Guided Notes
Decentralized Trials, eCOA & EHR-to-EDC
Decentralized and hybrid trials, eConsent, eCOA/ePRO, wearables and sensors, home health visits, EHR-to-EDC data flows, and the new data management challenges they bring.
Decentralized and hybrid trials
Slide 1 / 5Decentralized clinical trials (DCTs) move some or all activities to participants' homes: • eConsent and telehealth visits, • home nursing visits and local labs, • direct-to-patient drug shipment, • ePRO apps and wearables. Benefits: easier participation, more diverse populations, continuous data. Regulators (FDA, EMA) have issued guidance on DCT elements.