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Oracle Clinical Remote Data Capture System (RDC) Presentation

Oracle Clinical Remote Data Capture System (RDC) Presentation. Introduction to RDC Application (v4.5.0). *** Please Note ***.

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Oracle Clinical Remote Data Capture System (RDC) Presentation

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  1. Oracle Clinical Remote Data Capture System (RDC) Presentation Introduction to RDC Application (v4.5.0)

  2. ***Please Note*** The information contained in the following presentation is for the general training and review of Investigator Sites and employees of Biogen Idec participating in studies utilizing Oracle Clinical Remote Data Capture. This presentation should not be reproduced, republished or retransmitted without the prior consent of Biogen Idec.  

  3. Agenda • Discussion of RDC • Log-in and Navigation of RDC • Demonstration • Data Capture Procedures • Demonstration • Browsing Data • Discrepancy Management • Demonstration • Logging Off • eCRF Verification • eCRF Approval • Archival • Technical and Clinical Support • Q&A

  4. What is RDC? • Remote Data Capture (RDC) is a Web-based tool used at Investigator Sites to record, store and manage clinical study data. This process allows for Investigator Site and Sponsors to view clinical data directly in the sponsors Oracle Clinical database at time of entry, address any discrepant data as needed and sign or approve electronic case report forms (eCRFs)

  5. Benefits of RDC • Improves Overall Data Quality by allowing… • the Sponsor to have real time access to the data • discrepant data to be immediately identified and resolved in a timely manor • CRAs’ to monitor site data remotely and prepare for monitoring visits • No paper!

  6. Workflow in RDC Data entered by site staff System-generated discrepancies Site staff correct eCRF Discrepancy closed by system, CRA or DM Changes rejected Site staff correct eCRF or comment on entered data Validation checks CRA reviews changes or comments CRA performs SDV Investigator approves eCRF Casebook CRA verifies eCRF *Manual discrepancies may be generated by the CRA or CDA anytime after data has been source verified. These discrepancies will follow the same flow as above.

  7. Responsibilities Within RDC • Study Coordinator • Data Entry and review of eCRFs • Review and Respond to Discrepancies • Create Investigator comments in data field when needed • Notify Investigator when eCRFs are ready for review and approval • Investigator • Data Entry and review of eCRFs • Review and Respond to Discrepancies • Approve (sign) eCRF Casebook

  8. Responsibilities Within RDC • Clinical Research Associate (CRA) • Review Data and create Manual Discrepancies when needed • Advise Site Coordinator with discrepancy and data entry questions • Close discrepancies • Perform Source Verification, marking the eCRFs as ‘verified’ • Data Management • Review and perform cross checks of data and create Manual Discrepancies when needed • Provide metrics and status to Study Team • Advise CRA with discrepancy and data entry questions • Lock clean eCRFs • Lock Database

  9. Login and Navigation

  10. LoginInitial Information • Prior to training you will receive… • Username and Password that will provide you with secure access to the Biogen Idec web portal • Web address for Oracle Clinical RDC Training data base • Username and Password for OC-RDC • Post OC RDC training you will receive… • Access to OC-RDC Production data base • The same username and password will be used for both test and production data base

  11. LoginPasswords Passwords • Passwords must be changed after initial login • They must be at least 8 characters in length • Passwords will expire every 90 days • Passwords cannot be re-used To be compliant with the FDA Guidelines: 21 CRF Part 11 it is imperative that you DO NOT SHARE YOUR USERNAME OR PASSWORD

  12. LoginPasswords • To update your password • At the Log in Screen click on Change Password under the Login button

  13. LoginLaunch Application Once logged into Biogen Idec Website… • Click on the following link to launch OC-RDC: http://carl.biogenidec.com/opa45/rdclaunch.htm • Click Log In

  14. LoginLaunch Application The OC RDC log in screen will appear Enter • OC User Name • Password • Database Name (PCDS) Click Connect to log in

  15. Log InLaunch Application A separate OC-RDC window will also appear This screen must remain open to maintain your connection to OC RDC however you may click on the minimize icon if needed

  16. Log InLaunch Study If you have access to multiple studies the Change Study box will appear • Click the appropriate study • Click Ok Note: If you only have access to one study hit F9. This will automatically select the study for you

  17. NavigationNews Updates • News Updates • Any news updates will appear in a centered pop-up window • News updates can be study related and will also be used to alert you to scheduled maintenance • Make use of scroll bars to review any new or existing news messages • If no news is available or active then the search window is automatically activated

  18. Navigation Activities Window The activity list window will appear The list allows you to choose the activity you would like to perform, you can browse all of the data, review eCRFs with discrepancies, or review eCRFs with discrepancies for other users.

  19. Navigation Search Window • To refine your search you can click on Search an this window will appear The Search Window provides you with the ability to filter on certain areas of data you would like to work on

  20. NavigationSearch Window Using the search window you can : • Select and display only the casebook you need to work on • Select and display multiple patients by visit or visit date • Browse certain types of eCRFs • Search for eCRFs that need to be verified and/or signed by the Investigator Note:If no data has been entered for a site then at least the patient must be selected

  21. NavigationSearch Window Criteria Search Window Criteria • Book: Dependent on type of study: • Non cohort studies use only one book which will default • For Cohort studies select the appropriate book assigned by patient • Site: Study sites will use their default Site, CRAs with more than one site will need to select the appropriate site • Patients: Used to define a range of patients by study number

  22. NavigationSearch Window Criteria • Visits/Pages: Used to define a range of visits/pages • CRF Status: • Used to filter for complete, partially complete or blank eCRF’s • Discrepancy status can be used to filter for actionable (red), un-actionable (yellow) or eCRF’s which have no discrepancies • CRA’s can filter for Unverified pages to prepare for their next monitoring visit • Approved eCRFs can be used to confirm that the Investigator has approved the data on each of the subjects at their site.

  23. Navigation Search Window Criteria • Date Window: Can be used to define the Date range that a page was initially entered: • Data: Specific drill down menu which can be used to filter on specific data points entered

  24. NavigationOC-RDC Spreadsheet Once you select the search criteria the OC-RDC Spreadsheet will appear

  25. NavigationOC-RDC Spreadsheet Spreadsheet screen set up: • Rows = Patients (Additional patients can be displayed by using the drop down) • Columns = Pages • Tabs = Visit (Tabs Drop Down should always display by Visit)

  26. NavigationMenu and Tool Bar OC-RDC navigation functions are similar to Microsoft Windows • Example Use the Menu Bar to.. • File Save • Insert Patient Use the Tool Bar to… Add a Patient Add Investigator Comment Create a Manual Discrepancy

  27. NavigationKey Commands Use Key Commands to… • Perform all the same tasks you would using your mouse Example: Press Alt + I to select Insert function from the drop down menu. From this menu, Alt + T will insert a new patient …..Or use Function Key during eCRF entry/review to… F6 Insert Patient F10 Save CTRL + U Clear Data Field CTRL + Shift + F11 Add Operator Comment F1 Get Help

  28. NavigationOC-RDC Icons • For eCRF icon description Click on Help RDC Help Topics

  29. NavigationSelecting a Patient • If more than eight patients are selected from the search window then a drop down box is available… • Click on the drop down box and the patients are listed in groups of eight in numerical order • Click on the necessary group and the patients within that group will be displayed on the main screen

  30. NavigationSelecting an eCRF • Once a patient is selected… • Click on appropriate tab to select desired visit • Note: If desired visit is not displayed at the top, click on the to display additional visits • Use the bottom navigation bar to view all eCRFs scheduled per visit • Example: Screening Visit may have 15 expected pages but only 11 are displayed

  31. NavigationSelecting an eCRF • To Open a new eCRF…. • Single Click in empty cell • eCRF Icon will appear

  32. NavigationTask Tabs Task Tabs • Summary – Overall Visit summary. If a page is clicked on, then the overall summary of that page is given • Discrepancies – Displays all the discrepancies for a specific page. It is from this tab that control of discrepancy management takes place • Verification – Tab used by CRA to verify eCRF’s

  33. NavigationTask Tabs • Approval – Tab used by Investigator to approve eCRF’s • Audit Trail – Tab used by all users to monitor changes made to data after initial entry has been saved NOTE: If no eCRF is selected then only Study Information tab will be available

  34. DemonstrationLog In and Navigation • Key Point Summary • Log In to Biogen Idec Web Portal • Click on RDC link and Log in to OC-RDC • Select Study • Select Search Criteria • Select Patient • Select Visit • Open eCRF • Review Tool and Menu Bars

  35. Data Capture Procedures

  36. Data Capture ProceduresSubject Identification • Patient numbers will be pre-entered by Data Management staff into the system when the subjects’ are randomized. • Subject ID numbers will be seven digits the first three digits will be the site number, then a (-) followed by the subject ID number. 123-456 • The Study coordinator will select the appropriate patient number • This patient number will automatically populate on all eCRF pages for that subject

  37. Data Capture ProceduresHeader Information Header Information Do not enter any details (visit date or comment) in this section UNLESS no data will be collected for that eCRF. In that case only the Blank field can be used

  38. Data Capture ProceduresMarking an eCRF Blank • To mark an eCRF Blank… • Click in the blank box in the header • Click OK on the Forms box Note: Once Ok is clicked, the next eCRF for this patient will be displayed

  39. Data Capture ProceduresMarking an eCRF Blank • For eCRF sections that will not have data entered….. • Click on correct tab • Click the Blank box This will automatically mark the section blank

  40. Data Capture ProceduresMarking an eCRF Blank Pages that can be marked blank will be study specific and defined by the study team

  41. Data Capture ProceduresExpanding eCRF Screen • To Expand eCRF Screen for better viewing… • Double Click on the Patient Information bar • Click and drag mouse to outline desired size • Press Done

  42. Data Capture ProceduresData Entry To display contents of eCRF, click in Visit field and Press Tab key Begin Data Entry by typing in the responses and using the Tab Key to navigate from one field to another Tip: Be sure to have the study specific eCRF Completion Guidelines to reference during entry – this will help avoid unnecessary discrepancies

  43. Data Capture ProceduresList of Values Some data fields are not enterable and will have a List of values (LOV) to choose from To select from the LOV • Click on the LOV symbol ‘…’ or Press F9 • Select from the LOV • Click Ok This will place the selection in the data field Tip: you can always Press F1 if you have any questions or need additional help

  44. Data Capture ProceduresDates and Times Dates can be entered using the following formats: • mm/dd/yy • mm/dd/yyyy • mmddyy • mmddyyyy • DDMMMYY • DDMMMYYYY Times should be entered using a 24-hour clock. After entering in the numerical value, press the Tab Key. OC-RDC will automatically add the ‘:’ • Note: Certain date fields allow the entry of Partial Dates and other date fields will prompt a discrepancy stating the it is not a complete date. If the complete date is unknown it is best to close the discrepancy immediately.

  45. Data Capture ProceduresLog Pages Log Pages are kept at the end of the eCRF book and can be located by using the page drop down menu Note: Log pages are displayed in numerical order and should be entered as such. If additional pages are needed then an Unplanned eCRF can be added

  46. Data Capture ProceduresUnplanned eCRF Adding and Unplanned eCRF From drop down menu select Insert Visit Use drop down arrow in the right hand portion of window to select the appropriate eCRF Tip: To easier identify the appropriate eCRF to select, please refer to eCRF Completion Guidelines for page name descriptions

  47. Data Capture ProceduresUnplanned Visit Adding an unplanned visit • Open the current visit • From drop down menu select Insert Visit • Click Ok Note: the Unplanned Visit will be inserted after the visit that is open, i.e. if an unplanned visit occurs post Visit 2 the cursor should be on Visit 2 when you add the visit.

  48. Data Capture ProceduresIndicator Questions Indicator Questions (Yes/No or Done/Not Done) will more easily direct the flow of data entry Example: ‘Any data for this section?’ Y/N question: • If answered ‘Yes’, curser moves to the next data field on the eCRF • If answered ‘No’, entry skips to next question group or page Note: Question Group is a group of questions with a common indicator, generally a polar question. eCRFs can have multiple questions groups.

  49. Data Capture ProceduresRepeating Question Groups Repeating Question Groups • Repeating questions groups are usually displayed in a table format • An eCRF can have several repeating question groups • Once in a repeating question group question, the title bar will indicate how many records exist and which record you have currently selected.

  50. Data Capture ProceduresDelete Row Function • Data Entry for eCRFs with repeated questions groups will prompt an error message if the Tab Key is pressed in the last data field of a blank repeat • Click Ok • Select CRF from Menu Bar • Select Delete Row • Click to close eCRF Note: This error message can be avoided it is best to click the on the top corner of the eCRF after entry is complete and avoid using the Tab Key

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