H05 - [IN-PERSON/RECORDED] Postapproval Monitoring (PAM) for Studies Overseen by a Single External IRB of Record: Challenges forLocal Monitoring Programs

This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

Since the Revised Common Rule, there has been an increase in the reliance on a single IRB of record for multi-centered research. With the recent issuance of the FDA NPRM, this trend will continue. Increased reliance on single IRBs for multi-centered research will undoubtedly increase burden on local PAM programs. Challenges may emerge for communication and coordination with the external IRB regarding monitoring for compliance with both the local site's and the external IRB's specific policies and requirements. There will be a need to reimagine local PAM programs and consider strategies for communication, collaboration, and resource utilization.