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Document:USA 42 CFR Part 11 09-Apr-2025: Difference between revisions

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|DocDescription=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
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|DocSubmittedBy=Florian Adragna
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|reference=USA  42 CFR Part 11  09-Apr-2025
|reference=USA  42 CFR Part 11  09-Apr-2025
|validity_area=USA
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Line 37: Line 18:
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<noinclude>
== References ==
{| class="wikitable" style="width:100%;"
! Reference !! Scope !! Document part !! Language !! Preview
|-
| [[Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.4]] || G || § 11.4 || EN || § 11.4 To whom does this part apply? […] (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 § 11.6]] || G || § 11.6 || EN || § 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 § 11.8]] || G || § 11.8 || EN || § 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 § 11.24]] || G || § 11.24 || EN || § 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 § 11.64]] || G || § 11.64 || EN || § 11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected? (a) Updates. […] (b) Corrections— […]
|-
| [[Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.10 (b) (5)]] || G || § 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 § 11.40]] || G || § 11.40 || EN || § 11.40 Who must submit clinical trial results information? The responsible party for an applicable clinical trial specified in § 11.42 must submit clinical trial results information for that ...
|-
| [[Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.44]] || G || § 11.44 || EN || § 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 ...
|-
| [[Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.54]] || G || § 11.54 || EN || § 11.54 What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission? […]
|}
</noinclude>

Latest revision as of 14:15, 16 July 2026


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

References

 ScopeDocument partLanguagePreview
USA 42 CFR Part 11 09-Apr-2025 § 11.10 (b) (5)G§ 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) Interventi…
USA 42 CFR Part 11 09-Apr-2025 § 11.24G§ 11.24EN§ 11.24 When must clinical trial registration information be submitted? (a) General. Except as provided in paragraph (b) of this section, the respons…
USA 42 CFR Part 11 09-Apr-2025 § 11.4G§ 11.4EN§ 11.4 To whom does this part apply?

[…]

(c) Determination of responsible party. For purposes of this part, each applicable clinical trial or other cl…
USA 42 CFR Part 11 09-Apr-2025 § 11.40G§ 11.40EN§ 11.40 Who must submit clinical trial results information? The responsible party for an applicable clinical trial specified in § 11.42 must submit cl…
USA 42 CFR Part 11 09-Apr-2025 § 11.44G§ 11.44EN§ 11.44 When must clinical trial results information be submitted for applicable clinical trials

subject to § 11.42?

(a) Standard submission deadline.…
USA 42 CFR Part 11 09-Apr-2025 § 11.54G§ 11.54EN§ 11.54 What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission? […]…
USA 42 CFR Part 11 09-Apr-2025 § 11.6G§ 11.6EN§ 11.6 What are the requirements for the submission of truthful information? The clinical trial information submitted by a responsible party under thi…
USA 42 CFR Part 11 09-Apr-2025 § 11.64G§ 11.64EN§ 11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected?

(a) Updates. […] (b) Corrections—

[…]…
USA 42 CFR Part 11 09-Apr-2025 § 11.8G§ 11.8EN§ 11.8 In what format must clinical trial information be submitted? Information submitted under this part must be submitted electronically to Clinical…
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