Clinical Trials Registration and Results Information Submission

The National Institutes of Health detailed requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov

Action
Published Date
Code CFR
42 C.F.R. Part 11
Contact Information
Jerry Moore, 301-496-4607
Effective Date
More Information
https://www.gpo.gov/fdsys/pkg/FR-2016-09-21/pdf/2016-22129.pdf
Pages
64981-65157
Program Area
Volume Number
81