Wasc evaluator training webinar spring 2011 (Jan 11, 2011)
IRB Continuing Reviews
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 Review Process 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 Monthly Reviews are Processed in Batches and Reviewed by an IRB Member Weekly 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
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.
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.)
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
