Documentation

Welcome to the Support Portal for the FDA COVID-19 MyStudies mobile app. Studies using the app can obtain informed consent from participants directly from the participant's own mobile device, eliminating contact but ensuring security and privacy.

The resources here will help you explore how the FDA COVID-19 MyStudies app works, how to complete your enrollment Intake Form to get your study added to the app, and ultimately how to retrieve the secured electronic consent forms. Your actual research data collection will be performed via another mechanism.


Using COVID MyStudies for eConsent

Contact FDA by emailing CDERMedicalPolicy-RealWorldEvidence@fda.gov.

Coordinate with the COVID MyStudies app team via the resources in this portal.

Use the app to send informed consent documents and receive completed digital documents.