Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (c)
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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 6 — Unit 6.3.1 |
| Scope | HM |
| Document part | § 312.62
(c) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator record retention, Documentation, FDA, Investigational drug (IMP) |
Content
§ 312.62 Investigator recordkeeping and record retention. [...] (c) Record retention. An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.
