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DREAM User`s Guide - University of Pennsylvania

1. Generate Blank Casebook Report This feature is not available for this study Blank case report forms are available on the DREAM landing page Review MedDRA Dictionary AE review the coded Adverse Event information for the selected patients This feature is not used for most studies Patient Selection List Patients Select Patients and Open Patient Casebooks Select All Select None Select Patient Number Last Modified Casebook E 31100 08 20 2014 17 41 16 DREAM CERT 31101 07 12 2014 20 50 DREAM CERT 31102 08 18 2014 12 26 DREAM CERT 31103 08 20 2014 17 36 1i DREAM CERT 31104 08 20 2014 12 42 1 DREAM CERT 31105 08 20 2014 17 56 DREAM CERT A bw A na 31106 08 20 2014 11 01 35 DREAM CERT 31107 Unassigned 31108 Unassigned 31109 Unassigned 31110 08 21 2014 12 16 DREAM CERT 31111 Unassigned V1 0 20140915 Oracle Clinical Users Manual Page 14 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Patient Icons 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 a eens White Patient data contains no open Patient data contains no open discrepancies Gray with a No data have been entered for this patient question mark Yellow Patient data includes discrepancies involving eligibility criteria which requires your attention Patient data includes di
2. Discrepancy All v Approval All Verification All v 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 L Placeholder No information has been entered ng Created The CRF contains header field information but no response data have been entered Entry Started The CRF contains header field information and at least some response data but has been saved incomplete Entry Complete All required CRF header and response data have been entered The CRF has been saved complete V1 0 20140915 Oracle Clinical User s Manual Page 18 of 60 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 Ee White Patient data contains no open discrepancies Patient data includes discrepancies involving eligibility criteria which requires your review Patient data includes discrepancies involving non eligibility criteria which requires your review Approval Status View CRF Approval Status for those CRFs that require Principal Investigator PI approval of some aspect of data collected on a given CRF or set of CRFs The Approval ICONS are icon Label Description urm e None The CRF has not been approved mrm Appr
3. Portable Document Format Principal Investigator Patient Identification Number Quality Assurance Quality Control Research Coordinator Oracle Clinical Remote Data Capture Serious Adverse Event School of Medicine UPENN University of Pennsylvania Oracle Clinical User s Manual Page 53 of 60 Oracle 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 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 data point A set of information that describes an instance of data update Each audit record includes the following information e the current value of the data point the previous value of the data point the username that changed the data point 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 w
4. epancies Study CVPF Site 308515 TIP Perform search to retrieve patient data Patient Range 4 A Assigned Book Any V CRF Status Entry Al vi Approval Al v Verification Al v CRF Source Casebook Al V visit Al V cRFName al V Discrepancy t Al v Discrepancies Patient Visit Number Name Date CRF Name Question Section Response Review Status Description Detail Open CRF No data found ebooks Review Reports Logout Preferences Change Password Heip 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 are 2 patients 2 CRFs and 6 total discrepancies Home Casebooks CRFs Discrepancies Investigator Comments Special Listings Home Logged in as Jim Dattilo Data management role OLSPRD Last Refresh 09 04 2014 13 23 43 Discrepancies Study DREAMCERT Site CRCUT1 1 Patients Selected 11 Total CRFs 18 Total Discrepancies 37 l Search Review 37 Active Discrepancies Patient Visit Number name Date E Name i Section edie Status Description 99100 SV OSI MULTI MULTI UNREVIEWED Review response for entry error f 3 ra a 99100 SV OSI MULTI MULTI UNREVIEWED Review response for entry error ical 99102 SV GI MULTI MULTI UNREVIEWED Response is required 99102 SV GI L MULTI UNREVIEWE
5. s Manual Page 50 of 60 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 Preferences Help Study CVPF Site 308545 Patient X1 Casebook CVPF Nyra Williams Data management role Previous CRF Next CRF pS ei ei i xl Highlight All Discrepancies Options are None Active Discrepancies Active and Other Discrepancies Closed Discrepancies All Discrepancies Investigator Comments Audit History etc RDC Onsite highlights the associated fields accordingly facilitating a quick review of the CRF 2 Navigate to the highlighted field 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 20140915 Oracle Clinical User s Manual Page 51 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Updating Discrepancy Validation 1 2 V1 0 20140915 Oracle Clinical User s Manual Page 52 of 60 If you have saved complete the Screening Visit Eligibility Review or the Request for Randomization and need to update discrepancies in preceding forms you may need to validate the record for the eligibility checks to be
6. 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 Entering an invalid date such as 04 31 2014 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 differences 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 or yellow Example selecting male as the gender and selecting yes to Is the patient a women of childbearing potential Discrepancy Status There are several a statuses that a with the RDC Onsite i White Patient data contains no open Patient data contains no open discrepancies Gray witha No data have been entered for this patient question mark Patient data includes discrepancies involving non eligibility criteria which requires your attention Yellow Patient data includes discrepancies involving eligibility criteria which requires
7. Mi ja 5 E 10 ob 15 ob 33 ob 40 45 E A 99101 Bj 5 10 ob 15 ob 38 ob 40 ob 45 Me pee E 5 10 15 38 ob 40 ob 45 m a 9913 ob 5 10 ob 15 nb ob 38 ob 40 ob 45 A a 9 ob 5 ob 10 J 15 nbl J 38 ob 40 ob 45 Bie 203 B 5 10 ab 15 ob 38 ob 40 ob 45 PM ob 5 ob 10 ob 15 ob 38 ob 40 ob 45 m a 907 5 10 Bj 15 Ej 38 E 40 45 mi ess ob 5 ob 10 ob 15 D gt gt gt ob 38 ob 40 ob 45 A Ge A A A A A A A Select a CRF by clicking the radio button next to the CRF name 4 5 Click Continue The dialog closes and returns to the Casebook Spreadsheet 6 Click the new CRF icon to open the icon in a DEW 7 Enter data and save the CRF V1 0 20140915 Oracle Clinical User s Manual Page 37 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 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
8. Test Expansion Start Date 3 Pre expansion CD3 CD45 TE Page 2 0384 C 4 Post expansion CD3 CD45 5 Total culture fold expansion This question is completed by the system when the form is data entered 6 Test Expansion C PASS O FAIL Open the CRF from the Casebook spreadsheet Check the CRF Blank box in the upper right corner of the CRF to make the selection The CRF will then be marked blank associated fields are grayed out and cannot be updated Changing the Status from Blank to Enterable To enter data in a CRF marked Blank 1 or Deselect the CRF Blank check box Deselect the Blank flag icon V1 0 20140915 Oracle Clinical Users Manual Page 35 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 If the Blank CRF was saved as Entry Complete and you either deselect the Mark this CRF as having no responses box or deselect the CRF Blank checkbox in the header you will be prompted to provide a Reason for Change V1 0 20140915 Oracle Clinical Users Manual Page 36 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Inserting Missed Visit or Telephone Visit CRFs There are two instances where you may need to insert a form onto a visit One form that may need to be added is a Missed Visit Form if a patient fails to have a study visit within the time window The Missed Visit Form must be inserted onto the visit that is actually missed The Telephone Visit Form TF may need to be inserted
9. 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 NOTE This Feature is NOT available in the study Sections provide information and a snapshot of actionable items No Records Found Review 5 Actve Discrepandes Review Investgator comments Links Medication Reference Tool CREU Adverse Events Coding Tool NIH Activities Provides customized tasks based on your role The tasks are displayed as hyperlinks Click the link Review 5 Active 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 20140915 Oracle Clinical User
10. cceb med upenn edu public dream_home html has a convenient link to the Oracle Clinical Remote Data Capture RDC system Be sure to bookmark this page as a favorite Data Management Utilities For Clinical Trials Data Entry Remote Data Capture Digital Retinal Image Submission Study specific data entry and data management are performed using Oracle Clinicals Remote Data Capture program an account please contact the DREAM Coordinating Center for your study Oracle Clinical Remote Data Capture Case Report Form Data Entry Logging In Clicking on the link Oracle Clinical Remote Data Capture Case Report Form Data Entry will access the Login Page of the RDC Enter your assigned User Name and Password and click Login The User Name and a temporary password are provided by the DREAM Coordinating Center During the first login you will receive a prompt to change your password If you forget your password you cannot log in to RDC Onsite To request a password reset you can contact crcuhelo mail med upenn edu User Name Password Login During certification logging in will allow access to the DREAMCERT database This is the database where the required exercise is entered After certification you will be given access to the live study database 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 addi
11. 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 Reason for Change Reason CRA Correction vi Comment optional Data Entry Error CRA Correction Inv consulted CRA Correction Src Data consulted Investigator Correction Study Assumption Thesaurus Clarification Analysis Correction Validation Status changed Data Entry Mode ale A 5 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 20140915 Oracle Clinical User s Manual Page 33 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Marking a CRF as Blank In very rare circumstances you may need to mark a CRF as intentionally blank When marking a CRF as blank all of the enterable data fields are grayed out and the data fields become inaccessible To mark a CRF as blank Use the Blank Flag icon in the DEW Toolbar 1 Op
12. entry error 3 Painful or sore eyes C E d E spam call Created By Jim Dattilo _ Review Status Discrepancy not reviewed by 4 Blurred vision C E EE E HLD Comment 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 V1 0 20140915 Oracle Clinical Users Manual Page 48 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 l Discrepancy History Date Description Updated By Review Status Comment Resolution Reason oe 08 21 2014 11 16 12 Review response Jim Dattilo Discrepancy not reviewed for entry error by user Help Close 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 20140915 Oracle Clinical User s Manual Page 49 of 60 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 Click a CRF icon to open it in the DEW Open the Discrepancy Navigator and select the specific d
13. onto a visit for a required call 1 month after the last study visit The Telephone Visit Form already exists on the 9 15 and 21 month visits To insert a MV or TF form 1 Select a visit from the Visit dropdown list 2 Check the Select box to select a patient in the Casebook Spreadsheet 3 Click the Add Other Page button in the control box The Add Other Page dialog opens listing all of the unplanned CRFs that can be added to the current visit for the selected patient The dialog also displays the study and site name ORACLE Roc onsite range Password Help 2 RDC Onsite Add Other Page Webpage Dialog Home Casebooks Review Reports Home gt ia https crcuedcl cceb med upenn edu olsa oc rdcModalWindow do page e ilo Data management role OLSPRD Last Refresh 09 04 2014 11 43 01 Add Other Page Study and Site DREAMCERT v CRCUTI 1 v d Study and Site Summary Pitient Casebooks Study DREAMCERT Site CRCU T1 1 Visit SV Patient 99100 Search 40 Patients Selected From Home Page CRFs Casebook Spreadsheet Select CRF and Set Visit Focus Patient Casebook DREAM CERT v Visit SV Select CRF Name xt G w p S Patients Previous 1 10of40 v Next amp CRFs Previous 4 19 0f 16 v Next TF Select Patients and Generate Patient Data Report v Add Visit Page Add Other Pag Select All Select None Patient Select Number GI oSI ODI E02 E03 cP
14. s Manual Page 9 of 60 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 Help Preferences 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 Not available in this study 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 Cancel Number of items to display News Activities and Links 20 Number of items to display all other lists except on Patient Casebooks page 15 V1 0 20140915 Input Date Format mm dd yyyy US v Display Date Format mm dd yyyy US v Display timestamps in local timezone p 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 n
15. topics V1 0 20140915 Oracle Clinical User s Manual Page 11 of 60 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 Patient Search Patients Select Patients and Open Patient Casebooks v Select All Select None D Select Patient Number Last Modified Casebook 31100 08 20 2014 17 41 16 DREAM CERT 31101 07 12 2014 20 50 19 DREAM CERT 31102 08 18 2014 12 26 02 DREAM CERT 31103 08 20 2014 17 36 18 DREAM CERT 31104 08 20 2014 12 42 12 DREAM CERT 31105 08 20 2014 17 56 12 DREAM CERT De Eb Pe P D En P p 31106 08 20 2014 11 01 35 DREAM CERT 31107 Unassigned 31108 Unassigned 31109 Unassigned 31110 08 21 2014 12 16 13 DREAM CERT 31111 Unassigned Patient Search Displays a subset of patients Patient Search Range Show All Discrepancy Status 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 Show View three
16. wish to comprise the work set A parameter may be comprised of settings that represent a value or range of values that when combined with V1 0 20140915 Oracle Clinical Users Manual Page 57 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 patient patient data patient list patient number pending changes privilege Q R query resolution resolution reason response value response sequence V1 0 20140915 any other parameters in the same criterion define specific data A 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 least 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 ata time 3 The first character in the patient number
17. your attention Open Discrepancies appear in two formats e Active a discrepancy that requires action or resolution based upon data that have been entered and validated These discrepancies produce red icons and highlight the discrepant data in red e Other a discrepancy that requires action or resolution based upon data that relates to eligibility criteria These discrepancies produce yellow icons and highlight the discrepant data in yellow V1 0 20140915 Oracle Clinical User s Manual Page 38 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Closed Discrepancies represent discrepancies that have been resolved e Resolution 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 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 casebo
18. 13 10 02 17 Investigator Comments Study CVPF Site 308515 sf TIP Perform search to retrieve patient data i Sem Patient Range Q Q Assigned Book Any V lt CRF Status Entry Al Discrepancy All Approval All W Verification All Vv CRF Source Casebook All Visit All VV CRFName All VY Investigator Comments Show Timestamps 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 Help About RDC 4 6 4 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 Dis
19. D At least one racial group must be checked 99102 SV GI MUL MULTI UNREVIEWED Response is required m EEEE E 99102 SV GI MUL MULTI UNREVIEWED Response is required m The Discrepancies 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 Visit name and date of CRF entry 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 V1 0 20140915 Oracle Clinical Users Manual Page 43 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Detail Open a review window to view related values and discrepancy history without opening the CRF Discrepancy Details Study DREAMCERT Site CRCU T1 1 Patient Number 99100 Description Review response for entry error Reason M EVENT 1 DCM Comment Resolution Reason Resolution Comment Related Values Question Response Visit CRF Name Open CRF Poor vision SV OSI History Date Review Status Comment Updated By 08 21 2014 11 16 12 Discrepancy not reviewed by user Jim Dattilo dose Open CRF Hyperlink to a Data Entry Window DEW to address the discrepancy or modify data Sort the displayed discrepa
20. EBOOK SPREADSHEET OVERVIEW CASEBOOK SPREADSHEET CONTROLS 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 MARKING A CRF AS BLANK INSERTING MISSED VISIT OR TELEPHONE VISIT 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 UPDATING DISCREPANCY VALIDATION LIST OF ABBREVIATIONS GLOSSARY V1 0 20140915 Oracle Clinical Users Manual Page 2 of 60 O COON NN OO UO BW W m e N N WU UVU UVUUVNNNNNNNNN FE N BNP O ON OU HWWHDN NI Ww 0e U UAA BBW WW W NON NN FP O WO CO 0 uw ju e W 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 7 Internet Explorer IE 6 or higher Adobe Acrobat Reader or Professional 7 or above If Adobe is not installed it can be downloaded from the Adobe website http Wwww adobe com Follow the
21. Oracle Clinical Remote Data Capture RDC Onsite 4 6 DREA Oracle Clinical Remote Data Capture RDC Onsite 4 6 User s Manual v1 0 20140915 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 Res areh 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 20140915 Oracle Clinical Users Manual Page 1 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Table of Contents SYSTEM REQUIREMENTS PERSONAL COMPUTER PC REQUIREMENTS COMPATIBILITY VIEW STUDY LANDING PAGE 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 GENERAL DATA ENTRY INSTRUCTIONS CASEBOOK PAGE DATA ENTRY HOME PAGE SELECTION AND CASEBOOK DATA ENTRY CAS
22. RF 99100 SV OSI MULTI MULTI UNREVIEWED Review response for entry error Ej Ej 99100 SV OSI MULTI MULTI UNREVIEWED Review response for entry error E E 99102 SV GI MULTI MULTI UNREVIEWED Response is required E Ej 99102 SV GI MULTI MULTI UNREVIEWED At least one racial group must be checked E E 99102 SV GI MULTI MULTI UNREVIEWED Response is required A E 99102 SV GI MULTI MULTI UNREVIEWED Response is required E E In the case above 2 Patients 2 CRFs and 6 Total Discrepancies V1 0 20140915 Oracle Clinical Users Manual Page 41 of 60 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 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 4 current patients with data Study DREAMCERT Site CRCUT1 1 Patients Selected 27 Total CRFs 280 Search Patient CRFs Select CRFs and Verify v El Show Timestamps Previous 1 1000f280 v Next100 Select All Select None Patient Visit Date Open Select Number Name Date CRF Name Casebook Modified Verified Approved Locked CRF a 99100 SV cP DREAM CERT 07 14 2014 99100 S
23. Select None Patient Number 99100 ODI TH ob 15 Z 20 Bj 25 ab 15 ob 20 ob 25 ob 15 ob 20 ob 25 ob 15 ob 20 ob 25 ob 15 Bj 20 E 25 d 15 ob 20 b 25 B z ob 20 20 Select Patients and Generate Patient Data Report Go Add Visit Page Add Other Page F i E Q wi 99101 w 99102 wi 99103 wi 99104 uw 99105 99106 wi GOO 99107 e Aig lA T A mle TA 1 1 amp nl wi 99108 Ep F A 99109 w The above view shows Discrepancies There is a CRF ICON 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 are CRF ICONSs 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 CRF ICONSs displayed in the list above for available patient identification numbers There has been no data entered or saved for these CREs V1 0 20140915 Oracle Clinical User s Manual Page 21 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Home Page Selection and Casebook data entry F
24. Users Manual Page 59 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 value visit V1 0 20140915 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 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 Users Manual Page 60 of 60
25. V GI DREAM CERT 08 19 2014 99100 SV MH DREAM CERT 07 24 2014 Z 99100 SV OSI DREAM CERT 08 21 2014 E F 99100 SV TH DREAM CERT 08 18 2014 Z F 99100 00 DS DREAM CERT 07 24 2014 F 99100 00 OSI DREAM CERT 08 06 2014 99100 AELOG AE DREAM CERT 06 06 2014 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 Date is blank since it is not used for the DREAM study CRF Name CRFs listed according to the order within a Casebook in this case there several CRFs 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 20140915 Oracle Clinical User s Manual Page 42 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Home Casebooks Review Reports ao ee CRFs f Discrepancies f investigator Comments Special Listings Discrepancies Access to Search Discrepancies D e ad E AG Logout Preferences Change Password Help me Casebooks Review Reports Fs Discrepancies Investigator Comments Special Listings Logged in as Nyra Williams Data management role OCTRIALP Last Refresh 10 30 2013 09 32 32
26. a 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 CRF Date Year Selection Month Selection Increase Decrease Drop Down Box MONS Previous Month a Arrow __ October 2009 gt lt Next Month Arrow SUN MON TUE WED THU FRI SAT 72 3 4 5 6 7 8 9 1 Today s date Ei 12 13 14 15 16 ema tee 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 20140915 Oracle Clinical User s Manual Page 29 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 List of Values V1 0 20140915 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 Accept
27. able List Of Values Select Display Seq Value Description O 1 1 Every day 2 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 Oracle Clinical User s Manual Page 30 of 60 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 2 Enter the data 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 Save Complete 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 respons
28. ata Report v Number GI oSI Go MH TH E01 E02 E H S H B B B H E E E V1 0 20140915 Oracle Clinical User s Manual E03 55 u2 E EE EE Page 40 of 60 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 ep JAN al ME EG Home Casebooks Review Reports News No Records Found Patient Selection List Patient Search Patients act Patients and ation Reference Tool CRCU Select All Jone Adverse EV coding Tool NIH Ep BD Be E gt Ep oooofoooook Select Patients and 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 CRFs Discrepancies Investigator Comments Special Listings Home gt Logged in as Jim Dattilo Data management role OLSPRD Last Refresh 09 04 2014 13 23 43 Discrepancies Study DREAMCERT Site CRCUTI 1 Patients Selected 11 Total CRFs 18 Total Discrepancies 37 Search E m Review 37 Active Discrepancies Patient _ _ Visit Number Name Date ICRF Name Question Section Response Review Status Description Detail Open C
29. crepancies Patients 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 Patient Search Patients Select Patients and Open Patient Casebooks hd Select All Select None Select Patient Number Last Modified Casebook 31100 08 20 2014 17 41 16 DREAM CERT 31101 07 12 2014 20 50 19 DREAM CERT 31102 08 18 2014 12 26 02 DREAM CERT 31103 08 20 2014 17 36 18 DREAM CERT 31104 08 20 2014 12 42 12 DREAM CERT 31105 08 20 2014 17 56 12 DREAM CERT A i A i ii 0 i 31106 08 20 2014 11 01 3 DREAM CERT 31107 Unassigned 31108 Unassigned 31109 Unassigned 31110 08 21 2014 12 16 13 DREAM CERT 31111 Unassigned Select Select patient by checking the box in the first column 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 V1 0 20140915 Oracle Clinical User s Manual Page 13 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Review Entered CRFs review entered CRFs for the selected patients Review Investigator Comments review investigator comments for the selected patients Generate Patient Data Report This feature is not available in this study
30. en a CRF from the Casebook Spreadsheet 3 2 Select the Blank Flag icon from the DEW toolbar A CRF Blank Selection s processing dialog appears with these choices example below Mark this CRF as having no responses Mark the Section Name Number as having no responses this pertains to CRFs with multiple sections for example extensive Medical History CRF Blank Selection s Processing 34 O Wark this CRF as having no responses hark section VITSLS 1 as having no responses Help Cancel OK 3 Check the box to make the selection typically Mark this CRF as having no responses 4 Select OK The CRF will be marked blank associated fields are grayed out and cannot be updated V1 0 20140915 Oracle Clinical User s Manual Page 34 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Using the Blank Flag Checkbox in the CRF Depending upon the design of the CRFs approved for the study a CRF Blank checkbox will appear in the header of the CRF RDC Onsite DE X1 SCREENING EXD T Windows Internet Explorer ORACLE RDC Onsite Data Entry Study CVPF Site 308515 Patient X1 Casebook CVPF Nyra Williams Data management role Previous CRF Next CRF aS lank G Participant ID X1 Participant Initials XYZ Site XDUMMY1 Data Entry Date TEST EXPANSION FROM DONOR BLOOD COLLECTION TE Page 1 0384 C 1 Test Expansion Number Wa B2 3 TE Page 1 0384 C 2
31. es 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 have 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 20140915 Oracle Clinical User s Manual Page 31 of 60 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 The Previous CRF or Next CRF opens in the same DEW and will move you backward or forward through
32. ge Surround the Casebook Page Surround or the Review Page Surround as detailed in the previous sections e Use the Navigator Pane to review in list format all Discrepancies or Investigator Comments if applicable for the study for a CRF e By navigating through the list of Discrepancies or Investigator Comments you simultaneously navigate through the associated fields in the CRF Discrepancy Investigator Comment Show All Discrepancies v oSI 1 2 gt zA l l List DREAM ID No 99100 Alpha Code ABCD Visit SV wut Re Ene te Hh Muti OCULAR SURFACE DISEASE INDEX Please answer the following questions by checking the box that best represents your answer Have you experienced any of the following during the last week eee eee All of the Most of the Half of the Some of the None of the P E eee time time time time time a 1 Eyes that are sensitive to light E E EE a Details Related Values History 2 Eyes that feel gritty E E O T gescription Review response for entry Ce e P aes Type MUL PV ReA 3 Painful or sore eyes zx EE El m0 ARE E Created By Jim Dattilo Cee E Review Status Discrepancy not reviewed by 4 Blurred vision C E E T user Comment 5 Poor vision Tt i Tt it it Last Updated 08 21 2014 11 16 12 Using the Navigator Pane 1 Click the arrow on the right edge of the DEW to open close the Navigator Pane 2 Select a tab either Discrepancy Navigator or Investigator Comments Naviga
33. he 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 for 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 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 N O news item 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 open 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 least one active or other discrepancy P parameter A component of a criterion that you use to define a specific property of the data you
34. he 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 have been deemed acceptable by the PI protocol or study sponsor A designation attributed to any event 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 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 data points or edit checks in the case of a single data point that analyze collected data and return a query or discrepancy for each data point 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 data points that indicate the value Oracle Clinical
35. here 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 which you collect values that provides information about the CRF All required header fields must be collected before the system permits a CRF to be saved to the study database Oracle Clinical Users Manual Page 56 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 indicator question A question used with certain question groups that allow 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 Ifthe 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 L list of values LOV 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 M manual discrepancy 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 MedDRA T
36. indow 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 record 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 data point 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 Abridged version of the Glossary from the RDC User Guide V1 0 20140915 Oracle Clinical Users Manual Page 54 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Clinical Research Computing Unit CRCU closed CRF header current current study D data entry mode data entry status data field data point data update discrepancy V1 0 20140915 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 develo
37. installation instructions provided on the Adobe website If the Internet browser s popup blocker is enabled make sure to allow popups from the following websites https crcuedc1 cceb med upenn edu Disable Yahoo Search Google Toolbar AOL Toolbar Windows Messenger add ons 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 20140915 Oracle Clinical User s Manual Page 3 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Compatibility View If you open a case report form in the RDC and the form appears as a blank page you will need to change the compatibility view in Internet Explorer To turn on compatibility view go to the Tools Menu and choose Compatibility View settings Make sure the Display all websites in Compatibility View is checked Click on Close g Compatibility View Settings Lal You can add and remove websites to be displayed in oy Compatibility View Add this website Websites you ve added to Compatibility View Remove Indude updated website lists from Microsoft Display intranet sites in Compatibility View Display all websites in Compatibility View V1 0 20140915 Oracle Clinical Users Manual Page 4 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Study Landing Page The study landing page at http rt5
38. isabled in the last CRF in a visit for a patient x 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 user s assigned role V1 0 20140915 Oracle Clinical Users Manual Page 27 of 60 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 Horizontal Scrollbar Page Navigation V1 0 20140915 Right of the open window if the CRF is too long to fit within the open DEW Bottom of the open window if the CRF is too wide to fit within the open DEW 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 Ep Page 12 Ek G First Page Previous Next Last Page Oracle Clinical User s Manual Page 28 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 General Data Entry with a Data Entry Window DEW Using the Keyboard Tab Move the cursor to the next dat
39. iscrepancy Select Closed no resolution from the Action dropdown list at the bottom of the Discrepancy Navigator and then click Go e The Discrepancy Action dialogue bax opens see example below e pe wz T e ae 3 e List DREAM a Pees erie ee le Muti OCU Please answer the following quest Review Status IRRESOLVABLE Comment Have you experienced any of the follo optional 1 Eyes that are sensitive to light Resolution n Details Related Values History 2 Eyes that feel gritty Resolution Description Review response for entry Comment error 3 Painful or sore eyes ype See Created By Jim Dattilo e r e Remember comment for subsequent Discrepancy resolution o Review Status Discrepancy not reviewed by 4 Blurred vision lee user Po Comment 5 Poor vision Last Updated 08 21 2014 11 16 12 e e e e e Have problems with your eyes limited you in performing any of the following sudna the last week J All ofthe Most ofthe Halfofthe Somesofthe None ofthe Not gt time time time tie time applicable e 6 Reading L C Ci e C Action Closed no resolution v Go Y e Supply a Resolution Reason and add a Resolution Comment Click OK 5 Poor vision The field highlight will switch from red to green and the Navigator Pane will display the Review Status as Irresolvable Save the CRF for the changes to take effect V1 0 20140915 Oracle Clinical User
40. 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 7 DEO re cee une eciiiolsatorcirocOn Site isn RDC Onsite DE 100002 BASELINE DEMO Windows Internet Explorer provided by Co 0X y http f rt cceb upenn edu olsa oc rdcOpenHtmicrF do vobj RdcMPCasebookCrfDetails O1 amp ppid 689176158rdciid 19585 Y ORACLE RDC Onsite Data Entry File tudy F4 RDC Onsite DE 100003 BASELINE DEMO Windows Internet Explorer provided by Co m Bf BZ i Highlig e http j irt cceb upenn edujolsajoc rdcOpenktmlCrf do vobj RdcMPCasebookCrfDetails YO 1 amp ppid 689177158rdciid 08crfr Y ORACLE RDC Onsite Data Entry 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 V1 0 20140915 Oracle Clinical User s Manual Page 25 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 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
41. ncies by clicking on any column header Review 37 Active Discrepancies Patient Visit Number Name Date Response Review Status Description 99103 00 BY Sphere Sign UNREVIEWED Value of for Sphere Sign not found in 1 2 99103 00 BV Cylinder Sign UNREVIEW Value of for Cylinder Sign not found in 1 2 99103 00 BV Sphere Sign UNREVIEW Value of for Sphere Sign not found in 1 2 99103 00 V Cylinder Sign UNREVIEW Value of for Cylinder Sign not found in 1 2 SV Fluorescein staining Grade UNREVIEWED Value of 4 for Fluorescein staining Grade not found in 0 1 2 3 Sort or Search by o Patient to view a list of all discrepancies sorted by patient o Visit to 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 Casebooks 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 V1 0 20140915 Oracle Clinical Users Manual Page 44 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 lt ORACLE RDC Onsite Home Casebooks Review Reports CRFs Discrepandes Investigator Comments Special Listings Logged in as Nyra Williams Data management role OCTRIALP Last Refresh 10 30 20
42. ns 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 located in the top section Casebook Spreadsheet Set Visit Focus Patient Casebook DREAM CERT v Visit Patients Previous 1 40f4 w Next amp The controls from left to right are Patients Casebook View Visit CRFs V1 0 20140915 SV CRFs Previous 1 100f 15 v Next 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 is the default Casebook or study a user is currently working in allows the user to select a visit from the dropdown list to view the CRFs associated with the Visit 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 Oracle Clinical User s Manual Page 23 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Navigating within the Casebook Spreadsheet Visit Name CRF Names Patient Select B Number a 920 5 E 10 nb 15 20 Bj 25 nb 30 nb 35 up 38 nb 40 45 CRFs The information lis
43. ok order This organization can be useful in managing discrepancies on a patient by patient or visit by visit basis Logged in as Jim Dattilo Data management role OLSPRD Last Refresh 09 04 2014 13 18 51 Study and Site DREAMCERT v CRCU T1 1 v Study and Site Summary Patient Casebooks TIP Perform search to retrieve patient data Patient Range oS A Assigned Book Any Show All CRF Status Entry All v Discrepancy All v Approval All CRF Source Casebook All v Visit All v CRFName All v Casebook Spreadsheet Set Visit Focus Patient Patients Patient Select 3 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 Patient Range 4 4 Assigned Book Any w A CRF Status Entry All Y Discrel mncy Al Appro 2 v Verification All CRF Source Casebook All Y Visit Al CRI Active Other Open Active amp Other iClean None or Closed 3 Click Go The Casebook Spreadsheet will display only those CRF icons with active discrepancies V1 0 20140915 Oracle Clinical User s Manual Page 39 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Patient 99100 E i0 99101 Z z 99102 E 5 99103 D Pe fh hP prop ERNE Eo 99104 99105 Z 5 99106 A 99107 99109 99110 Select Patients and Generate Patient D
44. omfort you can imagine Please rate your ocular discomfort by circling the one number that tells how much ocular discomfort you have right now Oa O Ce De De O82 Ce CF OF Ce Cle n A Copyright 2000 2007 Oracle All rights reserved V1 0 20140915 Oracle Clinical Users Manual Page 26 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Data Entry Window DEW toolbar DEWs have a standard toolbar to facilitate work within the CRF ORACLE RDC Onsite Data Entry Pre ores Study CVPF Site 308515 Patient X1 Casebook CVPF Nyra Williams Data management role Previous CRF Next CRF Pomon arosa V BG OO amp A The DEW toolbar icons are described below Add Discrepancy The Add Discrepancy window opens iE Investigator The Add Update Investigator Comment window opens Comment Delete Row The Delete Row dialog opens Brank Fiag Toot Bian Fag Toot Tool The CRF Blank Selecton s Processing dialog opens CRF Blank Selection s The CRF Blank Selecton s Processing dialog opens dialog opens The Verify CRF window opens Eon pams ES approva istory History The Tne Approve CRE window opens CRF window opens ce ee to the previous CRF This link appears only if a CRF is opened from the Casebooks Page The link is disabled in the first CRF in a visit for a patient Previous CRF Navigate to the next CRF This link appears only if a CRF is opened from the Casebooks Page The link is d
45. on where you can initiate data entry for a CRF Casebook Page Data Entry 1 Casebooks Review Click on the Casebooks tab to open the study Patient Casebooks Search and Casebook Spreadsheet display view ap AN eel El See elede Logout Preferences Change Password Help Home Casebooks Review Reports Logged in as Nyra Williams Data management role OCTRIALP Last Refresh 10 29 2013 14 38 Study and Site CVPF Vv 308515 V Study and Site Summary Patient Casebooks About RDC 4 6 4 2 Search Patient CRF Status CRF Source TIP Perform search to retrieve patient data Search o Patient Range Qu Q Assigned Book Any V Show All CRF Status Entry All Discrepancy All Approval All Verification All w CRF Source Casebook All visit All CRFName All WV Go Casebook Spreadsheet Set Visit Focus Patient ad Casebook M Visit w Patients Previous Y Next CRFs Previous Y Next G Patient Select amp Numbe Home Casebooks Review Reports Logout Preferences Change Password Help Copyright 2000 2007 Oracle All rights reserv To view patients data in the Casebook Spreadsheet either enter search parameters or click on Go in the Search section of the Casebook Page Range 4 S Assigned Book An
46. oved The CRF has been approved At least one data point in the approved CRF has been modified since approval The CRF must be re approved aS Re approval ow om Required TIP This study 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 the Coordinating Center Study Monitor verification of some aspect of data collected on a given CRF or set of CRFs The Verification Status ICONS are Icon Label Description errs s None The CRF has not been verified o Verified The CRF has been verified At least one data point in the verified av Re verification CRF has been modified since mA Required verification The CRF must be re verified TIP This study 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 20140915 Oracle Clinical User s Manual Page 19 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 CRF Source Casebook Al g 7 Visit E i CRF Name Al w The Search options for the CRF Sou
47. play 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 20140915 Oracle Clinical User s Manual Page 45 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Special Listings View specialized questions Examples may include Adverse Events or Concomitant Medications with coding errors that need to be reviewed and updated Oracle Pharmaceutical Applications Remote Data Capture OnSite Penn Charvarsrry Of TRUBS TELTAN 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 TIP Perform search to retrieve patient data Patient Q Listing Type v Refresh 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 20140915 Oracle Clinical Users Manual Page 46 of 60 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 Pa
48. pment 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 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 curren
49. 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 V1 0 20140915 Oracle Clinical User s Manual Page 12 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 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 Discrepancy Status View patients with discrepancies From the Home Page view the results appear as patient 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 eligibility discrepancies during the screening and baseline visits Open Active amp Other display open discrepancies that are active and other Clean None or Closed retrieve patients with no open active or other dis
50. r 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 CRF s the number of CRFs that have been allotted or planned per visit per patient Unplanned CRF s represents the number of CRFs that were entered as unplanned forms per the existing study matrix missed visit or telephone visit 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 eligibility criteria With no Open Discrepancies represents the number of CRFs without any currently open discrepancies V1 0 20140915 Oracle Clinical User s Manual Page 16 of 60 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 applicati
51. rce row Casebook will allow users to specify ALL or the study to which they are currently logged in to From the above users can select Casebook DREAM CERT v Visit 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 AE LOG SAE INT SAE FU IMED LOG PRN CRF Name 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 CRF Name All Y TIP When logged into the study users will be presented with a specific list of study CRFs V1 0 20140915 Oracle Clinical User s Manual Page 20 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Patient Range Q assigned Book Any w Show AI K CRF Status Entry All v Discrepancy All J Approval An V Verification All v CRF Source Casebook All Visit All v CRF Name Al w 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 Casebook DREAM CERT v Visit SV Patients 1 10 0f 40 v Next fv 1 100f 16 v Next G Select Patients and Generate Patient Data Report v Add Visit Page Add Other Page Select All
52. rom the Home Page you can select a set of patients from the Patient Snapshot or Patient Selection List section Patient Selection List Pa i i Patients Select Patients and Open Patient Casebooks v Select All Select None Select Patient Number Last Modified Casebook 99100 08 21 2014 11 16 13 DREAM CERT 99101 07 24 2014 10 56 07 DREAM CERT 99102 09 02 2014 12 31 17 DREAM CERT 99103 08 08 2014 10 16 57 DREAM CERT 99104 07 24 2014 10 56 07 DREAM CERT 99105 08 18 2014 11 26 02 DREAM CERT 99106 08 27 2014 08 31 18 DREAM CERT 99107 08 27 2014 08 31 18 DREAM CERT 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 3 Click on the Go button to be taken to the Casebook spreadsheet for the selected patients AN Ge Ml ALEG Logout Preferences Change Password Help Home Casebooks Review Logged in as Jim Dattilo Data management role OLSPRD Last Refresh 09 03 2014 11 58 10 Study and Site DREAMCERT v CRCUT1 1 Study and Site Summary Patient Casebooks Casebook Spreadsheet Set Visit Focus Patient Casebook DREAM CERT v Visit SV Patients Previous 1 10of40 w Next Previous 1 39 0f 16 v Next G Select Patients and Generate Patient Data Repo
53. rt v Add Visit Page Add Other Page Select All Select None Patient SV Select Number I OSI DI MH MM G o TH cP Hg 2w 5 E 10 ob 15 20 Bj 25 ob 30 2 a 99101 B 10 ab 15 20 ob 25 ob 30 op a3 a 7102 E 5 10 15 ob 20 ob 25 ob 30 b P a amp 99103 D 5 10 j 15 ob 20 ob 25 ob 30 ob ia 99104 ob 5 ob 10 ob 15 ob 20 ob 25 30 ob 45 V1 0 20140915 Oracle Clinical User s Manual Page 22 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Casebook Spreadsheet overview ORACLE RDC Onsite Home Casebooks Review Reports Home gt Patient Casebooks Search 4 Patients Sel Casebook Spreadsheet Set Visit Focus Patient Casebook DREAM CERT v Patients Previous 1 40f4 v Next amp Select Patients and Generate Patient Data Report v Select All Select None Patient Select Number 99 100 F 99101 ra 99102 99103 Visit SV Go Add Visit Page Add Other Page Logout Preferences Change Password Help Logged in as Jim Dattilo Data management role OLSPRD Last Refresh 09 04 2014 09 58 04 Study and Site DREAMCERT Y CRCUT1 i v Study and Site Summary vious 1 10of15 v Next ODI Fi Ji F ae MH Bj 20 ab 20 ob 20 ob 20 TH ee ob 25 ob 25 ob 25 cP 7 Fi Fi Ji e Casebook Spreadsheets displays patients in rows and the expected study related CRFs in colum
54. screpancies involving non eligibility criteria which requires your attention Patient Number The patient number or patient identification number PID is an assigned unique number for each patient unique to a given site Last Modified The value in this field represents the date and time of the last modification to the patient s entered data A modification can represent any of the following actions data updates discrepancy resolution or initial entry of a CRF Casebook Name The casebook name is the name of the casebook or CRF packet to which a given PID has been assigned 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 Jim Dattilo Data management role OCTRIALP Last Refresh 08 22 2014 11 33 06 Study and Site DREAMCERT v DREAM 31 1 v Study and Site Summary 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
55. sfactorily 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 none closed active other saan he 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 data points 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 is available in the Task pane It allows you to generate a more discrete and focused work set that is still based on an activity W
56. snapshot of data related to Study Summary provides number of sites number of patients with data number of CRFs and number of discrepancies Site Summary provides the name of the Investigator address of the Investigator patient summary information number of CRFs with discrepancies and number of discrepancy free CRFs V1 0 20140915 Oracle Clinical User s Manual Page 15 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Study and Site Summary Study Summary Dry Eye Assessment and Management Study Study Information Study CRF Information Total Sites Planned Not Verified Patients Created Unplanned Awaiting Re Verification 2 Patients Enrolled Total Verified O0 Patients With Data Locked 0 NotLocked 361 With Active Discrepancies NotApproved 361 With Other Discrepancies Awaiting Re Approval O With no Open Discrepancies Approved 0O Site Summary CRCU T1 1 Site Information Site Patient Information Investigator Dr Maureen Maguire Patients Created 40 Investigator Address Philadelphia PA USA Patients Enrolled 0 Patients With Data 25 Site CRF Information Planned 256 Not Verified With Active Discrepancies NotApproved 271 Unplanned 15 Awaiting Re Verification 1 With Other Discrepancies Awaiting Re Approval 0 Verified O0 With no Open Discrepancies Approved 0O Locked O NotLocked 271 NoteThis report may include counts of CRFs and discrepancies that you do not have the required access to view depending upon your use
57. string may be a non zero numeric or an alphabetic character 4 Ifthe 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 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 data point This term usually refers to the fields in the Question area of a CRF The order in which the s
58. t 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 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 Oracle Clinical Users Manual Page 55 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 discrepancy management discrepancy record discrepancy status E F electronic data capture EDC entry complete entry started entry status filter focus H 1 header field V1 0 20140915 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 sati
59. te 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 5 3 Home Page Enter the old password in the Old Password field Enter the new password in the New Password field 2 3 4 Re enter the new password in the Confirm Password field 5 Click Apply to process the change Logout Preference Change Password He Ps Management role OCTRIALP Last Refresh 1 29 2013 14 03 21 Study and Site CVPF Select Site V S tug and Site Summary Logged in as Nyra Willig Patient Selection List Patient Search ORACLE Roc onsite Home Casebooks Review Reports Home gt Change Password few Repos Ligi Preferences Change Password Hep V1 0 20140915 Oracle Clinical Users Manual Page 7 of 60 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 Global Links e Session Information Logged in as Jim Dattilo Data pears oc OcA Last Zefe os zat Session Study and Site Summary E Information Patient Selection List 21_Batinet Search Patient sth aoe Pa
60. ted in the control section of the Casebook Spreadsheet corresponds to the spreadsheet view Visit Name displays the current Visit Name In the above example SV is displayed CRF Names the CRFs associated with the Visit are displayed under the 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 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 20140915 Oracle Clinical User s Manual Page 24 of 60 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
61. 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 V1 0 20140915 Oracle Clinical User s Manual Page 32 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Reason for Change Reason fits Comment optional Help Cancel OK The Reason for Change is used as a way to provide additional information regarding
62. 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 Set Visit Focus Patient Casebook DREAM CERT Visit SV v Patients ry 1 40f4 v CRFs f 1 10of15 v Next Select Patients and Generate Patient Data Report v Add Visit Page Add Other Page Select All Select None Patient Select i Number GI A 99100 5 A 99101 E 5 A 99102 Ey 5 His 99103 of 5 ORACLE RDC Onsite Data Entry Study DREAMCERT Site CRCU T1 1 Patient 99100 Casebook DREAM CERT Jim Dattilo Data management role Highlight All Discrepancies y Fe Ff EY i amp A es DREAM wv so paco asco 01 24 2014 Page 1 of 2 Brief Ocular Discomfort Inventory BODIO Please rate your ocular discomfort by circling the one number that best describes your ocular discomfort at its worst in the last week Cie Ce Ee OS be Es Ose bet BS Os OS No Discomfort as bad as Discomfort you can imagine Please rate your ocular discomfort by circling the one number that best describes your ocular discomfort at its least in the last week te fle Ee OS be Es Os OF Ee Os Os No Discomfort as bad as Discomfort you can imagine Please rate your ocular discomfort by circling the one number that best describes your ocular discomfort on the average in the last week 0 O 0S Oe De 0e Oe O7 Oe Ose Oe No Discomfort as bad as Disc
63. tients Search Sections Review Investigator comments Select Patients and Open Patient Casebooks v Tool lt gt Select All Select None Select Patient Number Last Modified Casebook E 31100 08 20 2014 17 41 16 DREAM CERT I A 31101 07 12 2014 20 50 19 DREAM CERT T e 31102 08 18 2014 12 26 02 DREAM CERT A 31103 08 20 2014 17 36 18 DREAM CERT a 31104 08 20 2014 12 42 12 DREAM CERT 118 31105 08 20 2014 17 56 12 DREAM CERT Patient al amp 31106 08 20 2014 11 01 35 DREAM CERT Snapshot 7 31107 Unassigned 31108 Unassigned 31109 Unassigned 31110 08 21 2014 12 16 13 DREAM CERT 31111 Unassigned 31112 Unassigned 31113 Unassigned 31114 Unassigned 31115 Unassigned 31116 Unassigned 31117 Unassigned 31118 Unassigned 31119 Unassigned 31120 Unassigned RDC Onsite organizes 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 20140915 Oracle Clinical User s Manual Page 8 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Home Page in Review Tabs act
64. tions or modifications within the Oracle Clinical system and can be tracked through the Audit Trail V1 0 20140915 Oracle Clinical Users Manual Page 5 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Data Management System DMS 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 Jim Dattilo Data management role OCTRIALP Last Refresh 08 22 2014 11 33 06 Username Role Database Last Refreshed Study Site V1 0 20140915 Study and Site DREAMCERT ha DREAM 31 1 v Study Site Your first and last name Role corresponds to your username Different roles have different levels of access and privileges within the RDC Onsite application Displays the name of the database to which you are currently logged into 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 The name of the Study you are currently logged into will appear here The dropdown list allows you to select from the studies you have access to The name of the Site currently logged into Ability to select sites from the dropdown menu is dependent upon your account s access permissions Oracle Clinical User s Manual Page 6 of 60 Oracle Clinical Remo
65. tor There are two sub panes of the Navigator List and Details These sub panes help organize information and facilitate movement in the open CRF 3 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 20140915 Oracle Clinical User s Manual Page 47 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Discrepancy Investigator Comment Show All Discrepancies 0 1 gt A i Zip Code Action v Discrepancy Investigator Comment Show All Discrepancies w Sn 12 OG A DREAM DREAM ID No 99100 Alpha Code ABCD Visit SV Muti Muti OCULAR SURFACE DISEASE INDEX Please answer the following questions by checking the box that best represents your answer m Have you experienced any of the following during the last week All of the Most of the Half of the Some of the None ihe time time time time e 1 Eyes that are sensitive to light C a E E Details Related Values History 2 Eyes that feel gritty E O O T Description Review response for
66. umber 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 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 time zone 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 Oracle Clinical User s Manual Page 10 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 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
67. updated To validate the record check the box under the select column and select Validate Select Patients and 2 Add Other Page Select All Select None Patient Select 4 Number GI OSI ODI A sole 5 10 nb 15 After clicking on Go you will receive a warning message Click on Continue ak Warming You have requested validation for 1 patients This may take several moments to execute Do you wish to continue 3 RDC Onsite Validate Patients Webpage Dialog A https rt9 cceb med upenn edu olsa oc rdcModalWindow do page validate Validation successful Oracle Clinical Remote Data Capture RDC Onsite 4 6 List of Abbreviations Adverse Event CC CCEB CDM CRCU Clinical Research Computing Unit CRF DEW DM DMS FDA ICH IE IFPMA INV MedDRA NIH OC OPA OS PC PDF QA QC RC RDC SAE SOM V1 0 20140915 Coordinating Center CCEB Center for Clinical Epidemiology and Biostatistics Clinical Data Management Concomitant Medication Log Case Report Form Data Entry Window Data Manager Data Management System Food and Drug Administration cH International Conference on Harmonization Internet Explorer International Federation of Pharmaceutical Manufacturers and Associations Investigator Medical Dictionary for Regulatory Activities National Institutes of Health Oracle Clinical OPA Oracle Project Administration Operating System Personal Computer
68. y v Show All v F y e fa Entry V Discrepancy All Vi Approval Al Y Verification All F M CRF Name AI v Visit All Casebook A Clear Go The features of this Search section are similar to the Search section on the Home Page V1 0 20140915 Oracle Clinical User s Manual Page 17 of 60 Oracle Clinical Remote Data Capture RDC Onsite 4 6 Patient Range A G Assigned Book Any Show All 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 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 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
69. ystem 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 Itis utilized when you use the Tab Oracle Clinical Users Manual Page 58 of 60 S T save save complete save incomplete site time point timestamp univariate discrepancy unplanned unplanned CRF update user role validation validation error V1 0 20140915 Oracle Clinical Remote Data Capture RDC Onsite 4 6 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 is 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 given study A significant even in the history of a CRF Used as criterion when viewing the Audit Trail tab Examples of time points include e creation date e verification dates e approval dates A value assigned to a data point 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 A discrepancy that is dependent on t

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