42 CFR Part 11
PART 11—CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION SUBMISSION
- PART 11—CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION SUBMISSION
- Chapter I—Public Health Service, Department of Health and Human Services › Subchapter A—General Provisions
- Subpart A—General Provisions
- § 11.2 What is the purpose of this part?
- § 11.4 To whom does this part apply?
- § 11.6 What are the requirements for the submission of truthful information?
- § 11.8 In what format must clinical trial information be submitted?
- § 11.10 What definitions apply to this part?
- Subpart B—Registration
- § 11.20 Who must submit clinical trial registration information?
- § 11.22 Which applicable clinical trials must be registered?
- § 11.24 When must clinical trial registration information be submitted?
- § 11.28 What constitutes clinical trial registration information?
- § 11.35 By when will the NIH Director post clinical trial registration information submitted under § 11.28?
- Subpart C—Results Information Submission
- § 11.40 Who must submit clinical trial results information?
- § 11.42 For which applicable clinical trials must clinical trial results information be submitted?
- § 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42?
- § 11.48 What constitutes clinical trial results information?
- § 11.52 By when will the NIH Director post submitted clinical trial results information?
- § 11.54 What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission?
- Subpart D—Additional Submission of Clinical Trial Information
- § 11.60 What requirements apply to the voluntary submission of clinical trial information for clinical trials of FDA-regulated drug products (including biological products) and device products?
- § 11.62 What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health?
- § 11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected?
- Subpart E—Potential Legal Consequences of Non-Compliance
- § 11.66 What are potential legal consequences of not complying with the requirements of this part?
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