2024 ClinicalTrials.gov Results Database Train-the-Trainer Workshop

This workshop is led by ClinicalTrials.gov staff and provides training to key personnel who are involved in submitting results to ClinicalTrials.gov for their academic organization. It consists of interactive presentations and hands-on results data entry exercises with the Protocol Registration and Results System (PRS). The workshop topics include: the basic organizational principles of the PRS results modules, step-by-step data entry instructions for common study designs, Results Review Criteria, and navigating the ClinicalTrials.gov website help resources. The workshop will also provide an overview of key laws and policies, including the registration and results submission requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) and its implementing regulations (42 CFR Part 11).

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