Why Do I Need to Register My Trial and Submit Results ?
Required by Law
The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to (e.g.,ClinicalTrials.gov), in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801). The Final Rule has been in effect since January 18, 2017. For more information on the Final Rule:
See the Final Rule Information page for details on data submission requirements for 42 CFR Part 11, including the formatting of certain types of clinical trial information.
View the archived content for the Final Rule Webinar Series, designed to assist responsible parties further their understanding of the Final Rule.
See the Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (PDF) (June 2018) for complete statutory definitions and more information on the meaning of applicable clinical trial.
View Frequently Asked Questions (FAQs) about the Final Rule (42 CFR Part 11).