Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.

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Session 3: FDAAA Final Rule: Latest Updates from ClinicalTrials.gov

Session Chair(s)

Robert Paarlberg, MS

Principal

Paarlberg & Associates LLC, United States

The Final Rule expanding the registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) was published in the Federal Register on September 21, 2016. The Final Rule had an effective date of January 18, 2017 and a compliance date of April 18, 2017. This session will provide the latest update from NLM on the Final Rule including how the new requirements for results reporting.

Learning Objective :
Describe the requirements to report results under the Final Rule
Recognize how the Final Rule is impacting current processes
Explain how NLM is interpreting the Final Rule requirements

Speaker(s)

Speaker

Rebecca Williams, PharmD, MPH

Essex, Part of Emmes Group, United States

Senior Clinical Trials Subject Matter Expert