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Canada – Division 5 – Drugs for Clinical Trials

Food and Drug Regulations

Part C: Drugs

DIVISION 5: DRUGS FOR CLINICAL TRIALS INVOLVING HUMAN SUBJECTS

Interpretation

C.05.001. The definitions in this section apply in this Division.

"adverse drug reaction" means any noxious and unintended response to a drug that is caused by the administration of any dose of the drug. (réaction indésirable à une drogue)

"adverse event" means any adverse occurrence in the health of a clinical trial subject who is administered a drug, that may or may not be caused by the administration of the drug, and includes an adverse drug reaction. (incident thérapeutique)

"clinical trial" means an investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug. (essai clinique)

"drug" means a drug for human use that is to be tested in a clinical trial. (drogue)

"good clinical practices" means generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trial subjects and other persons, and the good clinical practices referred to in section C.05.010. (bonnes pratiques cliniques)

"import" means to import a drug into Canada for the purpose of sale in a clinical trial. (importer)

"investigator's brochure" means, in respect of a drug, a document containing the preclinical and clinical data on the drug that are described in paragraph C.05.005(e). (brochure du chercheur)

"protocol" means a document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial. (protocole)

"qualified investigator" means the 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 site is located, and who is
(a) in the case of a clinical trial respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association; and

(b) in any other case, a physician and a member in good standing of a professional medical association. (chercheur qualifié)

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