OMB control number
Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
OMB 0910-0733 · HHS/FDA.
OMB 0910-0733
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 is listed under ICR 201903-0910-023.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 Development of Comprehensive Monitoring Plan |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 201903-0910-023 | Extension without change of a currently approved collection | 2019-06-26 | Approved without change | |
| 201512-0910-008 | Extension without change of a currently approved collection | 2016-01-06 | Approved without change | |
| 201210-0910-002 | New collection (Request for a new OMB Control Number) | 2012-10-12 | Approved with change |