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

 

VR-CLS CIRB Submission Guidelines

  • Request for User Access - Send completed Request for User Access Forms by email to Laura Donohue (or call  516-622-2049)
  • IRBManager™ Demonstration Webinar
    • Check the box to request a demonstration on the Request for User Access form
    • Email rhart@brany.com

Reporting Timelines

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