Draft guidance on the registration of clinical trials and public disclosure of results: Health Canada Clinical Trials Portal

On this page

• About the portal
• Data sources and fields
• Missing registry information

About the portal

Health Canada's Clinical Trials Portal displays information about authorized Canadian drug trials, including:

• biologics
• pharmaceuticals
• radiopharmaceuticals

Subsequent releases of the portal under a phased implementation strategy are planned. They will include information for all authorized Canadian clinical trials investigating:

• medical devices
• NHPs
• prescribed FSDPs, once they are permitted by regulation

Sponsors of trials for all product lines (this means drugs, medical devices and NHPs) are encouraged to follow the registration and reporting steps outlined in this guidance document in anticipation of subsequent releases of the portal.

Data sources and fields

The portal contains information about Health Canada-authorized trials from 3 data sources:

1. Information provided to Health Canada in support of a clinical trial application, after the application is authorized
2. Information Health Canada will extract from the WHO ICTRP
3. Information Health Canada will extract directly from registries that comply with WHO standards

Users of the portal will have access to information about authorized Canadian trials. Through evolution and subsequent phases of the portal, the information reflected may change over time. The information contained on the portal includes:

• details about the trial and product being investigated
• a link to the record for the trial in either the WHO ICTRP or the registry where the trial was registered by the sponsor

Missing registry information

At the time of initial publication of an authorized clinical trial on the portal, certain information may not be available until:

1. the sponsor has registered the trial with an international registry
2. Health Canada has extracted the trial record

Trials that opened before implementation of this policy may include more limited information.

If an authorized trial has opened and Health Canada has not been able to find a record of registration from the WHO ICTRP or a registry, the portal will state "Not currently listed in registry", or a similar statement.