This activity supports investigators of COVID-19 related drug trials that need a digital platform for patient informed consent when face to face contact is not possible or practical. The COVID MyStudies application allows for secure and remote electronic consent. The end product is a signed consent form emailed to the patient or legally authorized representative and a copy which the investigator can access in a secure and compliant manner through the platform. The investigator can print the form or transfer an electronic copy into another electronic system. Under the FDA-Catalyst program, the Sentinel Operations Center will coordinate the branding and administration of this application.
Funding for use of this system by Investigators, Healthcare delivery systems, and Sponsors is provided by the FDA. COVID MyStudies is currently available in the Apple App and Google Play Stores. Investigators, Healthcare delivery systems, and Sponsors can contact CDERMedicalPolicy-RealWorldEvidence@fda.hhs.gov to get started.
More information about COVID MyStudies can be found here.
Jeffrey Brown, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Kenneth Quinto, MD, MPH; Real World Evidence Analytics, Office of Medical Policy, FDA, Silver Spring, MD
Juliane Reynolds, MPH; Bridget Nolan; Amanda Maynard; Jamie Nolan; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA