Canada's search portal for clinical trials: Definitions, contact us

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Definitions

Authorized clinical trial:

A clinical trial that has been determined to meet Health Canada’s regulatory requirements. For drug clinical trials, this means that a no objection letter or an authorization has been issued. The date of this authorization is used as the “approved” date on the Canadian clinical trial search portal.

Clinical trial:

A study involving human subjects for the purpose of discovering or verifying the effects of a drug, a device or a food for a special dietary purpose. (Food and Drugs Act, or FDA)

Although this is the regulatory definition, for our purposes we use the term “participants” instead of “subjects”. Also note that pharmaceuticals, biologics, radiopharmaceuticals and natural health products are all considered drugs under the FDA and its regulations.

Refer to the About the portal section for a description of which clinical trials are included in the search portal.

Control number:

A unique 6-digit identification number Health Canada assigns to each clinical trial application.

Eligibility criteria:

The characteristics people must have or the requirements they must meet to participate in a clinical trial. Eligibility criteria include both inclusion criteria (must have for a person to participate) and exclusion criteria (prevent a person from participating). More detailed information should be reviewed before making a decision to participate.

The following elements are available on the portal:

• Sex:
  An eligibility factor based on biological characteristics. This value will default to “all” when no specific data is available. This variable is not intended to reflect the spectrum of human diversity. The portal filters may include:
  • all
  • male
  • female
• Age:
  The age a person must be to participate in the clinical trial. The age groups used in the filters are:
  • children (birth to 17 years)
  • adults (18 to 64 years)
  • older adults (65 years and over)
• Accepts healthy volunteers:
  People who do not have the disease or condition can participate in the clinical trial.

External registry link:

A weblink that takes users to an international registry that contains additional information about a trial.

• ClinicalTrials.gov is a clinical trial registry and results data bank operated by the National Library of Medicine (NLM) in the United States.
• The World Health Organization’s International Clinical Trials Registry Platform (WHO ICTRP) provides a single point of access to all WHO acceptable registries. From there you may click on a weblink to go the registry.

Intervention or treatment:

Name given to the drug used in the clinical trial. This may be a code name, chemical name of the active ingredient, non-proprietary name or brand name.

Last updated:

The date of the most recent update for each trial record in the Canadian clinical trial search portal.

Medical condition:

The disease or condition that’s being studied in the clinical trial.

Official protocol title:

A concise description used by sponsors to characterize the clinical trial protocol. Within the search portal, it represents the trial that Health Canada reviewed and approved. It’s displayed as the second title within each record on the search results list and on the detailed record view for each trial. It’s  the only title available for unmatched trials.

Participants:

Patients or healthy volunteers who participate in a clinical trial.

Patients:

Individuals who have a medical condition. Does not include healthy volunteers.

Phases of drug trials:

The stage of a clinical trial, based on factors such as the objective of the trial and number of participants. Phase data displayed in the portal is taken from international registry data.

1. Phase 1 clinical trials test an experimental drug on a small group of people for the first time. These trials:
   • look at the drug's safety
   • find a safe dose range
   • see if there are any side effects
2. In Phase 2 clinical trials, the drug is given to a larger group of people (usually 100 or more) to:
   • gather data on how well the drug works to treat a disease or condition
   • check the drug's safety on a wider range of people
   • figure out the best dose
3. In Phase 3 clinical trials, the drug is given to even larger groups of people (usually 1,000 or more) to:
   • make sure it’s still effective
   • monitor side effects
   • compare it to commonly used treatments
   • collect information about the drug that will allow it to be used safely on the market
4. Phase 4 clinical trials take place after the drug is approved and on the market. Information is gathered on things like the best way to use a drug and the long-term benefits and risks. Trials in the portal have been reviewed and approved by Health Canada. A phase 4 value in the portal usually refers to its designation outside of Canada.

Placebo:

A control treatment with no active ingredients that’s given to a group of trial participants.

Protocol:

A document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial.

Protocol code (formerly protocol number):

An alpha-numeric sequence generated by the sponsor that can vary in length. Sponsors use the protocol code to assign a reference identifier to their clinical trial protocol.

Sponsor:

A clinical trial sponsor is an individual, corporate body, institution or organization that conducts a clinical trial. The sponsor is responsible for every aspect of the trial and ensures that the trial is carried out under good clinical practices at each site.

Study completion date:

The date when the last participant in the global study was examined or received an intervention or treatment, to collect final data for all outcome measures and adverse events. A common term used internationally is the last participant’s last visit. This is referred to as “date completed” on the clinical trial search portal. Note that the completion date may be actual or estimated, depending what was provided to the registry. Estimated completion dates may be in the past or future.

Trial status:

The search portal can reflect a trial status for the clinical trial as a whole and the status for each site. For matched trials, Health Canada uses information provided by the sponsor to an international clinical trial registry to determine status values for each clinical trial. Status values on the portal may include:

• Not yet recruiting: Participants are not yet being recruited or enrolled at any site.
• Recruiting: Participants are currently being recruited.
• Active, not recruiting: The clinical trial is ongoing but new participants are not currently being recruited or enrolled.
• On hold: The clinical trial has been temporarily stopped, but it may start again.
• Closed: The clinical trial has either ended normally and participants are no longer being examined or treated, or it has stopped early and will not start again.
• Unknown: The status of the clinical trial has not been verified in the registry in the last 2 years.
• No match, ongoing: No registry match found, but the trial may be ongoing. (Contact the sponsor for status information.)
• Other: No useful data found for trial status. (Contact the sponsor for status information.)

Note: Recruitment refers to the broad process of finding, educating and enrolling suitable participants for a clinical trial. Enrolled means that a potential candidate has agreed to participate in the trial and has completed the informed consent process.

Contact us

Contact us by mail or email if you have questions about the clinical trial search portal:

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
1600 Scott St
6th Fl, Holland Cross, Tower B
Ottawa ON  K1A 0K9
Mail stop 3106C
Email: ct.portal.team-equipe.portail.ec@hc-sc.gc.ca