Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.6
From GxPlex
| Document information | |
|---|---|
| Reference | USA 42 CFR Part 11 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 42 CFR Part 11 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 42—Public Health
Chapter I—Public Health Service, Department of Health and Human Services Subchapter A—General Provisions Part 11 Clinical Trials Registration and Results Information Submission https://www.ecfr.gov/current/title-42 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Scope | G |
| Document part | § 11.6 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Truthfulness requirements for clinical trial information submission |
Content
§ 11.6 What are the requirements for the submission of truthful information? The clinical trial information submitted by a responsible party under this part shall not be false or misleading in any particular. A responsible party who submits false and/or misleading information is subject to civil monetary penalties and/or other civil or criminal remedies available under U.S. law.
