CDER SBIA Webinar: An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies

The FDA released code and technical documentation for the FDA MyStudies Platform on November 20, 2018. External organizations can now use these materials to configure and create branded apps for their own use in traditional clinical trials as well as real world evidence studies and registries.

This event demonstrated the capabilities of the system as well as its associated web-based configuration portal and data storage environment. Developers received an orientation to the GitHub repository and learned helpful tips for setting up and configuring the system for study managers and participants.

Intended Audience:​

• Professionals involved in Clinical Research, Post Market Studies, Regulatory Affairs, Medical Affairs, Real World Evidence, Health Economics and Outcomes Research, and Population Health Management
• Application developers and Secure Data Storage and Analytics Solutions developers working in the health care space
• Foreign regulators

Date: May 9, 2019
Time: 10:00 AM - 3:00 PM EST
Location: Webinar