Navigating 21 CFR Part 11 compliance is a crucial yet daunting task for clinical researchers and regulatory professionals. This webinar, part of an ongoing effort to enhance compliance understanding and implementation, aims to clarify FDA guidance on electronic records and digital signatures. Specifically tailored for researchers, regulatory representatives, and software support staff at academic institutions, this session will provide a comprehensive overview of the 21 CFR Part 11 requirements within the context of the REDCap Electronic Data Capture System.

An NCATS-supported working group is developing a 21 CFR Part 11 Implementation Guide for REDCap, which will be introduced during the webinar. Attendees will learn practical steps for setting up a compliance program and configuring a REDCap environment that meets FDA submission standards. Join us to gain valuable insights and tools to ensure your clinical trials are compliant, efficient, and ready for regulatory submission. Theresa Baker, Senior Application Analyst, and  Alex Cheng, Assistant Professor of Biomedical Informatics from Vanderbilt Univerity Medical Center will present.

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This event,  hosted by the Trial Innovation Network, is available to the University of Rochester community via the UR Clinical and Translational Science Institute.