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 of 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.

Configure system to use a LLM (Large Language Model) to automatically extract data needed for clinical trial matching.
How to share extraction variable definitions across clinical trial sites.
How to review results of clinical trial matching to identify candidate patients.
How the BRIM platform makes chart abstraction fast, flexible and built for collaboration.

Dr. Brittain will describe the available Fitbit data streams in the All of Us Research Program and how the Fitbit data is curated for clinical research and discovery. Results of several recent projects leveraging the combination of Fitbit and EHR data will be discussed and how that data can inform future directions involving clinical trials.

MyCap is a customizable participant-facing mobile application available at no cost to capture patient reported outcomes as part of a REDCap project. MyCap serves as a centralized study ‘home’ (app) for information and actions and facilitates continuous participant engagement and retention. On this webinar, we will provide an overview of the app features and share a use case of MyCap to collect real-time patient-reported outcomes during the early stages of labor.