FDA MyStudies Overview

2021-10-16

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. This help section contains documentation and links to background information to help you set up and use MyStudies. 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

COVID MyStudies for eConsent

The FDA is hosting a version of the app for electronic consent, available free to approved studies. Learn more about eligibility and using the FDA COVID-19 MyStudies app here:

Note that projects not approved for the FDA COVID-19 MyStudies app have the option of configuring their own version of the app for collecting consent and data. The configuration process is the same as for the full MyStudies program described in the pages here. When configuring the data collection responses, at least one question is required but it can be as simple as "Please rate the informed consent process."

Technical Setup for FDA MyStudies

Begin here:

Response Server Topics

Registration Server Topics

Web Configuration Portal Topics

Topics for Mobile App Developers