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ClinicalTrials.gov: Complying with Requirements in the Final Rule (42 CFR Part 11) and Impacts of 21st Century Cures Act
Session Chair(s)
Rebecca Williams, PHARMD, MPH
Senior Clinical Trials Subject Matter Expert
Essex, part of Emmes Group, United States
The Department of Health and Human Services issued a final rule (42 CFR Part 11), with an April 18, 2017 compliance date, clarifying existing requirements and establishing new requirements for registering and submitting summary results of clinical trials to ClinicalTrials.gov. The 21st Century Cures Act became law in December 2016 and includes provisions related to ClinicalTrials.gov reporting, including stakeholder outreach, reporting of compliance activities, and manufacturer obligations for making available policies about expanded access and linking to ClinicalTrials.gov. This session aims to help clinical trial sponsors understand their legal obligations for submitting registration and results information to ClinicalTrials.gov and the steps taken by NIH under the Cures Act.
Learning Objective : Describe the requirements in 42 CFR Part 11 for the submission of registration and results information by trial sponsors and investigators to ClinicalTrials.gov, including information on expanded access; Discuss potential consequences of noncompliance with 42 CFR Part 11; Describe NIH obligations under the 21st Century Cures Act related to ClinicalTrials.gov.
Speaker(s)
Perspective From ClinicalTrials.gov
Rebecca Williams, PHARMD, MPH
Essex, part of Emmes Group, United States
Senior Clinical Trials Subject Matter Expert