data updated or modified in accordance with edit checks The red highlight of the field will disappear if a discrepancy has been resolved e Affirmation of discrepancy an open discrepancy based on unexpected data results entered into CRF fields can be confirmed to be valid values and the discrepancy can be Closed with no resolution These fields will be highlighted in green V1 0 20120318 Oracle Clinical User s Manual Page 35 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Reviewing Discrepancies In this section finding and reviewing discrepancies will be discussed Discrepancies can be reviewed from the two Surround Pages Casebook Page and Review Surround Page differently to identify CRFs containing active discrepancies Casebook Page Surround Discrepancy Review The Casebook Surround Page organizes CRF icons in patient rows and CRF columns in casebook order This organization can be useful in managing discrepancies on a patient by patient or visit by visit basis Study and Site Summary Patient Casebooks Search 50 Patients Selected From Home Page Patient Range Assigned Book Show CRF Status Entry All Discrepancy All Approval All Verification All v CRF Source Casebook An v Visit All v CRF Name an in Clear Go Casebook Spreadsheet Hrn 1 10 of 50 Next Casebook View VIP HIP STUDY v visit vist 1 v C
58. or uniform coding and reporting of medical signs symptoms and body systems for Adverse Event AE reporting It was developed by the International Conference on Harmonization ICH and is owned by the International Federation of Pharmaceutical Manufacturers and Associations IFPMA acting as trustee for the ICH steering committee multivariate discrepancy A discrepancy that is dependent on two or more data point values N O news item open P parameter patient patient data patient list patient number V1 0 20120318 which can be within a single CRF or across multiple CRFs and or visits A multivariate discrepancy is generated when a CRF is saved which causes the system to run the validation procedures that locate this type of discrepancy A message that is communicated by the study sponsor to some portion of its RDC Onsite application users News items are displayed in the News window A designation for a discrepancy that indicates it is either in the active or other discrepancy status that is it is actionable by a user group A designation for a CRF that indicates it contains at lease one active or other discrepancy A component of a criterion that you use to define a specific property of the data you wish to comprise the workset A parameter may be comprised of settings that represent a value or range of values that when combined with any other parameters in the same criterion define specific data A
59. ou have attained L Less than high school High school or GED L Some college L Graduated from college university C Graduate or professional school after college university 6 What is your current employment status Employed C Unemployed C Retired Full time homemaker L Disabled x 7 What is your annual family income In U S dollars please seethe _ 10 000 or less p Mise MOP for conversion method C 510 001 to 25 0 Description Value of abc for Zip Code is not a valid NUMBER Type UNIVARIATE Review Status Discrepancy not reviewed by user 8 What is your ZIP US Reason Data Type 9 Have any family members ever been diagnosed with Painful C Unknown Comment Bladder Syndrome PBS Interstitial Cystitis IC By Jim Dattilo 10 Have any family members ever been diagnosed with Chronic Pa CI Unknown Date 10 02 2009 12 21 02 Pain Syndrome CPPS Chronic Prostatis CP 11 Living with a spouse or partner 12 Research Coordinator ID 1010 M PENR Action mw v 4 Click on an item in the List to view the details Related Values opens a pop up window listing any previously entered values for the same CRF at different visits to show values over time In the example above the button is not available meaning this field has no related values History opens a pop up window listing the discrepancy history Discrepancy History Date Description Updated By Review Status Comment Resolution Reason SRE 10
60. p Full List of Links Bottom of the Screen Home Access to the Home Page within RDC Onsite Casebooks Access to the Casebooks Page and allow data entry within RDC Onsite Review Access to the Review Page within RDC Onsite Reports Access to the Reports Page within RDC Onsite Logout Logout of RDC Onsite The Home Page Session view will display the site and study last visited IMPORTANT For Security use the LOGOUT to securely end a given session Do not close or X out of a window and assume you have been successfully logged out of the application Preferences Change the way RDC Onsite displays data Preferences Cancel Apply Number of items to display News Activities and Links 20 Number of items to display all other lists except on Patient Casebooks page 15 Input Date Format mm dd yyyy US Display Date Format mm dd yyyy US v Display timestamps in local timezone Number of News items Activities and Links to display Specify the maximum number of items to be displayed in the News Activities and Links section of the Home Page If the number of items exceeds the maximum display limit specified here RDC Onsite will add NEXT and Previous links within the section boxes Number of items to display all other lists except on Patient Casebooks page Specify the maximum number of patients CRFs discrepancies and investigator comments to be displayed at a time on the Home Page and Review
61. point timestamp V1 0 20120318 Changes that are made to a CRF that have not yet been committed to the study database The changes that may be pending are response value investigator comments or discrepancies The save action commits pending changes to the database The ability for a user to perform a certain task Privileges are granted to users in the Administration study and site maintenance windows by administrators In general users within a user group that is those that are given the same role are assigned the same set of privileges The specific sequence that is employed at any time is defined by the Progression to next CRF setting in the Preferences window In PDF mode the browse sequence is invoked when you use the Previous and Next buttons A term that is a synonym for discrepancy A procedure that is run against a database with the goal of returning a subset of data that satisfies the query criteria A type of discrepancy action that causes the status to change from active to closed A parameter associated with a discrepancy action that provides a reason when a user closes a discrepancy The value that is assigned to a datapoint This term usually refers to the fields in the Question area of a CRF The order in which the system expects data to proceed from one field to the next Also termed Tab Order this is determined for each question during the CRF design of study setup It is utilized when you use the T
62. rences in data across time for patient safety e Complex discrepancies are triggered when a CRF is saved causing fields and icons to be flagged in red Example The system automatically calculates BMI from entered weight and height values if a weight value is missing the calculation cannot trigger Discrepancy Status There are two discrepancy statuses that operate with the RDC Onsite application Open Discrepancies and Closed Discrepancies Discrepancy Status CRF Icons Open Discrepancies appear in two formats Icon CRF Label Description e Active a discrepancy that requires action or There are no Other or Active resolution based upon data that has been entered No Meta na a CRF and validated These discrepancies produce red Discrepancies eaka Aiii icons and highlight the discrepant data in red CRF e Other a discrepancy that requires action or There is at least one Active resolution based upon data that has been reviewed I Active discrepancy in the CRF to be and queried by another user DCC Data Mangers addressed by you DM typically Other discrepancies also indicate There is at least one discrepancy that coding dictionary errors on entered data Adverse Other must be addressed by a user in a role Event AE Coding in Progress These discrepancies other than yours produce yellow icons and highlight the discrepant data in yellow Closed Discrepancies represent discrepancies that have been resolved e Res
63. s 1 50 0f 401 Next 50 gt Select All Select None Select G Patient Number Last Modified Casebook gt E 11000 Unassigned 11001 Unassigned 11002 Unassigned 11003 Unassigned 11004 Unassigned 11005 Unassigned 11006 Unassigned 11007 Unassigned 11008 Unassigned 11009 Unassigned 11010 Unassigned 11011 Unassigned 11012 Unassigned Internet Protected Mode On fa 100 Patient Search Displays a subset of patients Patient Search Range er S Assigned Book Any vi Show All v Discrepancy Status Al v Ciear li Go Range Search a range of patient numbers in terms of FROM and TO Click on the magnifying glass icon to select values from the patient identifier list and also to define a range Blank patient Range fields indicate that all patients should be displayed Only entering one number in either the FROM or TO will return only that patient number Assigned Book The name of the patient casebook IDX TEST etc Show View three possible sets or groups of patients All all patients are shown This is the Default view Patients with data entered select this view to review data already entered On the Home Page and Casebook Page selecting this option will eliminate patient rows from view for those patients who have no saved data Patients with no data entered select this view when initiating data entry for new patients This view will only show patients who have no data entered and are availabl
64. splays the following data in the columns Patient number for the query in this case there is one patient displayed on two rows Patient Number Visit Name amp Date Visit name and date of CRF entry V1 0 20120318 Oracle Clinical User s Manual Page 39 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 CRF Name CRF Name for the open discrepancies Question Section Hyperlink to open the Discrepancy Detail for more information Response Hyperlink to view the Discrepancy Details for more information Review Status Display the discrepancies current review status Description Display the discrepancy message Detail Open a review window to view related values and discrepancy history without opening the CRF Description Value of ONE for start time is not a valid TIME Reason DATA TYPE Comment Resolution Reason Resolution Comment Related Values Question Response Visit CRF Name Open CRF start time ONE BASELINE ELIG Bj History Date Review Status Comment Updated By 03 25 2011 11 26 51 Discrepancy not reviewed by user Maria Blanco Open CRF Hyperlink to a Data Entry Window DEW to address the discrepancy or modify data Sort the displayed discrepancies by clicking on any column header Discrepancies Refresh Patient Visit Number Name Date CRF Name Question Section Response Review Status Description Detail Open CRF PRE 10001 SCREEN 07 14 2009 PSCR MULT MULTI UNREVIEWED Please provide a respons
65. started entry status filter focus H 1 header field indicator question L list of values LOV M manual discrepancy V1 0 20120318 A method of data collection for studies that uses computers at investigator sites as a mechanism to submit patient data and information to a centralized study database Remote Data Capture RDC is an electronic data capture application An entry status that is assigned to a CRF in which all required fields have been entered including CRF header fields and Question area response datapoints An entry status that is assigned to a CRF in which data entry has been initiated but is not complete CRFs that are assigned this entry status some required data fields are complete while some are not the document has been saved in an incomplete status Formal stages of data entry delineated in RDC that track the progression of a CRF from no data entered created through entry complete A saved search that is applied to the Activity List window to limit the scope of the Navigation page and or the activities that are available in the Task pane It allows you to generate a more discrete and focused workset that is still based on an activity Where the cursor is currently active Focus may change from window to window as when the cursor moves from the Main Application window to the first data field in the Data Entry window when you click a CRF cell A location in the CRF header in whi
66. tedir rOnsSike isn a E RDC Onsite DE 100002 BASELINE DEMO Windows Internet Explorer provided by Co Sele j e http rt cceb upenn edu olsa oc rdcOpenHtmiCrf do vobj RdcMPCasebookCrfDetails O1 amp ppid 6891 76 158rdciid 19585 lt el ORACLE RDC Onsite Data Entry UUU Heed RDC Onsite DE 100003 BASELINE DEMO Windows Internet Explorer provided by Co E BR Highlic E http irt cceb upenn edu olsa oc rdcOpenHtmiCrF do vobj ORACLE RDC Onsite Data Entry RdcMPCasebookcrfDetails O1 amp ppid 689177 158rdciid O amp crfr Y In the example above the farthest window is the Casebook Surround Page the middle window is the Baseline DEMO form for patient 100002 and the closest window is the Baseline DEMO form for patient 100003 Opening a Data Entry Window DEW 1 Click on a CRF icon from either the Casebook Page or the Review Page Placeholder or Empty CRF The Casebook Spreadsheet is the only section of RDC Onsite that displays empty CRF icons These icons symbolize a CRF that is empty and awaiting ng data entry 2 Click an empty CRF icon in the Casebook Spreadsheet to open the pop up DEW and begin data entry Entered CRFs Entered CRFs contain data and can be accessed from either the Casebook Page or the Review Page and opened in a DEW to update data V1 0 20120318 Oracle Clinical User s Manual Page 24 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Patients Pr
67. the Casebook Spreadsheet Casebook Spreadsheet Set Visit Focus Patient Al Casebook IDXTEST v Patients 1 100f50 Next CRFs liofil Select Patients and Generate Patient Data Report w Add Select All Select None Patient VISIT 1 Select Number cG iv 11000 ob 1 11001 ob 1 2 Check the patient Select box to select a patient in the Casebook Spreadsheet Casebook Spreadsheet Set Visit Focus Patient Al Casebook IDXTEST v Visit VISIT1 v CRFs 1 lof1l w Patients 1 100f50 v Next Select Patients and Generate Patient Data Report w Add Visit Page Add Other Page Select All Select None VISIT 1 Select A Number Vv Click the Add Visit Page button in the control box section The Add Visit Page dialog box opens listing all the planned CRFs for the current visit patient study and site TIP Adding pages is not an option for IDX J RDC Onsite Add Visit Page Webpage Dialog http rt coeb upenn edu olsa oc rdcModalWindow do page CRFLovvVisit Add Visit Page Study VIP_HIP Wisit VISIT 4 Site VIP HIP 11 Patient 17000 CRFs Select CRF and Continue Select CRF Name E Cancel http rt cceb upenn edu olsa oc rdcModalWindow a Internet Oracle Clinical User s Manual V1 0 20120318 Page 33 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 4 Select a CRF by clicking on the radio button beside the CRF name 5 Click Continue to proceed to the next dial
68. to any even or CRF that was not part of the protocol schedule or which occurs at a time other than was originally specified in the protocol schedule A CRF collected at a visit at which it was not planned that is it is not part of the casebook A clinical event which occurs that was not scheduled by the protocol A process or condition in which CRF data or information which has previously been saved is changed A privilege that allows a user to initiate data entry update data initiate discrepancies and update discrepancies A database role that is granted to a user or user group There are five default user roles however any given study database may include some or all of these and may include protocol defined roles RDC allows privileges to be assigned independently of user role assignment An action that entails the initiation and processing of sponsor defined procedures in the case of multiple datapoints or edit checks in the case of a single datapoint that analyze collected data and return a query or discrepancy for each datapoint that does not meet the criteria defined in the procedure Such a data generated discrepancy is also referred to as a validation error A condition associated with one or more datapoints that indicates the value does not meet the criteria defined in a question definition or validation procedure It is equivalent to a data generated discrepancy When used in the context of criteria and parameters
69. tudy you are currently logged into will appear here The dropdown list allows you to select from the studies you have access to such as IDX Site The name of the Site currently logged into Ability to select sites from the dropdown menu is dependent upon your account s access permissions V1 0 20120318 Oracle Clinical User s Manual Page 5 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Password Management Steps to change Passwords after logging into RDC Onsite 1 Click Change Password in the upper right hand corner of the header of the RDC Onsite 4 6 Home Page 2 Enter the old password in the Old Password field 3 Enter the new password in the New Password field 4 Re enter the new password in the Confirm Password field 5 Click Apply to process the change Logout Prefere ces Change Password Hell Home f Casebooks Review Reports Logged in as Maria Blanco Data aa nt role OCTRIALP Last Refresh 07 19 4011 10 15 49 My and Site VIP_HIP v vier 11 Study and Site ummary News Patient Selection List No Records Found Patient Search Activities Review Investigator comments Patients Links Medication Reference Tool CRCU Select Patients ang Patient Casebooks v Go lt Previous 1 50 of 1000 x Next 50 Adverse Events Coding Tool NIH lt a Patient Number Last Modified Casebook 11000 07 07 2011 16 37 33 VIP HIP STUD
70. zes and displays information in pages oriented towards user tasks There are two main types of pages that make up RDC Onsite Surround Pages The Surround pages provide a way for you to review and interact with data Examples of the Surround pages include Home Page the Casebook Page the Review Page and the Reports Page All of which are accessible via the Tabs Data Entry Window DEW The Data Entry Window DEW displays a Case Report Form CRF that you can select and open from the Casebooks and Review Surround Pages V1 0 20120318 Oracle Clinical User s Manual Page 7 of 53 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Home Page in Review Tabs act as navigational tools presented in the upper left corner like file tabs and are also incorporated into the global links at the bottom of each page throughout the RDC Onsite application Home Casebooks Review Reports Home Home Page appears when logged into RDC Onsite and acts as the activity page providing News Items Actionable Items Snapshots and Search functionalities Casebooks Casebooks Tab allows access to the only page in RDC Onsite where data entry into a CRF can be initiated Review Review Tab access pages from which you can review general information about CRFs discrepancies and investigator comments these dialog boxes are available as sub tabs on the Review Page Reports Reports tab accesses the Reports Page where users with

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