Draft guidance on the registration of clinical trials and public disclosure of results: Registration

On this page

• WHO international standards and criteria
• When to register
• Where to register
• Protocol numbers
• Trial identification numbers
• Use of controlled vocabularies
• Registries accepting Canadian trials
• How to register a clinical trial

WHO international standards and criteria

Part of the WHO International Clinical Trials Registry Platform (WHO ICTRP) mission statement emphasizes: "The registration of all interventional trials is a scientific, ethical and moral responsibility".

The WHO ICTRP aims to encourage prospective registration of specific information (the WHO Trial Registration Data Set) for all clinical trials and assist with public access to that information.

The WHO ICTRP Registry Network allows information exchange and collaboration to establish best practices for clinical trial registration. This network includes:

• data providers
• partner registries
• primary registries
• registries working with the ICTRP towards becoming primary registries under its network

All must meet or be consistent with standards supporting criteria that fall under 6 main categories:

1. Content
2. Quality and validity
3. Accessibility
4. Unambiguous identification
5. Technical capacity
6. Administration and governance

As an example, under the content category, one criterion for primary registries is that they must be able to collect and publicly display the WHO Trial Registration Data Set for a trial to be considered fully registered.

Primary registries must attain the minimum standards for all criteria as described in the WHO ICTRP document titled "International Standards for Clinical Trial Registries". They must also meet the requirements set by the International Committee of Medical Journal Editors (ICMJE), such as:

• public access at no charge
• being open to all prospective registrants

The ICMJE policy recommends that medical journal editors require registration of clinical trials in a public registry at or before the time of patient enrollment as a condition of consideration for publication.

WHO trial registration data set (World Health Organization ICRTP)

Clinical Trials (International Committee of Medical Journal Editors)

International Clinical Trials Registry Platform (World Health Organization ICTRP)

When to register

Sponsors should register their Health Canada-authorized clinical trial before recruitment of the first participant (this means prospectively).

In alignment with existing international best practices, including standards of the WHO ICTRP, Health Canada recommends prospective registration. If a study authorized in Canada is already registered with trial sites in other countries, sponsors should add each Canadian site to their existing registration record before recruitment begins at that site. All Canadian trial sites should be listed clearly.

Where to register

Sponsors should register their Health Canada-authorized clinical trials with a clinical trial registry that complies with WHO international standards.

For the purpose of this guidance, this includes data providers accepted by the WHO ICTRP that create and manage trial records in a manner that is consistent with the WHO Registry Criteria. ClinicalTrials.gov is an example.

Registry criteria (World Health Organization ICTRP)

Eligible registries and data providers (World Health Organization ICTRP)

Protocol numbers

Along with a clear listing of Canadian trial site locations, sponsors should include the protocol number in the registry record. This is the same number that is submitted to Health Canada as part of a clinical trial application. The protocol number is a variable length, alpha-numeric sequence used by sponsors to assign a reference number to their clinical trial or investigational testing protocol.

All registries that comply with WHO international standards include "secondary identifying numbers" as part of their data set. Health Canada recommends submitting the protocol number as one of the secondary identifying numbers to assist with tracking and publication to the Health Canada CT Portal.

Trial identification numbers

A trial identification number is assigned by the registry to a particular clinical trial during the registration process. For example, ClinicalTrials.gov uses the trial identification number format of NCT12345678.

Health Canada will determine the appropriate process for sponsors to provide the trial identification number related to their authorized trial (sometimes called the registration number) to Health Canada. With this number, Health Canada is able to:

• augment information for publishing on the Health Canada CT Portal
• eliminate the need for sponsors to duplicate efforts in providing additional information to Health Canada

Use of controlled vocabularies

Follow the requirements of the registry including use of a controlled vocabulary thesaurus. Health Canada recommends using the:

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

Health Canada uses MedDRA to publish information on the CT Portal including the:

• names of the diseases or conditions studied in the clinical trial
• intervention types and names, where possible

The use of controlled vocabularies on the CT Portal enables more robust search functions. This helps to ensure that trials can be found among search results and that the search functions work in both official languages. This allows users of the CT Portal to more quickly find clinical trials that are relevant to their needs and can better facilitate the analysis of data derived from the CT Portal. Sponsors should use the same controlled vocabularies for the registry and their CTA submission to Health Canada.

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

They both accept clinical trials:

• conducted in Canada
• investigating 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 a clinical trial

Sponsors should comply with any standards or requirements of their chosen registry, including the information required to be submitted. Typical processes include a review of the clinical trial study record submitted by the sponsor by registry staff members before it is published. This helps to ensure that the information is clear, informative and conforms to the specifications of the registry. The sponsor may be asked by registry staff to clarify items or make corrections before publication. This review process could take a few days, depending on the preparedness of the sponsor and quality of the clinical trial record.

After the clinical trial record is submitted by the sponsor and accepted by review staff for publication, it would be made available on the registry for public viewing, generally within a few days.