For those studies noted below which require PRC renewal submissions, renewals are due at the same time as the UNC IRB renewal review. (If a study files semi-annual renewal submissions with an external IRB, the PRC renewal submission is due only at the same time as the UNC IRB renewal review.) Renewals are due for all studies, whether they are interventional treatment trials, correlative studies or observational studies.
Renewal submissions are due to the PRC for the following studies:
- Studies that are Open to Accrual.
- Studies that are Closed to Accrual but still have subjects on treatment or active follow-up (research-related intervention/interaction with any subjects).
- Studies that are not yet Open to Accrual but more than six months has passed since the PRC Initial review.
- Cooperative Group studies that have not met 40% of their annual accrual goal (as reflected in OnCore) during the past year.
Please upload all documents as a Continuation Review through ePRMS in OnCore. If you do not yet have access to OnCore, please submit the materials to the PRC Coordinator at email@example.com.
- PRC Renewal Cover Sheet
- Most recent IRB Renewal Application from all applicable IRBs (UNC, CIRB, etc.).
- Current Protocol. If the protocol has been amended since the last time it received an annual review by the PRC, also include a track changes version or a Summary of Changes.
- Consent forms for those studies still Open to Accrual (Main, HIPAA, etc.).
- IRB Approval Letters from all applicable IRBS (UNC, CIRB, etc.) for each modification approved since time of last renewal review.
- All SAEs and/or PRIs (NSIs) since time of last renewal review. Documents to be provided for PRIs include the actual report (and any modifications) filed with the applicable IRB (UNC, CIRB, etc.), as well as all responsive IRB letters.
- DSMC or DSMB Report Letters since time of last renewal review, as well as all responsive documents, including CAPAs, addressing any issues outlined in the DSMC or DSMB Report Letters.
- Audit Report Letters and/or Monitoring Letters since time of last renewal review, as well as all responsive documents, including CAPAs, addressing any issues outlined in the Audit Report Letters or Monitoring Letters.
- 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.