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

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Decentralized 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.

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