Decentralized Trial Elements: Evidence, Oversight and Country Review (2026)

A trial team can replace a hospital visit with three remote activities and still leave the participant with more work. A video consultation, a local blood draw and a home delivery involve different professionals, records and failure paths. Each may be individually feasible while the combined pathway produces an unreviewed laboratory result, an unusable endpoint or a parcel that arrives before treatment authorization. The practical design problem is to connect those activities to an accountable clinical decision.

This report examines medicinal-product trials using decentralized elements. It combines current regulatory documents, an original calculation from a published European country matrix, and proposed operating tests for consent, local healthcare providers, product supply and remote data. The three country walkthroughs cover the United States, Germany and the United Kingdom. They illustrate a review method; a specific trial still needs its own applicable approvals, professional arrangements and documented decisions.

TL;DR

• Start with the activity. Specify its clinical purpose, performer, location, source record and responsible decision-maker before choosing a technology or vendor.
• Keep versions and effective dates separate. FDA's decentralized-elements guidance became final in September 2024. ICH E6(R3) Annex 2 reached Step 4 on June 3, 2026; EMA lists January 15, 2027 as its EU effective date. These milestones have different meanings. [1] [2] [3]
• Read the exact country question. In the October 2025 European matrix, electronic signatures are possible in 25 of 30 jurisdiction cells, while seven cells say a physical meeting is always mandatory during consent. Six jurisdictions have both responses. These are historical, qualified matrix entries, not a current permission census. [4] [5]
• Classify local provider activities before assigning documentation. Usual-care work requiring no detailed protocol knowledge has a different operational profile from a trial-specific assessment. Match training, delegation and records access to the actual activity.
• Approve the failure path. A remote service is ready when interrupted consent, delayed results, temperature excursions, unavailable clinicians and missing data have usable recovery routes.

1. Which version governs the study being built?

As of the September 18, 2026 review cutoff, the final ICH Annex 2 is the June 3, 2026 Step 4 document. It supplements the Principles and Annex 1 and covers decentralized elements, pragmatic elements and real-world data. Its scope therefore extends beyond home visits. A global guideline's finalization is distinct from implementation by a regional authority. The EMA page records an Annex 2 effective date of January 15, 2027, following publication of the EU version in July 2026. [2] [3]

The UK provides a separate example. MHRA states that the amended clinical-trial regulations took full effect on April 28, 2026. Compliance with the ICH GCP principles is a legal requirement, and sponsors and investigators must give due regard to relevant annex guidance. MHRA also explains the role of documented proportionality and impact assessments for ongoing trials. A build team should capture this UK position separately from the EU implementation calendar. [6]

We propose a version record with six fields: document title, jurisdiction, publication date, effective date, trial applicability and the person who resolved that applicability. Add a link to the controlled source and the date checked. For an existing study, record whether a change affects future enrollment, existing participants, system configuration or only supporting procedures. A document update can require a training change without changing a database field; a national authorization condition can require a workflow change even when the database remains technically valid.

Consider a multinational trial with an approved home-nursing plan and a new remote measurement option. The working question is whether the amendment changes participant burden, safety surveillance, endpoint collection, data access or authorized providers. That assessment should produce a finite set of actions: revise the relevant protocol section, obtain the applicable approval, qualify the measurement process, update the participant materials and test the altered data flow. Merely updating a policy's reference from R2 to R3 leaves these operating questions unanswered.

Keep a separate decision date for each country. A project dashboard can show the global technical release alongside national readiness, with the underlying reason visible. For example, a configuration may be available in the validated environment while a particular country's participants remain on the previous approved process. The system should make the applicable version identifiable at the participant and activity level. This proposal is an implementation control, not an additional regulatory filing category.

2. What the European consent matrix actually shows

The EU recommendation paper on decentralized elements, version 02 dated October 1, 2025, contains a country matrix. We transcribed two questions from page 23 and checked their cells against both the rendered PDF and position-preserving text. There are 30 jurisdiction columns. Question 11 asks whether a physical face-to-face meeting is always mandatory during the consent procedure. Question 12 asks whether electronic signatures can replace wet ink. These questions concern different parts of consent. [4]

For Question 11, our coding finds seven “yes,” 18 “no” and five unstated cells. For Question 12, it finds 25 “yes,” one “no” and four unstated cells. An asterisk-only cell and an empty cell both remain unstated in the aggregate, while the public transcription preserves their different raw forms. Every asterisk remains a prompt to read a footnote. The supplement includes the source URL, PDF hash, cell-level coding and calculation. [5]

Six jurisdictions have a yes response to both questions: Bulgaria, Cyprus, Germany, Croatia, Hungary and Portugal. This intersection is useful because it exposes a common category error. A positive electronic-signature response can coexist with a requirement for a physical meeting in the published table. Conversely, a no response to the always-mandatory meeting question leaves other conditions unresolved. Neither response alone settles the acceptability of a particular consent process.

The matrix is a dated planning aid. Measuring European remote-trial adoption, approval volumes or authorization probabilities would require separate datasets with appropriate denominators. The 30 columns are jurisdictions, so treating 25 divided by 30 as an adoption rate would change the unit of analysis. Missing responses also have an explicit meaning: the selected cell does not state yes or no. Counting them as prohibitions would invent evidence.

Use this calculation to structure diligence. A reviewer can ask for the precise national position on the proposed discussion method, identity check, signature category, participant copy and person obtaining consent. Those answers belong together in the country plan. A procurement comparison that asks only whether a platform supports electronic signing is too narrow to answer these questions.

There is also a maintenance lesson. The same 2025 paper contains German shipping footnotes referring to an exemption that ended in December 2023. A 2026 delivery decision needs a current source for the proposed route. The Germany walkthrough below uses current statutory provisions for the relevant questions. A dated table can remain valuable while some of its supporting details need replacement. Our calculation deliberately describes the published matrix rather than certifying its entries as current national law.

3. Describe an element as a clinical and information pathway

A useful unit of design is an activity with a defined output. “Remote visit” is too broad. “A qualified clinician assesses a specified symptom set by video, documents the assessment in the designated source system and escalates a predefined finding to the investigator” is concrete enough to review. It identifies the work, the evidence and the point at which an authorized person must act.

For each activity, we propose recording its purpose, timing, participant location, performer, required competence, relevant protocol knowledge, source location, data destination, review owner and exception route. Record the dependencies as well. A blood draw may depend on consent and a kit; dose authorization may depend on the result; shipment may depend on both authorization and participant availability. These dependencies expose the difference between a completed service and a completed clinical decision.

ICH Annex 2 offers navigation for this review: consent in section 2.2; product management in 2.3 and 3.6; investigator oversight, including usual-care professionals, in 2.4; remote data collection in 3.5.2; and safety assessment in 2.5 and 3.9. The following mapping is our adapted implementation aid, with proposed evidence added. ICH holds copyright in the underlying guideline; this adaptation carries no ICH endorsement. [2]

Suppose a local nurse measures blood pressure for a protocol endpoint. Clarify whether the protocol requires a specific device, rest period, body position, repeated measurements or timing relative to dosing. Those details determine the training and equipment needed. If the activity is instead an ordinary clinical measurement supplied as contextual information, its role may be different. A shared label such as “vital signs” should not obscure a different evidentiary purpose.

The activity map also helps allocate software functions. A scheduling tool can track a visit without being the source of the clinical assessment. An electronic case report form can receive a result while the original laboratory report remains elsewhere. A participant application can collect a symptom report without making a clinical judgment. The operating design should say where each authoritative record originates and how subsequent users recognize corrections.

A practical design review follows one participant through the entire sequence. Ask a site user to demonstrate the next permitted action when a required result is pending, when the participant changes location, and when a vendor reports a failed visit. Record what the user sees and who receives the unresolved issue. This walkthrough often identifies missing handoffs earlier than separate demonstrations of each product's normal workflow.

4. Who is doing local care, and what do they need to know?

FDA's final guidance distinguishes trial personnel who contribute significantly to trial data or need detailed protocol knowledge from local healthcare providers performing routine clinical activities. For IND studies, relevant subinvestigator and Form FDA 1572 considerations follow that distinction. FDA also states that investigators need not maintain a log of local healthcare providers performing trial-related activities; reports should identify the provider and activity date. Applying a blanket “every local provider goes on the delegation log” rule would miss this nuance. [1]

This distinction changes the questions asked during setup. Start by listing the actual procedure and the information required to perform it. Does a clinician need to know the randomization assignment, dosing restrictions, study-specific assessment method or protocol-defined emergency instructions? Does the activity generate a primary endpoint or an eligibility decision? Which parts are ordinary practice, and which depend on study-specific instructions? The answers support the role classification and the associated documentation.

ICH Annex 2 section 2.4.1 similarly distinguishes usual-care activities that require no protocol knowledge from those requiring knowledge of trial documents. It describes arrangements for records, data sharing, privacy and integrity in the first situation, and appropriately trained delegated professionals in the second. Proportionate investigator oversight remains relevant in both. This is a useful conceptual alignment, although the applicable national paperwork still needs its own assessment. [2]

We propose an activity-level responsibility table with separate columns for performer, clinical reviewer, records custodian and issue owner. One organization may fill several columns, but the functions should remain visible. A laboratory can own the original report while an investigator owns the decision about its clinical significance. A vendor can arrange a home visit while the investigator retains responsibilities for the participant under applicable requirements. In US IND studies, 21 CFR 312.60 provides the underlying investigator responsibilities. [7]

Training should follow the work. For a protocol-specific sample collection, useful evidence might include the current collection instructions, a demonstration of label reconciliation and a check of the transport time window. For a clinician providing routine care, the important arrangement may concern how relevant information reaches the investigator and how urgent findings are communicated. Each handoff needs evidence of its own operation alongside any applicable GCP training.

Review changes in personnel as operational events. If the originally selected nurse becomes unavailable, the replacement must satisfy the requirements for the assigned task before performing it. The system should preserve the actual performer and date, while the operating process supplies whatever qualification or training evidence is applicable. Avoid creating fictional continuity by leaving an old provider's name attached to a replacement's work.

Cross-border video consultations add a location question. US HHS guidance describes several mechanisms for practicing across state lines, with requirements varying by state. Capture the participant's relevant location and verify the professional arrangement for that location before the clinical encounter. A platform's ability to connect two people is separate from a professional's authority to provide the service. [8]

5. Remote consent needs a complete sequence

Electronic consent combines communication, understanding, identity, documentation and access to a copy. FDA and OHRP's electronic informed-consent guidance addresses these issues within applicable FDA and HHS regulations. It provides a useful starting point for a US process, while local requirements remain relevant to multinational deployment. [9]

Our proposed test sequence begins before the signature. Confirm which approved materials the participant receives and how the system handles language, accessibility and a request for assistance. Identify the person available for the discussion and the channel for questions. Define how the study handles a representative, a witness or another special circumstance when applicable. Then test the identity and signing steps, including how the participant obtains the completed record.

An interrupted session is particularly revealing. Imagine that the discussion is complete but connectivity fails while the signature is being submitted. A recovery screen should reflect the actual record state. It should neither silently repeat a completed signature nor imply that an unsigned record is complete. The site needs a way to resolve the state and determine what the participant may do next. The test evidence should include the timestamps and records from both sides of the interruption.

A second scenario concerns an updated consent version. The system should identify which version applied when a participant signed, whether a new discussion or consent is required under the approved plan, and which activities depend on completing that step. Historical versions remain part of the trial story. A dashboard that simply changes every participant's displayed document to the newest template can erase the distinction between what was available and what was actually signed.

Access to technology also changes the service design. Offer the alternatives supported by the approved process and assess whether participants can use them. A caregiver helping with a device may have a different role from a legally acceptable representative. Record that distinction instead of allowing whoever controls an email account to become the apparent decision-maker. Evaluate the experience with the intended population, including people who need larger text, translation support or additional time.

Keep identity evidence proportionate to its purpose. The goal is a reliable identity check with appropriate privacy safeguards. Saving a full identity document in every downstream system may create unnecessary copies and access paths. Define what the trial needs to retain to demonstrate the check, which party holds it, and how other authorized users can verify that the step occurred. The chosen design should be reviewed against applicable requirements rather than inherited accidentally from a vendor's default form.

6. A home shipment is a chain of decisions

An investigational product can travel through several organizations before reaching a participant. Design the route around the product and trial: release, allocation, dispensing or supply, transport, receipt, storage, administration, return and final disposition. Each event can require different evidence. A parcel scan establishes a logistics event; confirmation of the recipient, product usability and appropriate administration requires further evidence.

FDA's decentralized-elements guidance discusses product suitability and distribution arrangements, including the investigator's role. ICH Annex 2 also addresses participant receipt, storage, accountability, privacy and communication among the responsible parties. These sources support reviewing the whole pathway while applicable national requirements determine which route is permissible. [1] [2]

We propose three linked records for a temperature-sensitive shipment. The first records authorization and the allocated product. The second records transport conditions and receipt. The third records the disposition after any exception. For example, a temperature alarm should create an actionable hold under the study's approved process. An authorized assessment then determines whether the product can be used, replaced or otherwise handled. A customer-service ticket marked “closed” is insufficient evidence of that clinical and product decision.

Define the meaning of delivery statuses with the logistics provider. “Delivered” might mean left with a household member, placed in a locker or handed to the participant. The trial needs the level of confirmation appropriate to its product and approved pathway. Similarly, a failed delivery should trigger a defined response if it threatens a dosing window. Capture the contact route and responsible person rather than relying on the participant to infer what to do.

Privacy and blinding deserve explicit attention. Labels, text messages and courier instructions can disclose a diagnosis or treatment assignment. Review the information each party needs and the information visible to the participant's household. Test exception messages as well as the normal label: a replacement notification can expose information that the original package successfully concealed. These are proposed threat scenarios for the trial's review, not a claim that a particular shipping method is universally acceptable.

Reconciliation should connect assigned, shipped, received, used, returned and disposed quantities where relevant. Differences need an explanation linked to the participant and product records, with access appropriate to blinding. The purpose is to reconstruct the product pathway and support decisions. It is usually more useful to test a realistic missing-return scenario than to add another generic “accountability completed” checkbox to a dashboard.

7. Remote measurements need a defined denominator

FDA's December 2023 guidance on digital health technologies addresses remote acquisition of data in clinical investigations. Its relevance depends on the particular technology and intended use. A device that produces data successfully in ordinary consumer use may still need a study-specific assessment of whether its measurements are suitable for the planned clinical endpoint. [10]

Define the measure before evaluating availability. Specify the device or software version, measurement conditions, sampling schedule, transformation, acceptance criteria and analysis window. Distinguish the raw signal, a derived daily value and the final endpoint. A change in firmware or an algorithm can affect one or more of these stages. The data management plan should identify which version produced a result and how a change is evaluated before use.

Consider an illustrative seven-day collection period for 100 participants. The scheduled denominator is 700 participant-days. Suppose some data arrive for 630 days, but only 560 days meet the prespecified endpoint-quality criteria. Upload availability is 90.0%, usable coverage is 80.0%, and usable coverage among uploaded days is 88.9%. Each calculation is correct for its own denominator. Calling all three “compliance” would make a performance discussion ambiguous.

The hypothetical 140 days without usable endpoint data also contain two operationally different groups: 70 with no upload and 70 with uploaded but unusable data. The first group could include a device problem, connectivity delay or non-use. The second could include insufficient wear time or a failed quality criterion. Those explanations need evidence; the counts alone do not reveal why the data are missing. A support intervention aimed at connectivity may have little effect on a problem caused by measurement conditions.

Design the status model to preserve this distinction. Useful states may include expected, locally captured, transferred, received, technically accepted, quality-qualified and included in the analysis dataset. The exact states should match the study's architecture. Where a device stores data offline, a late upload may legitimately contain earlier measurements. Preserve collection time, receipt time and any relevant timezone information instead of overwriting all timestamps with ingestion time.

Plan device replacement as an ordinary scenario. Link the old and new identifiers to the correct participant, document the transition, and assess calibration or algorithm differences where relevant. Test duplicate delivery of the same data message and corrections received after an earlier export. The analysis should be able to identify which record was superseded and why. A clean final dataset is more credible when its derivation can be explained from the underlying records.

FDA's October 2024 electronic-systems guidance provides additional context for electronic records, access, audit trails and system controls in clinical investigations. Use it to inform a risk-based validation and records strategy rather than treating a vendor's general security certificate as evidence for every trial use. [11]

8. Safety information must reach a clinical owner

A decentralized pathway can distribute observations across a participant application, local clinic, courier helpline and trial site. Decide which channels are intended for urgent clinical communication and which are reviewed on a scheduled basis. Participant instructions should make that distinction understandable. A wearable dashboard or a questionnaire should not accidentally appear to provide continuous emergency monitoring when the trial has arranged no such service.

For each safety-relevant channel, define who reviews incoming information, the coverage period, the backup route and the evidence of response. Response times should come from the trial's clinical risk assessment and approved procedures. Set the required response interval for each clinically defined situation and document its rationale. A dose-limiting finding and an administrative request can reasonably need different handling.

Test an unavailable primary contact. The demonstration should show how the issue reaches an authorized backup, how the participant receives appropriate instructions, and how the clinical record reflects the decision. Then test information arriving through two channels. A symptom reported during a home visit and again through an application may describe the same event. Reconciliation should preserve both source paths while supporting an accurate safety record.

Local care can continue alongside trial care. The operating arrangement should identify which relevant outside information is expected, how permission and access work, and what happens when a record is delayed. An investigator's review depends on receiving information in a usable form. A contract promising access becomes operationally meaningful only when a person can obtain the record, recognize its origin and act on its contents.

Monitoring can examine these handoffs through targeted samples. Select examples with higher clinical importance or known delays and reconstruct the timeline from observation to assessment and resolution. Record whether the failure concerns capture, transmission, routing, review or action. This classification makes remediation more specific: retraining a clinician does little to fix a message routed to an inactive account.

9. Three country walkthroughs for the same proposed activity

Assume a medicinal-product trial proposes remote consent, a local laboratory draw, video follow-up and home supply. The following walkthroughs ask what must be resolved before those elements are enabled. They are deliberately limited to selected questions and current primary sources; they do not constitute complete national legal checklists.

United States: classify the activity and the location

Start with the IND context, investigator responsibilities and the actual contribution of each professional. Apply the FDA guidance's distinction between routine local care and trial-specific work to the proposed laboratory and follow-up activities. Confirm the relevant Form FDA 1572 treatment of personnel and laboratories. Then check the professional arrangement against the participant's location for the video encounter. The state-licensure question remains separate from the federal trial-guidance question. [1] [7] [8]

Our proposed release evidence consists of an activity classification, a reviewed consent pathway, the records-access arrangement, the applicable professional authorization and a tested result-escalation route. A site should be able to identify the performer and source of a laboratory result and obtain a corrected report when needed. Product distribution requires its own suitability and accountability assessment. These records should support the actual route selected for the trial rather than a generic statement that the study “uses DCT.”

Germany: use current provisions for consent and supply

The EU Clinical Trials Regulation supplies the broader framework. Current German AMG section 40b addresses supplementary consent requirements, including the relationship to Article 29 and the relevant qualified professional conducting the discussion. Evaluate the planned consent process against that current provision and the trial's applicable approvals. The historical country-matrix cell alone cannot settle the method for a particular study. [12] [13]

For the specified direct-supply route, current AMG section 47(2a) describes conditions including a case-specific sponsor assessment, participant safety and data validity, protection against sponsor identification of participants, and authorization by the competent federal authority. The provision identifies the parties within its scope. It should replace reliance on an expired exception in an older footnote. A trial team must still determine whether its precise supply arrangement falls within that route and satisfies the conditions. [14]

Our proposed build consequence is a country-specific supply configuration tied to the reviewed authorization and responsible parties. Test who sees the home address, who can associate it with the participant's study identifier, and which party can authorize a shipment. Preserve the applicable conditions in the operational instructions. If the approved route changes, evaluate the interface permissions as well as the courier contract; a privacy restriction can be defeated by an unchanged data export.

United Kingdom: document proportionality and role allocation

The HRA's decentralized-trial position supports appropriate use of decentralized methods with risk assessment and investigator oversight. MHRA's 2026 GCP guidance explains the legal status of the principles and the need to consider relevant annex guidance. Its roles-and-responsibilities guidance helps frame allocation of activities and proportionate training. Read these together for the proposed UK pathway. [15] [6] [16]

We propose a release discussion that examines the endpoint's importance, participant risks, the professional performing each task and the records available to the investigator. Document why the selected oversight is adequate and what would trigger additional review. A routine-care activity may warrant different training from a protocol-specific assessment. The record should explain that distinction through the assigned work, with a practical mechanism for obtaining the resulting information.

Across all three walkthroughs, maintain a concise unresolved-issues list with an owner and a specific decision needed. “Legal review pending” is too broad to guide a build. “Confirm whether the proposed dispenser may use the approved home-delivery route” points to a concrete dependency. The country may proceed with unaffected activities while the dependent activity remains controlled under the applicable approved plan.

10. Data access, privacy and exit belong in the initial design

Map each party's data needs separately. The home nurse may require the address and procedure instructions. A central statistical team may require a coded measurement and relevant covariates. A logistics provider may need delivery details without an endpoint record. Allocate access according to each organization’s assigned responsibilities and justified information needs.

In Europe, the GDPR framework includes lawful-basis requirements, conditions for special-category data, processor arrangements and international-transfer rules. Trial consent and the legal basis for data processing require distinct analysis. In the United States, HIPAA coverage depends on the relevant entity and relationship; a particular data flow needs an assessment of coverage and the necessary arrangements, beyond a general application-level “HIPAA compliant” description. [17] [18]

We propose a data-flow inventory that records source, recipient, purpose, identifier, access role, transfer method and retention owner. Add a route for participant requests and a plan for security incidents. Test access removal when a provider leaves the study and changes to access when a participant transfers between sites. The design should preserve necessary trial records while making current operational access reflect current responsibilities.

Vendor exit should be demonstrated before dependence becomes difficult to reverse. Request an export containing the records and metadata needed for the trial's intended use, then verify that an authorized reviewer can interpret it. Check how audit history, corrections, attachments, code lists and timestamps are represented. A folder of flattened PDFs may be suitable for some records and inadequate for reconstructing a measurement pipeline; the intended evidentiary purpose determines the assessment.

Specify who will maintain access after study closure, contract termination or a supplier's service change. Include a practical retrieval test and an agreed process for changes in file format. These proposed controls help turn a contractual promise of data ownership into an operational ability to use and inspect the records. They should be scaled to the data's importance and the trial's actual system architecture.

11. What should pass before participant use?

A useful release meeting reviews evidence from representative pathways and deliberate interruptions. The scope should reflect the approved protocol, national conditions and the importance of the data. We propose six test families below. They are examples for a study-specific validation and readiness plan, rather than a universal regulatory checklist.

For each test, record the starting state, the triggering event, the expected action, the authorized role and the evidence retained. Include at least one failed interface message and one corrected source record. Ask the receiving user to demonstrate that they can distinguish a pending item from a completed one. A technically successful message transfer can still create a clinically misleading status if the receiving system maps it incorrectly.

Review participant burden with the same specificity. Count the tasks the participant must perform, the time-sensitive dependencies and the support channels they must understand. A home option may remove travel while adding device charging, sample packaging or delivery coordination. Obtain feedback from people representative of the intended population and use it to refine instructions and support. The goal is to identify the work actually transferred to participants and caregivers.

Set monitoring measures with explicit denominators. Examples include delayed clinically important results among results requiring review, unresolved delivery exceptions among shipments, and endpoint-usable days among scheduled days. Pair each measure with an action owner and a review interval. Avoid interpreting these process measures as evidence of participant benefit unless the study or a separate evaluation supports that conclusion.

Finally, preserve the reason for each design choice. A well-constructed record connects the selected element to its purpose, applicable requirements, risk assessment, tested controls and ongoing review. That connection allows a later team to explain why a local provider, home shipment or remote measurement was appropriate, and what changed when the original assumptions no longer held.

Methods and limits

The review cutoff is September 18, 2026. Primary-source lanes include FDA and ICH guidance, EU and national legal or regulatory materials, and our original coding of two questions in the EU recommendation's 30-jurisdiction matrix. We inspected the available clinical-trial data catalog during evidence planning; registry counts describe registered study characteristics and cannot determine which decentralized activities a jurisdiction permits. We therefore excluded the draft's aggregate registry counts from the operating conclusions.

The matrix calculation describes the October 2025 publication exactly as coded. It is not a survey of current approvals. We checked selected current sources for the three walkthroughs, while other jurisdictions remain outside their scope. All workload, data-availability and failure scenarios in this report are proposed or hypothetical; none is presented as observed EClinCloud product performance. The public supplement supplies the transcription and calculation so readers can examine the denominator and limitations directly. [5]

Sources

1. FDA — Conducting Clinical Trials With Decentralized Elements, final September 2024.

2. ICH — E6(R3) Annex 2, final Step 4, June 3, 2026. Copyright ICH; section mapping adapted by EClinCloud without endorsement.

3. EMA — ICH E6 Good Clinical Practice, regional publication and effective dates.

4. European Commission, HMA and EMA — Recommendation paper on decentralized elements in clinical trials, V02, October 1, 2025. Country matrix page 23 and national footnotes.

5. EClinCloud — Public country-matrix transcription, source hash and calculations.

6. MHRA — Compliance with ICH E6 GCP in the United Kingdom, updated April 28, 2026.

7. eCFR — 21 CFR 312.60, general responsibilities of investigators.

8. US HHS — Licensing across state lines.

9. FDA and OHRP — Use of Electronic Informed Consent in Clinical Investigations, questions and answers.

10. FDA — Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, December 2023.

11. FDA — Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations, October 2024.

12. EUR-Lex — Regulation (EU) No 536/2014, Clinical Trials Regulation.

13. German federal law — AMG section 40b, supplementary informed-consent provisions.

14. German federal law — AMG section 47, including paragraph 2a on specified trial supply.

15. UK HRA — Decentralised trial methods position statement.

16. MHRA — Clinical trials for medicines: roles and responsibilities.

17. EUR-Lex — Regulation (EU) 2016/679, GDPR.

18. US HHS — HIPAA covered entities and business associates.