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. Cooperative group trials do not need to be reviewed annually by the PRC unless there has been low accrual.

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. Progress Report - Renewal or Termination of IRB Approval of Human Subjects Research on IRB webpage

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

4. Consent Form - for those studies still open to accrual

5. A copy of the summary statements issued by the IRB for each 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.

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