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Deciphering the Continuing Review Form

Deciphering the Continuing Review Form. Research Compliance Administration Training Presentation Wednesday, August 15, 2007 Presenter: Heather Kemp, MBA Research Compliance Coordinator 278-7812 hkemp@iupui.edu. Continuing Review Timing.

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Deciphering the Continuing Review Form

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  1. Deciphering the Continuing Review Form Research Compliance Administration Training Presentation Wednesday, August 15, 2007 Presenter: Heather Kemp, MBA Research Compliance Coordinator 278-7812 hkemp@iupui.edu

  2. Continuing Review Timing • Initial Email from the RCA Office:Approximately 2 months prior to expiration • Pre-Review by RCA Coordinator is Possible • Initial IRB Review: Approximately 1 month prior to expiration

  3. Continuing Reviews are Submitted to rescr@iupui.edu Expedited Reviews are Distributed to Continuing Review Coordinator for Processing Terminated Reviews are Distributed to Continuing Review Coordinator for Processing Full Board Reviews are Distributed to Board Coordinators (02, 04, 05) for Pre-Review Reviews are Processed in Batches and Reviewed by an IRB Member Weekly Reviews are Processed in Batches and Reviewed by an IRB Member Monthly Materials are Reviewed by IRB Members at the Next Full Board Meeting Upon Final Approval, Copies are Returned to the Investigator Provisions are Sent to the Investigator Reviews are Processed in Batches and Reviewed by an IRB Member Weekly Revised Documents are Submitted to rescr@iupui.edu Provisionally-Approved Reviews are Distributed to Provisional Approval Coordinator for Processing Continuing Review Process

  4. Steps to Success • Get off to a good start.

  5. 1. Get Off to a Good Start • Page i – Definitions and Instructions • Standardizes the completion and review of the study. • Page ii – Updates to RCA procedures and/or regulatory guidelines • Ensures that your study is being conducted in compliance with the current interpretation of FDA and OHRP regulations.

  6. Steps to Success • Get off to a good start. • Be consistent.

  7. 2. Be Consistent. • Section I should match Section VI • Sections IV and V should match SSS and General Information reporting

  8. Steps to Success • Get off to a good start. • Be consistent. • Be accurate.

  9. 3. Be Accurate. • Projected number in Section II must reflect current approval • Actual numbers in Section II must be equal

  10. Steps to Success • Get off to a good start. • Be consistent. • Be accurate. • Be thorough.

  11. 4. Be Thorough. • Complete all questions in Sections II-V

  12. Steps to Success • Get off to a good start. • Be consistent. • Be accurate. • Be thorough. • Be current.

  13. 5. Be Current. • Ensure ICS is up-to-date on regulatory guidelines • Update version date in footer • Use current version of SSS • Update co-Investigator list in SSS Section XXI • Remove co-Investigators who are no longer at the University • Remove co-Investigators who are no longer working on the project • Include location of co-Investigators who are not IUPUI staff (VA, Wishard, Clarian, etc.)

  14. The Table in Section VI is Hieroglyphics?!?

  15. Ongoing, Options 1 & 2Open to Enrollment / Not Yet Initiated • Include in Submission: • Continuing Review Form • SSS and Recruitment Checklist • Use current version • ICS and Assent Document(s) • Up-to-date cost, payment and injury statements • RCA Office as alternate contact to PI during business hours and for questions or problems • OHRP may view records • Addendum Consent if following subjects after withdrawal • Authorization Form • Advertisements, OCR Listing and Letters • Entire Protocol • Do not Include in Submission: • Telephone Screening Tools or Questionnaires • Patient Diaries or Educational Materials

  16. Ongoing, Option 4bClosed to Enrollment, Reconsenting Subjects • Include in Submission: • Continuing Review Form • SSS • Use current version • ICS and Assent Document(s) • Up-to-date cost, payment and injury statements • RCA Office as alternate contact to PI during business hours and for questions or problems • OHRP may view records • Addendum Consent if following subjects after withdrawal • Authorization Form • Entire Protocol • Do not Include in Submission: • Recruitment Checklist • Advertisements, OCR Listing and Letters • Telephone Screening Tools or Questionnaires • Patient Diaries or Educational Materials

  17. Ongoing, Options 3 & 4aData Analysis Only / Closed to Enrollment, Not Reconsenting • Include in Submission: • Continuing Review Form • SSS • Entire Protocol • Do not Include in Submission: • Recruitment Checklist • ICS and Assent Document(s) • Authorization Form • Advertisements, OCR Listing and Letters • Telephone Screening Tools or Questionnaires • Patient Diaries or Educational Materials

  18. Completed, Options 5-7Will Not be Initiated / Completed / Closed Prior to Completion • Include in Submission: • Continuing Review Form • Letter from Sponsor/Coordinating Center/PI that study is being closed and they will no longer access PHI • Do not Include in Submission: • SSS and Recruitment Checklist • ICS and Assent Document(s) • Authorization Form • Advertisements, OCR Listing and Letters • Entire Protocol • Telephone Screening Tools or Questionnaires • Patient Diaries or Educational Materials

  19. Questions?

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