FDA's final guidance on conducting clinical trials with decentralized elements was issued in September 2024. This page reads it by topic, translates each into a sponsor task, and flags where you must read the guidance text itself.
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Elements in protocol
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The short answer
Scope
The guidance describes decentralized elements as trial-related activities that occur outside a traditional clinical trial site, for example at a participant's home or at a local healthcare facility. The guidance applies to drugs, biological products and devices, and its aim is to help sponsors, investigators and others design such trials in line with existing regulations.
For the practical side, such as which tools to choose and how to run visits, see the decentralized clinical trial guide and decentralized vs hybrid vs traditional trials. For how the market has moved since, see the state of decentralized clinical trials 2026. This page does something narrower: it reads what FDA says it expects, one topic at a time.
Topic map
Paraphrased from secondary summaries and hedged accordingly. Left column is the guidance theme; right column is a practical reading, not a quote.
| Theme | What FDA appears to expect | Sponsor task |
|---|---|---|
| Telehealth visits | Telehealth should suit the product and the population, with plans for safety assessments that cannot be done remotely. | Document which assessments are remote, which need in-person visits and why. |
| Local healthcare providers | Routine tasks within their usual scope can be done locally; protocol-specific tasks need trained trial staff. | Define tasks, scope, training and oversight of provider networks you contract. |
| Home delivery of investigational product | Depends on the product's risk and complexity. Shipping must protect integrity, track receipt and manage unused product. | Write a shipment, receipt and return plan; justify which products may leave the site. |
| Digital health technologies | Technology must fit the population, be verified and validated for its purpose, and not exclude people without devices. | Document fitness for purpose and provide an alternative for those without personal devices. |
| Data integrity and management | Protocols and data management plans should account for the decentralized elements and remote data sources. | Map every data source, define who enters it and how discrepancies are resolved. |
| Informed consent | Existing consent rules apply to remote and electronic processes. | Plan identity verification, comprehension support and IRB review. See eConsent regulations. |
| Oversight and delegation | Investigators remain responsible for participants and for supervising delegated tasks. Sponsors oversee vendors. | Keep delegation logs, oversight plans and vendor oversight records current. |
| IRB review | IRBs should be given enough information about the decentralized elements to review them. | Describe each element and the safeguards in the submission. |
Guidance is not binding law. It describes FDA's current thinking. Read the full document for the exact language on each point.
Topic by topic
Read these as working notes for a sponsor team preparing a protocol. They are not quotations.
Telehealth can replace some visits, but only where the assessment can be done reliably at a distance. A blood pressure taken by a participant on a home device is a different measurement from one taken by a nurse with a calibrated device. The protocol should say which, and how remote adverse events are identified and followed up. EDC for telehealth research studies shows how the data side is handled.
A local clinic can carry out routine tasks that are within normal practice. Anything specific to the protocol, particularly decisions on eligibility or safety, belongs to trained trial staff, usually under the principal investigator. If you contract a network of providers, expect to be asked how you oversee them. Home health visits in clinical trials covers the operating side.
Home delivery is viewed through risk. A well-characterised oral product with a known safety profile is a different case from a product that needs administration under observation. Whatever you choose, show how storage conditions are kept, how receipt is confirmed, how unused product comes back and who answers participant questions.
Wearables and apps are acceptable where they fit the purpose and are properly verified and validated; FDA has a separate digital health technology guidance for that. See FDA digital health technologies guidance for clinical trials. Plan for participants who lack a suitable device so participation does not depend on owning one.
More data sources means more places for gaps and discrepancies. Define in the data management plan where each data point originates, how it is transferred and how it is reconciled. Audit trails, access control and validation of the systems that hold the data are expected as in any other trial. See ALCOA+ data integrity.
Remote consent is acceptable within existing rules on informed consent and electronic records, but you need to show how the person was identified, how they could ask questions and how the signature was captured and retained. Give the IRB the full picture of the decentralized elements.
Delegation to remote staff and vendors does not move responsibility. Keep records of who did what, with what training, under whose supervision. A risk-based approach is welcome, which fits with the direction of ICH E6(R3).
Build the visit schedule, ePRO diaries, remote eConsent and eCRFs in the free Capture sandbox and see how the data from each element lands in one record. Free, every feature, no credit card.
Putting it to work
For each visit and assessment, record where it occurs, who does it, and with what equipment.
State why this element suits the product, the condition and the population, and what in-person safeguards remain.
Name who supervises, how often, and how deviations are found. Update the delegation log.
Confirm each system or device is fit for purpose and that alternatives exist for those who cannot use it.
Reflect the elements in the data management plan, monitoring plan and safety plan.
Describe the elements and safeguards in the submission and respond to questions early.
Track deviations tied to decentralized elements and amend the plan when they show a pattern.
Where Capture fits
Capture is a self-serve platform for EDC, eCRF, ePRO, eConsent and randomization. It supports Phase 1 to Phase 3 studies where some activities happen away from the site. It does not ship product, run telehealth or supply wearables of its own; it holds the records those activities produce.
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Can you explain, for each element, why it is appropriate for this product and population?
Is it clear which tasks local providers perform and which are reserved for trial staff?
Is there a documented plan for shipment, receipt, storage, use and return of study product?
Is there verification and validation evidence for each digital tool, and an alternative path for those without devices?
Does the data management plan cover each source, its owner and its reconciliation?
Is the remote consent process described, including identity check and questions?
Are vendors and provider networks covered by an oversight plan and quality agreement?
Has the board received a description of every decentralized element?
It is the final guidance titled Conducting Clinical Trials With Decentralized Elements, issued by FDA in September 2024, which replaced a May 2023 draft. It describes FDA's current thinking on designing and running trials in which some activities occur away from traditional sites.
The guidance focuses on decentralized elements rather than categorising whole trials, and describes them as trial activities that take place outside a traditional site, such as at a participant's home or a local healthcare facility.
FDA guidance documents represent current thinking and are not legally binding requirements, though the regulations they refer to are. Treat it as the expected way to demonstrate compliance and discuss deviations with FDA.
It can depend on the product's risk and complexity. Sponsors are expected to protect product integrity during shipment, track receipt, manage unused product and keep appropriate oversight. Higher-risk products may need in-person administration.
Local providers may perform routine tasks within their normal scope, while protocol-specific tasks go to trained trial staff. Investigators remain responsible for delegated tasks and participants, and sponsors oversee provider networks they contract.
Consent requirements remain those of existing regulations, which also apply to electronic and remote processes. Describe the process to the IRB, including identification, questions and signature. Read the guidance and 21 CFR Part 50 for the exact expectations.
Digital health technologies can be used where they are suitable for the population and fit for purpose, verified and validated, with alternatives for people without devices. FDA has separate guidance on digital health technologies.
Capture holds the records: ePRO, eConsent, eCRFs and wearable sync, with one audit trail. It does not provide telehealth, shipping or devices of its own.
Keep exploring
Decentralized clinical trial guide
Practical guide to running DCTs.
State of decentralized clinical trials 2026
Market view.
FDA digital health technologies guidance
The device side.
eConsent for decentralized trials
Remote consent in practice.
Decentralized vs hybrid vs traditional
Model comparison.
EDC for decentralized clinical trials
Data capture across elements.
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