C03 - Spotlight on Post-Approval Monitoring & Single IRB: What’s Working Now?

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Single IRB (sIRB) review and reliance processes are now established practices for many IRB offices, but QA/QI programs may still be adjusting to this “new normal.” Using the 2021 SMART IRB Harmonization recommendations for post-approval auditing of sIRB studies as a foundation, this session will explore a variety of operational strategies for integrating single IRB projects into post-approval monitoring. Presenters will share lessons learned from both routine and for-cause audits, as well as ideas for fostering greater collaboration and collegiality in this evolving space. Whether your PAM program is fully immersed or just beginning to engage, attendees will be invited to exchange their own successes and challenges in managing sIRB oversight.