DCT components include remote consent, drug shipment to home, telehealth visits, wearable data collection, and home health visits. FDA's 2023 draft and 2024 final guidance describes considerations for DCTs, including investigator oversight, safety monitoring, and informed consent.
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Glossary Term
Decentralized Clinical Trial (DCT)
Study Design
Also known as: DCT, decentralized trial, remote clinical trial, virtual clinical trial
A clinical trial that uses telemedicine, mobile/local providers, or digital tools to conduct some or all study activities at locations other than a traditional site.
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