42 CFR Part 11 — Clinical Trials Registration and Results Information Submission
Subpart A — General Provisions
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?