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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 42 - Public Health |
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Chapter I - Public Health Service, Department of Health and Human Services |
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SubChapter A - General Provisions |
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Part 11 - Clinical Trials Registration and Results Information Submission |
| 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? |