Oncology Protocol Review Committee

RENEWALS

Annual Renewals for studies where patients are still being treated (either studies that are open to accrual or studies closed to accrual but still have subjects on active treatment/intervention) must be submitted to the PRC BEFORE submission to the IRB for all LCCC trials, Other Institution trials (Investigator Initiated studies originating at another institution with UNC participating), and pharmaceutical trials.

Submit one copy of all of the below materials to the PRC:

1. PRC Submission Cover Sheet - This sheet acts as a face page for efficient routing through the PRC.

2. IRB Renewal Application - Request for Renewal of IRB Approval or Study Closure on IRB webpage

3. IRB Application - For the IRB application, see the IRB forms webpage.

4. Consent Forms - for those studies still open to accrual (Main, HIPAA, and other consents as applicable)

5. A copy of the summary statements (IRB Approval Letters) issued by the IRB for each modification/amendment approved since last renewal.

6. If target accrual is not met, submit a memo from PI addressing low accrual and plans to foster accrual.

7. All SAE's and/or Unanticipated Problems (UP's) since time of last renewal review.

8. DSMC Approval letter since time of last Renewal (for LCCC Studies ONLY)

9. Audit letter since time of last Renewal (for LCCC Studies ONLY)

PLEASE NOTE: The PRC will not forward IRB renewal submissions for NON-CPO studies.