Ensuring compliance with ClinicalTrials.gov requirements is a key institutional responsibility that intersects with IRB review and regulatory oversight. This session provides a detailed examination of federal requirements governing clinical trial registration and results reporting under FDAAA 801, the Common Rule, and NIH policy. ClinicalTrials.gov staff will clarify how these regulations apply to human subjects research oversight, including when registration is required, how Applicable Clinical Trials (ACTs) are identified, and how institutions and IRBs support accurate reporting and documentation.
Designed for IRB professionals and research administrators, the session will highlight institutional policies and procedures that promote compliance, outline common challenges encountered during registration and results reporting, and offer practical strategies for integrating ClinicalTrials.gov checkpoints into existing IRB and HRPP workflows. Attendees will gain a stronger understanding of regulatory reporting obligations and how to effectively educate and guide research teams while maintaining institutional compliance.
Members: $225
Nonmembers: $330