Avoiding Pitfalls in ClinicalTrials.gov Registration

An interactive, virtual training for how to meet ClinicalTrials.gov requirements while strengthening scientific practices

What is this offering?

• Part 1: Outcome Measures – Why Plain Language Matters in the Age of Transparency
• Part 2: Individual Participant Data Sharing Plans: What, Why, and How to Write One

ClinicalTrials.gov requirements and publisher expectations are changing the way studies are designed and publicized. Policies encouraging transparency and data sharing affect trial registrations, updates, results reporting, and informed consent. Even if you have assistance with your ClinicalTrials.gov registration, you will save time and energy from grant application through the registration process if you understand ClinicalTrials.gov terminology and data sharing expectations. In this interactive, virtual session participants will learn from regulatory and data sharing specialists about how to meet these requirements while strengthening scientific practices.

Primary audience: Investigators and senior study team members from the University of Michigan or affiliated organizations who are involved in planning Investigator-Initiated Studies but have not started enrolling. Anyone with a basic knowledge of clinical trials is welcome. Due to confidentiality and U-M-specific policies and procedures, only employees from U-M or affiliated health systems or people who are working on a clinical trial with a U-M principal investigator. 

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research.