Decentralized Clinical Trials (DCTs) Explained

A decentralized clinical trial (DCT) is a clinical investigation in which some or all trial-related activities happen away from a traditional investigator site — at a participant’s home, a local clinic or pharmacy, or through telehealth — rather than requiring participants to travel to a central site for every visit and procedure. DCTs exist on a spectrum: a fully decentralized trial has no traditional site visits at all, while a hybrid trial (the more common design in practice) mixes remote elements with a reduced number of in-person visits. The defining feature is not the absence of a site, but the deliberate use of technology and local resources to move specific trial activities closer to the participant.

FDA’s decentralized clinical trials guidance

The FDA issued final guidance titled Conducting Clinical Trials With Decentralized Elements on September 18, 2024, published via the Federal Register as guidance for industry, investigators, and other interested parties. It applies to trials of drugs, biological products, and devices regulated by FDA, and follows an earlier draft version FDA released for comment in 2023. The final guidance does not create a separate regulatory category for DCTs — a decentralized trial is still subject to the same IND/IDE, Good Clinical Practice, informed consent, and safety-reporting requirements as any other FDA-regulated trial. What the guidance addresses is how sponsors and investigators should apply those existing requirements when specific activities — consent, drug administration, sample collection, safety assessments — are performed outside the traditional investigator site.

Key areas the guidance covers include: the roles and responsibilities of local health care providers (HCPs) who perform trial-related visits or procedures on behalf of the investigator; the sponsor’s obligation to have a documented process for delegating tasks to and overseeing these local HCPs; use of digital health technologies (DHTs) for remote data collection; direct-to-participant (DtP) shipment and administration of investigational products; and standards for remote monitoring and telehealth visits, including how they should be documented as part of the trial record. It also clarifies that IRB oversight of the protocol as a whole is unchanged, but sponsors should describe DCT-specific elements clearly enough in the protocol for the IRB to evaluate them.

Core components of a decentralized trial

eConsent (electronic informed consent)

Most DCTs rely on electronic informed consent to obtain and document consent remotely, since a participant may never come to a physical site. Electronic signatures used for FDA-regulated trial records — consent forms included — must meet 21 CFR Part 11‘s requirements for trustworthy, reliable electronic records and signatures. FDA and HHS’s Office for Human Research Protections have separately addressed the use of electronic consent directly in joint guidance on electronic informed consent in clinical investigations, which recommends IRB review of the electronic consent process and interface itself (not just the consent language), interactive or multimedia elements to support comprehension, and adequate identity verification of the person signing. See CASRAI’s eConsent entry for the operational definition and worked examples.

Remote and risk-based monitoring

Traditional on-site monitoring visits are frequently replaced or supplemented in a DCT with remote source data verification, video-based monitoring visits, and centralized statistical monitoring that flags sites or data patterns for follow-up rather than checking every record on a fixed schedule. This shift is consistent with ICH E6(R3)’s emphasis on quality-by-design and proportionate, risk-based oversight rather than uniform, resource-intensive monitoring regardless of actual risk. See CASRAI’s ICH E6(R3) entry for how the current GCP revision frames risk-based monitoring.

Direct-to-participant (DtP) drug shipment

Investigational product can be shipped directly to a participant’s home, or administered by a local health care provider, instead of being dispensed only at the investigator site. This requires the sponsor to maintain the same chain-of-custody, temperature-control, and accountability records the FDA guidance and existing GMP/IMP-handling expectations require at a site — shipment, receipt confirmation, storage conditions, and administration all need to be documented even though they happen off-site. See CASRAI’s Clinical Trial Supply Management guide for the underlying IMP handling and accountability requirements DCTs still have to satisfy.

Local labs, imaging, and wearables/digital health technologies

Rather than requiring a participant to travel to the central site for blood draws, imaging, or vital-sign checks, a DCT can route these to a local laboratory, mobile phlebotomy service, or imaging center closer to the participant, or capture equivalent data continuously through a wearable or other digital health technology (DHT). Using a local lab or a DHT for trial data introduces its own documentation burden: the sponsor needs evidence the local facility or device produces data of comparable quality and reliability to what the protocol would have obtained at the central site, and the protocol and data management plan need to specify how that data is captured, transmitted, and verified.

How IRB and regulatory considerations differ from a traditional trial

A DCT does not get separately or differently regulated — it is reviewed by an IRB under the same Common Rule (45 CFR 46) and FDA human-subjects-protection framework as any other trial — but several elements typically need more explicit attention in the protocol and IRB submission:

Delegation and oversight of local HCPs. When a participant’s local physician, nurse, or pharmacist performs a trial procedure on the investigator’s behalf, the protocol needs a documented process for how that person is selected, trained, and supervised, and how their work is captured in the trial record.
Consent process and comprehension. Because consent is often obtained remotely, IRBs are expected to review the electronic consent process and interface, not only the language of the form, and to consider whether participants have adequate opportunity to ask questions of study staff.
Safety monitoring without a site visit. Adverse event detection and escalation pathways need to work when a participant is not being seen in person on a fixed schedule — this typically means clearer participant-reported outcome and DHT-based monitoring plans, plus a documented escalation path to the investigator.
Data privacy and security for remote data collection. Telehealth visits, DHTs, and data transmitted from a participant’s home raise data-security and privacy considerations that a fully on-site trial doesn’t have to the same degree, which IRBs and sponsors need to address in the protocol and consent materials.
Multi-jurisdiction practice-of-medicine questions. Telehealth visits and local HCP involvement can raise state/jurisdiction-specific licensure questions that don’t arise when all care is delivered at a single site, and these need to be worked out before the protocol goes into the field, not discovered mid-trial.

Institutions increasingly document these considerations through a Clinical Trial Management System (CTMS) configured to track decentralized-specific activities — local HCP delegation logs, DtP shipment records, remote visit documentation — alongside standard trial data, since these records still need to satisfy the same audit-trail expectations FDA inspectors apply to any other trial record.

Frequently asked questions

Is a decentralized clinical trial regulated differently than a traditional trial?

No. The same IND/IDE, GCP, informed consent, and safety-reporting requirements apply. FDA’s DCT guidance explains how to apply those existing requirements when specific activities happen away from the investigator site — it is not a separate regulatory pathway.

Does a DCT still need IRB approval?

Yes, under the same Common Rule / FDA human-subjects-protection framework as any other trial. The protocol submission should describe the DCT-specific elements — remote consent process, local HCP delegation, DtP shipment, remote monitoring — clearly enough for the IRB to evaluate them.

What is the difference between a hybrid and a fully decentralized trial?

A fully decentralized trial has no traditional in-person site visits; a hybrid trial combines some remote elements (eConsent, remote monitoring, DtP drug shipment) with a reduced number of in-person visits. Hybrid designs are more common in practice, since some procedures (certain imaging, complex infusions) still require a site or specialized facility.

Does eConsent used in a DCT need to comply with 21 CFR Part 11?

Yes. Electronic signatures used to document informed consent for an FDA-regulated clinical investigation fall under 21 CFR Part 11’s requirements for trustworthy, reliable electronic records and signatures, in addition to the substantive informed-consent requirements under the Common Rule and FDA regulations.

Decentralized Clinical Trials (DCTs): What They Are, FDA Guidance, and Key Components