Virtual Pooled Registry Cancer Linkage System/BRANY Central IRB
BRANY IRB is contracted with NCI to serve as a Central IRB to review Virtual Pooled Registry – Cancer Linkage System (VPR–CLS) studies. The Common Rule requires use of a Central (or single) IRB for cooperative research. Reliance on a Central IRB can eliminate redundancy and provide a consistent, high quality, expert review process that protects privacy and confidentiality while saving time and resources.
To streamline the Central IRB application and review process for VPR-CLS studies, the North American Association of Central Cancer Registries (NAACCR) has developed a Templated IRB/Registry Application (TIRA -common form). Submissions to the BRANY IRB will rely, in part on the TIRA, for much of the information needed for IRB review.
The flow diagram below outlines the process for submitting to NAACCR and BRANY IRB.
VPR-CLS Central IRB Submission Guidelines
|UPIRTSOS (Unanticipated Problems)||Report per occurrence within 5 days|
|Serious Adverse Events (Local)||Report per occurrence within 5 days|
|Unanticipated Adverse Device Events (UADEs)||Report per occurrence within 10 days|
|Complaints||Report per occurrence within 5 days|
|Major Deviations||Report per occurrence within 10 days|
|Minor Deviations||Report in aggregate with continuing review or study closure|