Deciphering the Continuing Review Form Research Compliance Administration Training Presentation Wednesday, August 15, 2007 Presenter:Heather Kemp, MBA Research Compliance Coordinator Research Compliance Coordinator

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

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

Steps to Success 1. Get off to a good start.

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

Steps to Success 1. Get off to a good start. 2. Be consistent.

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

Steps to Success 1. Get off to a good start. 2. Be consistent. 3. Be accurate.

3. Be Accurate. Projected number in Section II must reflect current approval Projected number in Section II must reflect current approval Actual numbers in Section II must be equal Actual numbers in Section II must be equal Consented Failed Screening WithdrawnActiveCompletedDiscrepancy BLANK

Steps to Success 1. Get off to a good start. 2. Be consistent. 3. Be accurate. 4. Be thorough.

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

Steps to Success 1. Get off to a good start. 2. Be consistent. 3. Be accurate. 4. Be thorough. 5. Be current.

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

The Table in Section VI is Hieroglyphics?!?

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

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

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

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

Questions?