Interim policy for the modernization of the clinical trial framework: Notice

September 14, 2026
Our file number: 26-105996-626

Purpose

The purpose of this notice is to outline Health Canada's interim policy approach to support more flexible and efficient conduct of clinical trials in Canada. This interim policy advances targeted elements of the Clinical Trials Modernization initiative. It aligns Health Canada's requirements with international standards, such as:

current International Council for Harmonization Guideline for Good Clinical Practice (ICH E6)
evolving clinical trial practices, including:
- innovative approaches to trial delivery
- integration with streamlined ethics review models

Health Canada is introducing this interim policy pending the coming into force of the proposed Clinical Trials Regulations. We're currently considering comments from the Canada Gazette Part I consultation on the proposed regulations, which closed on April 19, 2026. This interim policy will be replaced by policies to implement the new Clinical Trials Regulations once they come into force (anticipated for spring 2028).

Learn more:

Background

Health Canada has identified opportunities to immediately advance 3 elements of a modernized clinical trials regulatory framework through policy, using consultations on the:

These elements are:

Updating how to notify Health Canada about ethics approvals in multi-site trials, in line with coordinated ethics review models.
Modernizing the qualification requirements of a "qualified investigator" to support competency-based approaches aligned with ICH E6.
Acceptability of non-traditional "documented" informed consent approaches, including remote and electronic methods.

We intend to formalize these elements when the proposed Clinical Trials Regulations come into force.

Policy statements

Under this interim policy and in accordance with good clinical practices, Health Canada will apply the following interpretations.

1. Research ethics board for multi-site trials

Sponsors of multi-site trials sometimes identify the same research ethics board for all clinical trial sites if they operate within a streamlined multi-site ethics review process.

Several initiatives and organizations have facilitated more streamlined ethics review systems in Canada, such as:

BC Ethics Harmonization Initiative (BCEHI)
Canadian Collaboration for Child Health: Efficiency and Excellence in the Ethics Review of Research (CHEER)
CanReview, Canada's single research ethics review system
CATALIS, Quebec's fast track evaluation service
Clinical Trials Ontario's streamlined ethical review
Maritime SPOR SUPPORT Unit (MSSU)
Nova Scotia Health Research Ethics Board
Ontario Cancer Research Ethics Board (OCREB)
REB Exchange Alberta (REBX)
Research improvements through harmonization in Manitoba (RITHIM)

Providing information to Health Canada

When providing information on a new site through the Clinical Trial Site Information form, you only need to include the contact information for a research ethics board once, as long as:
- the same board has previously been identified as having approved other sites in that trial
- the board's contact information has already been provided to Health Canada in the context of this clinical trial, and continues to be up to date
Accordingly, the form's section on research ethics board approval may only contain the name of the approving board and the date of its approval.
Documentation and record keeping

As a sponsor, you're responsible for obtaining and retaining records for all research ethics board approvals that may be required for participating sites, in accordance with applicable local requirements. You must retain records of all approvals for verification during clinical trial inspections.

To meet our requirements, you must maintain complete and accurate records demonstrating research ethics board approval for research undertaken at a clinical trial site.

2. Qualification requirements of a "qualified investigator"

Under this interim policy, a "qualified investigator" may be:

a physician or dentist who is authorized under the Food and Drug Regulations to act as a qualified investigator
an individual who has the education, training and experience required to conduct the clinical trial in accordance with regulatory requirements, despite not meeting the requirement to be a physician or dentist as outlined in the definition of "qualified investigator" in C.05.001

In clinical trials where the investigator is not a physician or dentist, medical decisions with respect to the trial that are outside the licensed scope of practice of the investigator must be made by a qualified physician or dentist on the clinical trial team who is:

licensed to practice in the province or territory where the site is located
responsible for medical oversight and participant care, including medical decisions in respect of the trial

This allows broader range of researchers to serve as investigators where:

medical care is assured by a physician or a dentist
the researcher's training, expertise, and scope of practice are appropriate to the clinical trial

3. Documented informed consent

Under this interim policy, informed consent requirements will be considered met where processes:

are appropriately documented
comply with good clinical practices and ICH E6 principles
ensure that consent is informed and given in accordance with the applicable laws governing consent

Moving from "written" to "documented" informed consent allows for new approaches for obtaining consent, such as:

remote or electronic platforms that enable real-time, interactive consent discussions conducted using audio and video technologies
electronic signatures and documentation of consent where it is provided orally, either in person or remotely

Interpretation

This interim policy does not alter a sponsor's responsibility to ensure that clinical trials are conducted in accordance with good clinical practices and all applicable ethical, legal and institutional requirements.

Sponsors remain responsible for ensuring that:

you obtain valid research ethics board approval for all participating clinical trial sites before commencing activities at that site
- You must obtain approval in accordance with applicable institutional and legal requirements (including any relevant provincial or territorial requirements)
investigators meet applicable requirements and are appropriately qualified to conduct the clinical trial
a qualified physician or dentist supervises medical care and medical decisions (in respect of the trial) at each clinical trial site
you obtain and document consent in a manner that ensures it is informed and given in accordance with applicable laws governing consent

This interim policy is aligned with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. The statement stipulates that institutions remain responsible for the ethical acceptability and ethical conduct of research undertaken under their auspices. All stakeholders should refer to the ICH Harmonised Guideline for Good Clinical Practice for guidance on their roles and responsibilities.

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Clinical trial inspections

As part of record-keeping requirements, sponsors must continue to ensure that:

documentation related to research ethics board approvals to conduct clinical trial activities at each participating site is available for Health Canada inspectors to verify
you remain responsible for each clinical trial site by having an attestation, signed and dated by a research ethics board, stating that:
- it has reviewed and approved the protocol and informed consent form for that clinical trial site
- the board carries out its functions in a manner consistent with good clinical practices
documents and records related to the educational and professional qualifications and competencies of members of the clinical trial team are available for verification by Health Canada inspectors
you appropriately document consent processes and retain records for verification by Health Canada inspectors

Contact

Prescription Drugs Directorate, Health Products and Food Branch
Office of Clinical Trials
Email: oct.enquiries-requetes.bec@hc-sc.gc.ca
Telephone: 613-941-2132

Bureau of Policy, Science and International Programs
Email: policy_bureau_enquiries@hc-sc.gc.ca

Biologic and Radiopharmaceutical Drugs Directorate
Email: brdd.ora@hc-sc.gc.ca

Regulatory Operations and Enforcement Branch (Inspections)
Email: GCP.BPC@hc-sc.gc.ca

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2026-09-14