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?