Guidance on the registration of clinical trials and public disclosure of results: Registration

Introduction

Health Canada's policy expectations for registration and reporting of summary results involve the use of WHO acceptable registries. Use of these international registries ensures harmonization of data collection and strengthens the validity of the scientific evidence base.

Find information about the WHO international standards and criteria.

For multi-national clinical trials with 1 or more Canadian sites, sponsors should follow the scope and policy expectations described in this guidance document, even if a clinical trial is subject to regulation in other countries. In working with the registry during the registration process and while keeping a clinical trial record up to date, sponsors should be aware of any relevant regulations, guidance documents or other regional requirements.

When to register

Sponsors are expected to register their clinical trial ideally before it has opened for enrolment in Canada but no later than 21 calendar days after the date of enrolment of the first participant. Health Canada considers the registration date as the date when the clinical trial registration materials are first submitted to a registry.

For a multi-national clinical trial with 1 or more Canadian sites, sponsors are expected to add the Canadian site(s) to their existing registry record. Ideally, this should be done before opening for enrolment but no later than 21 calendar days after the date of enrolment of the first participant at the Canadian site(s). All Canadian trial sites should be listed clearly.

Note that registration in an international registry does not change Health Canada's applicable regulatory requirements for clinical trial applications. This includes a completed Clinical Trial Site Information Form for each proposed clinical trial site.

Learn about the requirements related to conducting clinical trials in Canada.

Where to register

Health Canada does not maintain a Canadian registry for clinical trials. Sponsors are expected to register their clinical trial with an international clinical trial registry that complies with WHO international standards.

This includes data providers accepted by the WHO International Clinical Trials Registry Platform (ICTRP) that create and manage trial records in a manner that is consistent with the WHO Registry Criteria.

Learn more:

Registries accepting Canadian trials

Two widely used registries that are publicly accessible and part of the WHO ICTRP Network are:

ISRCTN in the United Kingdom
ClinicalTrials.gov in the United States

Both registries:

can be searched free of charge
collect and display the WHO Registration Data Set for clinical trials
accept prospective registration of clinical trials taking place in all countries

These registries accept clinical trials that:

are conducted in Canada
investigate all product lines within the scope of this policy (drugs, medical devices and NHPs)

Not all registries and data providers that comply with WHO international standards will accept clinical trials conducted in Canada.

How to register

Health Canada does not have a role in the registration processes of clinical trial registries.

When a sponsor submits information about their clinical trial to any registry, registry staff will review that information before it is published. This review helps to ensure that the information is clear, informative and conforms to the specifications of the registry, including the minimum amount of information to be submitted in accordance with the WHO standards. The sponsor may be asked by registry staff to clarify items or make corrections before publication.

The length of the review process could vary, depending on the preparedness of the sponsor and quality of the clinical trial record.

Once the clinical trial information is accepted by registry staff for publication, it is posted on the registry for public viewing.

Protocol code

Sponsors should include the protocol code (referred to as protocol number in the regulations) in their registry record. Protocol codes are generated by the sponsor and are also submitted to Health Canada as part of a clinical trial application. The protocol code is a variable length, alpha-numeric sequence used by sponsors to assign a reference identifier to their clinical trial or investigational testing protocol.

All registries that comply with WHO international standards are able to include other study ID numbers known as secondary identifying numbers as part of their data set. Health Canada recommends including the protocol code as one of the secondary identifying numbers in the registry. This will allow us to locate matching registry records for Health Canada-authorized trials. We aim to reduce burden on sponsors by extracting and publishing select data from registry records and providing weblinks on the search portal.

Sponsors should ensure that their protocol code is entered in the exact same format in both the registry and the clinical trial application to Health Canada, including characters such as hyphens and underscores.

Controlled vocabularies

Sponsors should be aware of any requirements of their chosen registry regarding the use of a controlled vocabulary thesaurus for clinical terminology. Where feasible, Health Canada recommends using one of the following:

Medical Dictionary for Regulatory Activities (MedDRA)
Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT)

Sponsors should use the same controlled vocabularies for the registry and their clinical trial application submission to Health Canada.

Learn about the Clinical trials portal.

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2026-07-28