FDA MyStudies Overview


The FDA MyStudies platform provides all of the components necessary to support data collection from mobile applications and the storage of collected data in a compliant data environment. The topics below are intended for developers and administrators who wish to set up a MyStudies instance for collecting data from patients. Set up requires the deployment and configuration of the following components:
  • the Registration Server where participants sign up and create an account
  • the Mobile Client App into which participants enter data
  • the Response Server which handles and stores the responses sent by the Mobile App
  • the Web Configuration Portal, or "Study Designer", where administrators design research questionnaires
There is a separate documentation site for the FDA COVID-19 MyStudies app, with information about using that application for the electronic consent portion of this functionality.

Response Server Topics

Registration Server Topics

Web Configuration Portal Topics

Topics for Mobile App Developers

Related Topics