The application period for this workshop is closed. See the Training Materials page for more information on the workshop.

The ClinicalTrials.gov Results Database Train-the-Trainer Workshop provides training to key personnel involved in submitting results to ClinicalTrials.gov for their academic organizations. The virtual 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). Workshop topics include:

  • Basic organizational principles of the PRS results modules
  • Step-by-step data entry instructions for common study designs
  • Results Review Criteria
  • 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?
Target attendees include personnel responsible for providing ClinicalTrials.gov training and support to others at their academic organizations. The workshop will provide attendees with basic tools to help ensure results 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 PRS, FDAAA 801, and 42 CFR Part 11.

Requirements and Workshop Format
The August 2021 Train-the-Trainer Workshop is free and will be offered in an all-virtual format. Attendees must commit to attending all five two-hour live sessions from 1-3 pm Eastern time on Tuesdays: August 3, August 10, August 17, August 24, and August 31. Between each live session, participants will practice what they have learned in the PRS test system and post questions to ClinicalTrials.gov staff through an online discussion board. Space is limited.

U.S. Department of Health and Human Services NLM