Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

This information collection supports FDA guidance. Regulations pertaining to investigational new drug applications (21 CFR part 312, currently approved under OMB Control No. 0910-0014) provide for the monitoring of ongoing clinical investigations (see 21 CFR 312.56). To assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof, we developed this agency guidance.

The latest form for Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring expires 2022-07-31 and can be found here.