Page 318 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q021
SOP Title: FDAAA 801, The Final Rule (42 CFR Part 11), and ClinicalTrials.Gov Registration
Results Database and Benefits for Various Groups
5. REGULATIONS
A. Final Rule, Department of Health and Human Services
Clinical Trials Registration and Results Information Submission, 42 CRF Part 11
The DHHS Final Rule clarifies and expands the requirements for submitting clinical trial registration and results information to ClinicalTrials.gov in accordance with Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801).
The Final Rule is intended to make it clear to sponsors, investigators, and the public which trials must be reported, when they must be reported, and whether compliance with requirements has been achieved. This final rule does not impose requirements on the design or conduct of clinical trials or on the data that must be collected during clinical trials. Instead it specifies how data that were collected and analyzed in accordance with a clinical trial’s protocol are submitted to ClinicalTrials.gov. No patient-specific data are required to be submitted by this rule or by the law this rule is intended to implement.
In Summary, The Final Rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric post-market surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH).
SOP No. 24, 07-14-2020, 05-31-2022