Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (e)
From GxPlex
| Document information | |
|---|---|
| Reference | USA 21 CFR Part 50 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 21 CFR Part 50 |
| 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 50 Protection of Human Subjects 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 | G |
| Document part | § 50.3
(e) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Sponsor, Definition, Clinical investigation, Medical device |
Content
(e) Sponsor means a person who initiates a clinical investigation, but who does not actually conduct the investigation, i.e., the test article is administered or dispensed to or used involving, a subject under the immediate direction of another individual. A person other than an individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators.
