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.

The workshop topics include: the basic organizational principles of the Protocol Registration and Results System (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 also provides 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).

This page links to course materials from August 2021. To learn about future workshops, please see the ClinicalTrials.gov web site.

Overview of Clinical Trial Transparency and Disclosure Landscape

• History of the Clinical Trial Transparency and Disclosure Landscape - Resources (pdf)
• How Does ClinicalTrials.gov Fit into the Clinical Trial Disclosure Landscape? - Resources (pdf)
• How Does ClinicalTrials.gov Advance Clinical Trial Transparency? - Resources (pdf)

Protocol Registration and Results System (PRS) Overview

• PRS: Accounts - Resources (pdf)
• PRS: Record List - Resources (pdf)
• PRS: Study Record Basics - Resources (pdf)

Clinical Trials Registration & Reporting

• NIH Requirements for Clinical Trials Registration and Reporting - Resources (pdf)

PRS Results Module Introductions

• Introduction to Participant Flow
  • Participant Flow Introduction (pdf)
• Introduction to Baseline Characteristics
  • Baseline Characteristics Introduction (pdf)
• Introduction to Outcome Measures
  • Outcome Measures Introduction (pdf)
• Introduction to Adverse Events
  • Adverse Events Introduction (pdf)
• Introduction to Document Upload
  • Document Upload Introduction (pdf)

For more about submitting studies to the ClinicalTrials.gov system, see the ClinicalTrials.gov web site.