Post Approval Monitoring

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Governing Agencies

 

The Common Rule 17 Signatory agencies, including DHHS, FDA and DoD

 

• Human Subjects Research:
  45 CFR 46
  21 CFR 56 
  32 CFR 219

 

• Additional FDA regulations:
  21 CFR 312 (drug)
  21 CFR 812 (device)

 

U.S. Department of Health and Human Services (HHS)

 

Office for Human Research Protection (OHRP)

 

OSU Policies: Human Research Protection Program HRRP Policies, Procedures & Guidelines