Trial Design
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.
FDA's 2023 draft guidance "Decentralized Clinical Trials for Drugs, Biological Products, and Devices" formalizes acceptable DCT designs and identifies areas requiring sponsor attention: investigator oversight across multiple locations, drug accountability, eSource integrity, and remote informed consent.
Hybrid trials (a mix of on-site and remote activities) dominate today; fully decentralized trials remain rare and typically apply to low-risk indications. Modern site selection must account for whether the candidate site can support the protocol's hybrid model (telehealth, home nursing, eSource).
Related terms
Clinical Trial Protocol
A clinical trial protocol is the master document that defines a clinical study's objectives, design, methodology, statistical considerations, and operational conduct, and that all investigators must follow to ensure scientific validity and participant safety.
Site Selection (Clinical Trials)
Site selection is the process by which sponsors and CROs identify, evaluate, and choose the clinical trial sites best suited to enroll a given study, based on patient population access, investigator experience, operational capacity, regulatory standing, and historical performance.
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