On May 29, 2020, the U.S. Food and Drug Administration made available its previously developed FDA MyStudies app to launch the COVID MyStudies app. The COVID MyStudies app replaced the FDA MyStudies app in the Apple App and Google Play Stores.
The COVID MyStudies app allows investigators a free platform to obtain informed consent securely from patients for eligible clinical trials when face-to-face contact was not possible or practical due to COVID-19 control measures. The Agency provided the COVID MyStudies resource after hearing that investigators were having difficulties obtaining informed consent for clinical trials when patients were under isolation in health care facilities or could not travel to outpatient clinics.
Effective September 1, 2022, the COVID MyStudies app that is currently in the Apple App and Google Play stores will no longer be available as funding will have expired. This means that the FDA MyStudies team will no longer support studies within the COVID MyStudies app and access to the consent functionality and secure server will end on this date. The open-source code for the original FDA MyStudies app will continue to be available on GitHub.
If you are currently using the COVID MyStudies app for e-consent collection, FDA encourages you to plan to use an alternative app by early 2022. Our partners at Harvard Pilgrim Health Care Institute will contact you about this change. If you have not been contacted, please email FDACOVIDMyStudiesContact@harvardpilgrim.org for study-specific instructions.
Methods for obtaining informed consent remotely are available in an FDA guidance, Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The guidance encourages investigators to consider using electronic methods of obtaining informed consent, if possible.
Harvard Pilgrim Health Care Institute, which operates the Sentinel and Catalyst systems on behalf of the agency, provides the technical assistance required for the COVID MyStudies app and FDA MyStudies app.
Questions related to the COVID MyStudies app or the FDA MyStudies app should be directed to the CDER Real-World Evidence Program at CDERMedicalPolicy-RealWorldEvidence@fda.hhs.gov.
The FDA MyStudies app will continue to be available open source. Visit FDAs MyStudies Application (App) Technical Background for more information.