Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 disclosure
From GxPlex
| Document information | |
|---|---|
| Reference | USA 21 CFR Part 54 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 21 CFR Part 54 |
| 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 54 Financial Disclosure by Clinical Investigators 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 2.3.1 |
| Scope | G |
| Document part | § 54.4
disclosure |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator, FDA, Sponsor, Documentation |
Content
§ 54.4 Certification and disclosure requirements. […] Clinical investigators subject to investigational new drug or investigational device exemption regulations must provide the sponsor of the study with sufficient accurate information needed to allow subsequent disclosure or certification. [...]
