Sites & Operations
Decentralized Clinical Trial Elements (DCT Elements)
Decentralized clinical trial elements are individual components of a trial; eConsent, telemedicine visits, home nursing, direct-to-patient drug shipment, ePRO, wearables, local labs; that move trial activities from the central investigative site to the participant's home or community.
FDA's 2024 final guidance Decentralized Clinical Trials for Drugs, Biological Products, and Devices defines acceptable DCT designs, sponsor and investigator oversight expectations, and data integrity requirements. Most DCTs are hybrid (some site visits, some remote), not fully virtual.
DCT elements expand recruitment to underserved geographies and reduce participant burden, but introduce new vendor management and data integration challenges (especially around real-time data review and adverse event capture).
References
Related terms
Decentralized Clinical Trial (DCT)
A decentralized clinical trial (DCT) is a clinical study in which some or all trial activities; recruitment, consent, dosing, monitoring, data capture; occur outside traditional brick-and-mortar sites, typically in the participant's home or community setting and supported by digital tools.
Electronic Patient-Reported Outcomes (ePRO)
Electronic Patient-Reported Outcomes (ePRO) are clinical trial data collected directly from participants via electronic devices (smartphone apps, tablets, web portals) on symptoms, function, quality of life, and treatment experience, without interpretation by a clinician.
Electronic Informed Consent (eConsent)
Electronic informed consent (eConsent) is the use of electronic systems and processes (multimedia, interactive content, electronic signature) to deliver informed consent information to clinical trial participants and to document their consent.
Patient Recruitment Strategy
A patient recruitment strategy is the documented, multi-channel plan a sponsor or CRO uses to identify, engage, screen, and enroll the participants required to meet a clinical trial's enrollment timeline, sample size, and diversity goals.
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