FDA App Aids Remote Informed Consent
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.