Food and Drug Regulations (C.R.C., c. 870)

C.05.009. If the information and documents submitted in respect of an application under section C.05.005 or an application for amendment under section C.05.008 are insufficient to enable the Minister to determine whether any of the reasons referred to in paragraph C.05.006(1)(b) or C.05.008(1)(b) exist, the Minister may require the sponsor to submit, within two days after receipt of the request, samples of the drug or additional information relevant to the drug or the clinical trial that are necessary to make the determination.

C.05.010. Every sponsor shall ensure that a clinical trial is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, shall ensure that

• (a) the clinical trial is scientifically sound and clearly described in a protocol;

• (b) the clinical trial is conducted, and the drug is used, in accordance with the protocol and this Division;

• (c) systems and procedures that assure the quality of every aspect of the clinical trial are implemented;

• (d) for each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins at the site;

• (e) at each clinical trial site, there is no more than one qualified investigator;

• (f) at each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the qualified investigator;

• (g) each individual involved in the conduct of the clinical trial is qualified by education, training and experience to perform his or her respective tasks;

• (h) written informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before that person participates in the clinical trial but only after that person has been informed of

  • (i) the risks and anticipated benefits to his or her health arising from participation in the clinical trial, and

  • (ii) all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial;

• (i) the requirements respecting information and records set out in section C.05.012 are met; and

• (j) the drug is manufactured, handled and stored in accordance with the applicable good manufacturing practices referred to in Divisions 2 to 4 except sections C.02.019, C.02.025 and C.02.026.

C.05.011. Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the drug bears a label that sets out the following information in both official languages:

• (a) a statement indicating that the drug is an investigational drug to be used only by a qualified investigator;

• (b) the name, number or identifying mark of the drug;

• (c) the expiration date of the drug;

• (d) the recommended storage conditions for the drug;

• (e) the lot number of the drug;

• (f) the name and address of the sponsor;

• (g) the protocol code or identification; and

• (h) if the drug is a radiopharmaceutical as defined in section C.03.201, the information required by subparagraph C.03.202(1)(b)(vi).