Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (b)
From GxPlex
| 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 5 — Unit 5.2.4 |
| Scope | HM |
| Document part | § 312.64
(b) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator safety reporting, Serious adverse event, Safety, Causality, FDA |
Content
§ 312.64 Investigator reports. [...] (b) Safety reports. An investigator must immediately report to the sponsor any serious adverse event, whether or not considered drug related, including those listed in the protocol or investigator brochure and must include an assessment of whether there is a reasonable possibility that the drug caused the event. Study endpoints that are serious adverse events (e.g., all-cause mortality) must be reported in accordance with the protocol unless there is evidence suggesting a causal relationship between the drug and the event (e.g., death from anaphylaxis). In that case, the investigator must immediately report the event to the sponsor. The investigator must record nonserious adverse events and report them to the sponsor according to the timetable for reporting specified in the protocol. [...]
