Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53
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| Document information | |
|---|---|
| Reference | USA 21 CFR Part 312 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | HM |
| Document name | 21 CFR Part 312 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 21 —Food and Drugs
Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter D—Drugs for Human Use Part 312 Investigational New Drug Application https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 2 — Unit 2.2.1 |
| Scope | HM |
| Document part | § 312.53 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Sponsor responsibilities, Investigator, Monitoring, Delegation, FDA |
| Comment | Sponsor responsibilities: selecting investigators and monitors |
Content
§ 312.53 Selecting investigators and monitors. (a) Selecting investigators […] (b) Control of drug. […] (c) Obtaining information from the investigator. [...] (1) A signed investigator statement (Form FDA-1572) containing: […] (2) Curriculum vitae […] (3) Clinical protocol. […] (4) Financial disclosure information [...] (d) Selecting monitors [...]
