HRPP Compliance Office Spotlight

August 20, 2019

What do the HRPP Compliance Analysts do?

The HRPP Compliance Office is responsible for post IRB approval monitoring and ancillary reviews of clinical research to provide oversight over regulatory areas that affect clinical research not addressed in the IRB requirements. For example, the Compliance office provides education and oversight with the FDA requirements for investigational new drugs and devices (21 CFR 312, 21 CFR 812), registration with (42 CFR 11, NIH Policy on Dissemination of NIH-Funded Clinical Trial Information), ICH-GCP (E6 R2) guidelines and the HIPAA Privacy Rule (45 CFR 160, 162, 164, 74 FR 42740).