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IRB Presentation: The Roadmap to Regulatory Compliance: Guidelines for ClinicalTrials.gov Registration & Results Reporting
This presentation will clarify the key aspects of ClinicalTrials.gov registration and results reporting, with an overview of guidelines and practical tips to avoid common errors that researchers encounter during this process. By the end of this presentation, participants will have a clear understanding of how to meet the Food and Drug Administration Amendments Act (FDAAA 801) standards and ClinicalTrials.gov requirements, ensuring successful trial registration and reporting.
Overview of the ClinicalTrials.gov database.
Which trials need registration & results reporting?
How to Register a study, Report Results, and Update Records.
Common errors during registration, and results reporting, and how to avoid them.
Navigating the PRS Support System and Help content
Overview of ClinicalTrials.gov PRS Beta website
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