Food and Drug Regulations

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.