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Part 11
FEDERAL · 42 CFR
Part 11 — Clinical Trials Registration and Results Information Submission
20 sections · Title 42: Public Health
§ 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?
§ 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?
§ 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?
§ 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?
§ 11.66
What are potential legal consequences of not complying with the requirements of this part?