Title 42, Part 11 — Clinical Trials Registration and Results Information Submission
20 sections
Section 11.2
What is the purpose of this part?
Section 11.4
To whom does this part apply?
Section 11.6
What are the requirements for the submission of truthful information?
Section 11.8
In what format must clinical trial information be submitted?
Section 11.10
What definitions apply to this part?
Section 11.20
Who must submit clinical trial registration information?
Section 11.22
Which applicable clinical trials must be registered?
Section 11.24
When must clinical trial registration information be submitted?
Section 11.28
What constitutes clinical trial registration information?
Section 11.35
By when will the NIH Director post clinical trial registration information submitted under § 11.28?
Section 11.40
Who must submit clinical trial results information?
Section 11.42
For which applicable clinical trials must clinical trial results information be submitted?
Section 11.44
When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42?
Section 11.48
What constitutes clinical trial results information?
Section 11.52
By when will the NIH Director post submitted clinical trial results information?
Section 11.54
What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission?
Section 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?
Section 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?
Section 11.64
When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected?
Section 11.66
What are potential legal consequences of not complying with the requirements of this part?