Sites and investigators struggling with obtaining informed consent from patients in quarantine or in the hospital can use the FDA’s free COVID MyStudies app. The app sends a consent form electronically to the patient for signature. The site then can access the signed consent through a secure portal and either print or transfer it electronically.

For access to the app, contact the agency’s Real-World Evidence Program at CDERMedicalPolicy-RealWorldEvidence@fda.hhs.gov.