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 studies which have undergone an initial PRC Review.
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. In the event of low accrual, upon completing the relevant sections of this form no separate low accrual memo is required.
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 Applicatio).
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.