Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.6
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 6 — Unit 6.3.1 |
| Scope | G |
| Document part | § 54.6 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | FDA, Documentation, Sponsor record retention, Investigator, Sponsor |
| Comment | Financial record retention for clinical investigators |
Content
§ 54.6 Recordkeeping and record retention. (a) Financial records of clinical investigators to be retained. An applicant who has submitted a marketing application containing covered clinical studies shall keep on file certain information pertaining to the financial interests of clinical investigators who conducted studies on which the application relies and who are not full or part-time employees of the applicant, as follows: (1) Complete records showing any financial interest or arrangement as described in § 54.4(a)(3)(i) paid to such clinical investigators by the sponsor of the covered study. (2) Complete records showing significant payments of other sorts, as described in § 54.4(a)(3)(ii), made by the sponsor of the covered clinical study to the clinical investigator. (3) Complete records showing any financial interests held by clinical investigators as set forth in §54.4(a)(3)(iii) and (a)(3)(iv). (b) Requirements for maintenance of clinical investigators' financial records. (1) For any application submitted for a covered product, an applicant shall retain records as described in paragraph (a) of this section for 2 years after the date of approval of the application. (2) The person maintaining these records shall, upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to and copy and verify these records.
