Guidance for clinical trials with decentralized elements: Overview

Date published: October 27, 2026

Purpose

This guidance outlines regulatory considerations for conducting clinical trials with decentralized elements in Canada. These considerations are supported by Part C, Division 5 of the Food and Drug Regulations (FDR) and the International Council for Harmonisation’s Guideline for Good Clinical Practice (ICH E6).

In clinical trials with decentralized elements, some or all trial-related activities occur outside traditional trial centres. These activities may be supported by digital health technologies and virtual tools. They may include in-person visits with health care providers or at treatment centres located closer to the participant than the clinical trial site. Activities conducted in a participant’s home may also be offered.

Trials with decentralized elements are sometimes referred to as hybrid, remote or virtual clinical trials.

Health Canada is currently modernizing how clinical trials are regulated. This modernization initiative will better accommodate new trial types and designs. We have published an interim policy to advance targeted elements of this initiative until the proposed Clinical Trials Regulations come into force.

Learn more:

This guidance reflects the interim policy. Once the modernized regulatory framework is in force, we will update the guidance to align with the new regulations.

Scope and application

This guidance applies to any party involved in conducting clinical trials in humans in Canada. This includes:

sponsors
investigators
other third parties such as:
- health care providers
- clinical laboratories
- academia
- service providers such as contract research organizations and other vendors

This guidance concerns the following clinical trials involving drugs in Canada:

phases I to IV
clinical trials involving pharmaceuticals, biologics and radiopharmaceuticals for human use

Similar principles apply to the following products. However, because they’re regulated under different regulations, this guidance does not apply to clinical trials or investigations that evaluate:

medical devices
natural health products
foods for special dietary purposes

The considerations in this guidance focus on clinical trials with decentralized elements. For a complete understanding of the regulatory requirements for clinical trials, including those with decentralized elements, consult:

Policy statements

A clinical trial with decentralized elements incorporates activities that are conducted outside traditional clinical trial centres. Including decentralized elements in a clinical trial can:

reduce barriers to trial participation and increase accessibility
improve access to potentially promising new therapies for a greater number of people
improve and accelerate recruitment by broadening geographic reach and helping to connect a greater diversity of participants
allow researchers and other health care providers to participate in pan‑Canadian research without needing to be geographically co‑located
include more community-based practitioner and participant views in trial design, in line with participant-centred approaches in ICH E6

The regulatory requirements for a clinical trial with decentralized elements are the same as those for trials conducted in traditional settings. The regulatory obligations are the same, but planning and operational approaches may need to be adapted. As well, decentralized elements may involve additional considerations to ensure they comply with all applicable requirements.

Clinical trials with decentralized elements should:

be operationally feasible
be implemented with necessary safeguards and ethical considerations that are in proportion to the potential risks to participants
avoid unnecessary burden on participants, investigators and trial-related personnel or other third parties involved in decentralized elements
- for example, by offering flexible options where possible so participants may opt in or out of decentralized elements, based on their own needs, which may change over the course of the trial

Background

For people in Canada, clinical trials with decentralized elements can reduce the barriers to participating in trials conducted at traditional clinical trial sites. These barriers may include geography and travel, language, family and work responsibilities, health and care requirements or other circumstances. Providing options where people can access a clinical trial closer to home may reduce stress. It may also lead to higher enrolment and retention of participants, which in turn may result in better data.

Decentralized options may also make it easier for participants to more easily access and connect to research efforts, and may increase access to novel treatments. However, while clinical trials with decentralized elements may reduce some barriers to participation, other barriers may be created related to inequities in using technology and accessing reliable internet.

For community-based health care professionals, clinical trials with decentralized elements can make it possible to participate in broader research activities. It can also help their patients access a greater number of clinical trials and potentially beneficial novel treatments.

There is also an opportunity to incorporate community-based practitioner and participant considerations in the planning and design of trials. For example, study visits could be aligned with existing treatment schedules.

However, decentralized elements may create additional burdens for community-based health care professionals related to:

training requirements
appropriately implementing trial procedures
operational complexities, such as requirements for different types of equipment, staffing and oversight, and related financial considerations
logistics around shipping, handling and storing drugs involved in the trial in accordance with the trial protocol
communications between trial personnel and participants who do not regularly visit a traditional trial site

For clinical trial sponsors and investigators, decentralized elements can help accelerate and address challenges with recruiting by reaching geographically and culturally diverse participant groups, such as for rare disease trials. They can improve the ability to recruit and retain a more representative participant population, which may lead to more generalizable and applicable trial results.

Conducting geographically dispersed trial activities under a single clinical trial site can increase logistical burden. But it can also help sponsors reduce other administrative or financial burdens associated with operating or coordinating participant visits across multiple clinical trial sites.

Note about guidance documents in general

Guidance documents provide assistance to industry, health care providers and sponsors on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a drug or clinical trial. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the accompanying notice, Part C, Division 5 of the Food and Drug Regulations, Food and Drugs Act and relevant sections of other applicable guidance documents.

Page details

2026-10-27