Guidance on expanded access clinical trials: Glossary

Definitions specific to this guidance

Expanded access clinical trial:

A type of clinical trial that provides access to investigational drugs that have the potential to treat people living with medical conditions who do not qualify for other clinical trials or are not able to participate in one.

Investigational drugs:

Pharmaceutical, biologic, and radiopharmaceutical drugs for human use that are tested or studied in a clinical trial.

Definitions adapted from the Food and Drug Regulations

Note: These definitions are subject to change should the definitions change in the Food and Drug Regulations.

Adverse events:

Any adverse occurrence in the health of a clinical trial participant who is administered a drug, that may or may not be caused by the administration of the drug, and includes an adverse drug reaction.

Good clinical practices:

Generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trial participants and other persons, and the good clinical practices referred to in section C.05.010.

Investigator's brochure:

A document containing the preclinical and clinical data on the drug.

Protocol:

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

Qualified investigator:

Person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where that clinical trial is located.

Research ethics board:

A body not affiliated with the sponsor (made up of researchers, people with specific expertise, and community members), and whose principal mandate is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human participants in order to ensure the protection of their rights, safety and well-being.

Sponsor(s):

An individual, corporate body, institution or organization that conducts a clinical trial.

Definitions taken from other Health Canada (HC) sources

Placebo:

A control treatment that does not contain the medicinal ingredient that is given to a group of trial participants. (Taken from Clinical Trials Database definitions.)

Real-world data:

data relating to patient status and/or the delivery of health care routinely collected from a variety of sources. (Taken from HC publication on elements of real-world data/evidence quality throughout the prescription drug product life cycle.)

Real-world evidence:

evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of real-world data. (Taken from HC publication on elements of real-world data/evidence quality throughout the prescription drug product life cycle.)