The subject of 42 cfr part 11 encompasses a wide range of important elements. eCFR :: 42 CFR Part 11 -- Clinical Trials Registration and Results .... Title 42 Displaying title 42, up to date as of 9/29/2025. Title 42 was last amended 9/25/2025. Equally important, fDAAA 801 and the Final Rule - ClinicalTrials.gov. Regulations (42 CFR Part 11) The Final Rule addresses the statutory requirement for the submission of summary results information for applicable clinical trials of drug products (including biological products) and device products that are approved, licensed, or cleared by FDA.
42 CFR Part 11 - LII / Legal Information Institute. LII Electronic Code of Federal Regulations (e-CFR) 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 42 CFR 11 - eCFR - Electronic Code of Federal Regulations e-CFR. This perspective suggests that, title 42, part 11 of the Electronic Code of Federal Regulations.
Policy and Regulation on ClinicalTrials.gov Registration and Reporting. Moreover, this regulation, 42 CFR Part 11, is called the Final Rule for Clinical Trials Registration and Results Information Submission, or "Final Rule". The Final Rule describes requirements for registering and submitting summary results information for certain clinical trials to ClinicalTrials.gov. FDA's Role: ClinicalTrials.gov Information. Federal law requires responsible parties to register with and submit results information to the ClinicalTrials.gov data bank for certain applicable clinical trials.
Transparency of clinical trial... 42 CFR 11 - CLINICAL TRIALS REGISTRATION AND RESULTS ... Equally important, dEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 11 RIN 0925-AA71 ....
NIH-2024-0001] RIN 0925-AA71 Clinical Trials Registration and Results Information Submission eCFR :: 42 CFR Part 11 Subpart A -- General Provisions. Enroll or enrolled means a human subject's, or their legally authorized representative's, agreement to participate in a clinical trial following completion of the informed consent process, as required in 21 CFR part 50 and/or 45 CFR part 46, as applicable.
Provides the text of the Part 11.
📝 Summary
As demonstrated, 42 cfr part 11 serves as a valuable field that merits understanding. In the future, further exploration on this topic may yield more comprehensive understanding and value.