Document:USA 42 CFR Part 11 09-Apr-2025: Difference between revisions
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| 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 42โPublic Health
Chapter IโPublic Health Service, Department of Health and Human Services Subchapter AโGeneral 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 | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:USA 42 CFR Part 11 09-Apr-2025 ยง 11.4 | G | ยง 11.4 | EN | ยง 11.4 To whom does this part apply? [โฆ] (c) Determination of responsible party. For purposes of this part, each applicable clinical trial or other clinical trial must have one responsible party. ... |
| Reference:USA 42 CFR Part 11 09-Apr-2025 ยง 11.6 | G | ยง 11.6 | EN | ยง 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 ... |
| Reference:USA 42 CFR Part 11 09-Apr-2025 ยง 11.8 | G | ยง 11.8 | EN | ยง 11.8 In what format must clinical trial information be submitted? Information submitted under this part must be submitted electronically to ClinicalTrials.gov, in the format specified at ... |
| Reference:USA 42 CFR Part 11 09-Apr-2025 ยง 11.24 | G | ยง 11.24 | EN | ยง 11.24 When must clinical trial registration information be submitted? (a) General. Except as provided in paragraph (b) of this section, the responsible party for an applicable clinical trial for ... |
| Reference:USA 42 CFR Part 11 09-Apr-2025 ยง 11.64 | G | ยง 11.64 | EN | ยง 11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected? (a) Updates. [โฆ] (b) Correctionsโ [โฆ] |
| Reference:USA 42 CFR Part 11 09-Apr-2025 ยง 11.10 (b) (5) | G | ยง 11.10
(b) (5) || EN || (5) Study Design means a description of the manner in which the clinical trial will be conducted, including the following information: (i) Interventional Study Model. The strategy for assigning ... | ||
| Reference:USA 42 CFR Part 11 09-Apr-2025 ยง 11.40 | G | ยง 11.40 | EN | ยง 11.40 Who must submit clinical trial results information? The responsible party for an applicable clinical trial specified in ยง 11.42 must submit clinical trial results information for that ... |
| Reference:USA 42 CFR Part 11 09-Apr-2025 ยง 11.44 | G | ยง 11.44 | EN | ยง 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to ยง 11.42? (a) Standard submission deadline. In general, for applicable clinical trials ... |
| Reference:USA 42 CFR Part 11 09-Apr-2025 ยง 11.54 | G | ยง 11.54 | EN | ยง 11.54 What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission? [โฆ] |
