Overview
Overview
This workshop provides training to key personnel who are involved in submitting results to ClinicalTrials.gov for their academic organization (see “Who Should Attend?” below). The workshop is led by ClinicalTrials.gov staff and 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).

Who should attend?
The target attendees are personnel responsible for providing ClinicalTrials.gov training and support to others at their academic organization. The workshop will provide the attendee with basic tools for helping to ensure results from their organization are successfully submitted to ClinicalTrials.gov. The workshop is best suited for individuals who have beginner or intermediate knowledge of the results database and are already familiar with the PRS, FDAAA 801 and 42 CFR Part 11.

Requirements
The workshop is free, and attendees are responsible for their own travel and hotel accommodations. Attendees are required to bring their own laptop with wireless connectivity capability. Space is limited.

Future Workshops
Another Results Database Train-the-Trainer Workshop is scheduled for May 18-19, 2020 at the NIH campus in Bethesda, MD. Registration will open in 2020. More information on this workshop will be made available on the ClinicalTrials.gov
Training Materials page. 

U.S. Department of Health and Human Services NLM