Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.102 (m)
From GxPlex
| Document information | |
|---|---|
| Reference | USA 21 CFR Part 56 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 21 CFR Part 56 |
| 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 A—General Part 56 Institutional Review Boards https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.5.4 |
| Scope | G |
| Document part | § 56.102
(m) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Ethics committee, Definition, Clinical investigation |
Content
§ 56.102 Definitions. [...] (m) IRB approval means the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.
