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).
UPDATED POLICY ON SUBMISSION TIMEFRAME:
- Renewals can now be submitted to the PRC concurrent with the IRB Renewal review. All PRC required documents remain the same, but you no longer need to wait for a PRC decision to move forward with submission to IRB for renewal (however, the PRC submission should be made at the same time).
- Note: It is important that the PRC Cover Sheet and IRB Renewal Application numbers are congruent (particularly since once the IRB Renewal is submitted you can’t modify the numbers)
UPDATED POLICY ON STUDIES UNDERGOING CIRB RENEWAL REVIEW:
- It is understood that some studies may not have been open for a full cycle before they are required to be submitted for renewal review. However, these studies should still be submitted to the PRC for renewal review concurrent with the submission to the IRB for continuation review.
- Because a study may not have had enough time to determine if they are performing poorly, and CIRB renewed study which has been open to accrual for less than six months does NOT need to provide a low accrual rationale if accrual is below target.
- HOWEVER: Please provide a brief statement on the PRC Cover Sheet to indicate that the study is CIRB reviewed, and the date which the study opened to accrual at UNC.
This Cover Sheet has been revised and streamlined to provide clearer guidance on what is required for PRC Renewal Review, and ask more focused questions regarding updated information relevant to PRC Renewal Review. Included in this form are areas to indicate updates to accrual goals, updates to Co-Investigators, and specific guidance regarding what constitutes low accrual. In the event there has been low accrual, this form also highlights what is required to address low accrual. Please read carefully and contact the PRC Coordinator if any questions regarding how to complete the requirements for this form.
2. Current Protocol
3. IRB Renewal Application - HINT: To obtain a PDF copy of your IRB Renewal Application, navigate to the renewal application in IRBIS and click the PDF button in the top right hand corner to save a copy to your hard drive for PRC electronic submission.
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, information must be provided to address low accrual and plans to foster accrual. Please see the PRC Renewal Cover Sheet (#1 above) for guidance regarding what constitutes "low accrual" for PRC purposes, and what to provide in the case of low accruing studies.
7. All SAE's and/or Unanticipated Problems (UP's) since time of last renewal review (if not already delineated in the IRB Renewal Application).
8. DSMC or DSMB Report Letter(s) since time of last Renewal (if available).
9. Audit Report Letter(s) or Monitoring Letters since time of last Renewal (if available).
10. Any new information on toxicity/safety of the treatments involved in the trial that might affect the overall safety of participants, if not already outlined in the IRB Renewal Application or other submitted documents.