Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.44
From GxPlex
Document Information
| 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 | § 11.44 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | When clinical trial results must be submitted |
Text
§ 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42? (a) Standard submission deadline. In general, for applicable clinical trials subject to § 11.42, clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or in § 11.48, as applicable, must be submitted no later than 1 year after the primary completion date of the applicable clinical trial.
(b) Delayed submission of results information with certification if seeking approval, licensure, or clearance of a new use — (1) General requirements. [...] (2) Two-year limitation. [...] (3) Additional requirements [...] (c) Delayed submission of results with certification if seeking initial approval, licensure, or clearance. — [...] (d) Submitting partial results information [...] (e) Extensions for good cause. [...] (f) Pediatric postmarket surveillance of a device product that is not a clinical trial. [...]
