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• C.03.315 (1) The sponsor shall record, handle and store all information in respect of a study in a way that allows it to be reported completely and accurately and to be interpreted and verified.

• (2) The sponsor shall maintain complete and accurate records to establish that the study is conducted in accordance with these Regulations.

• (3) The sponsor shall maintain all of the following records in respect of the use of the study drug in each study:

  • (a) records respecting all adverse reactions that occur inside or outside Canada, including the indications for use and the dosage form of the study drug at the time of the adverse reaction;

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  • (c) articles from scientific journals or other publications that were used in support of the safety profile of the study drug in respect of humans;

  • (d) records in respect of each study subject, including respecting their enrolment, a copy of their signed consent form and sufficient information to enable them to be identified and contacted in the event that the sale of the study drug may endanger their health or that of another person;

  • (e) records respecting the shipment, receipt, sale, return and destruction or other disposition of the study drug;

  • (f) for each study site, an undertaking, dated and signed by the qualified investigator before the start of the study, that they will

    • (i) conduct the study in accordance with good clinical practices, and

    • (ii) on discontinuance of the study by the sponsor, for any reason related to health or safety, immediately inform both the study subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them in writing of any potential risks to the health of study subjects or other persons;

  • (g) for each study site, a copy of the informed consent form; and

  • (h) for each study site, a copy of the certifying statement described in paragraph C.03.307(2)(q), of the protocol for the study and of the statement of the risks and anticipated benefits arising to the health of study subjects as a result of participating in the study that is set out in the informed consent form.

• (4) The sponsor shall maintain all records for five years after the day on which the study ends.

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C.03.311 A sponsor shall ensure that each study is conducted in accordance with good clinical practices and that

• (a) the study is scientifically sound and clearly described in its protocol;

• (b) the study is conducted, and the study drug is used, in accordance with the protocol and with these Regulations;

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

• (d) at each study site, there is only one qualified investigator;

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

• (f) each individual who is involved in the conduct of the study is qualified by their education, training and experience to perform their respective tasks;

• (g) before a study subject participates in the study, a copy of their signed consent form is included in the records for the study;

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• (i) the study drug is manufactured, handled and stored in accordance with Division 2, other than sections C.02.019, C.02.025 and C.02.026.

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• C.03.307 (1) The sponsor shall submit to the Minister an application for authorization to sell or import a study drug that contains the information set out in subsection (2) as well as sufficient information to demonstrate that all of the following criteria are met:

  • (a) the use of the study drug will not endanger the health of any study subject or other person;

  • (b) the study is not contrary to the best interests of the study subjects; and

  • (c) the objectives of the study can reasonably be achieved.

• (2) The application shall contain all of the following information:

  • (a) the title of the study and the protocol code or identification;

  • (b) the purposes and a concise description of the study;

  • (c) the number of study subjects;

  • (d) the brand name, if any, of the study drug;

  • (e) the chemical or generic name of the active ingredients in the study drug;

  • (f) a qualitative list of the non-active ingredients of the study drug;

  • (g) the maximum mass of the study drug to be administered to each study subject;

  • (h) the radioactive dose range of the study drug, expressed in MBq or mCi;

  • (i) the effective dose or effective dose equivalent of the study drug, expressed in mSv/MBq or rem/mCi;

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  • (l) in the case of an application for importation, the name and civic address, the postal address if different, and the telephone number, fax number and email address of the manufacturer’s representative in Canada who is responsible for the sale of the study drug;

  • (m) the name and civic address of each study site;

  • (n) for each study site, the name, civic address, telephone number, fax number and email address of the qualified investigator;

  • (o) the proposed starting date for the study at each study site, if known;

  • (p) for each study site, the name, civic address, telephone number, fax number and email address of the research ethics board;

  • (q) a statement, dated and signed by the research ethics board for each study site, that certifies that it has reviewed and approved the study, the protocol and the statement of the risks and anticipated benefits arising to the health of study subjects as a result of participating in the study that is set out in the informed consent form;

  • (r) a list of any previous applications for an authorization to sell or import a drug for a study related to the current study; and

  • (s) a statement, dated and signed by the sponsor’s senior medical or scientific officer in Canada and senior executive officer, that certifies both of the following:

    • (i) the study will be conducted in accordance with these Regulations, and

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• C.03.305 (1) A study shall meet all of the following requirements:

  • (a) before the study drug is used in the study, there is sufficient data from testing it in animals and humans to demonstrate its safety in humans;

  • (b) the amount of active ingredients or combination of active ingredients in the study drug has been shown not to cause any clinically detectable pharmacodynamic effect in humans;

  • (c) the total radiation dose incurred annually by a study subject, including from multiple administrations of the study drug, from significant contaminants or from impurities and from the use of other procedures for the purposes of the study, will be not more than 50 mSv;

  • (d) any concomitant drug used in the study has been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a concomitant drug that is a new drug, has been issued a notice of compliance under section C.08.004;

  • (e) study subjects shall be at least 18 years old and have legal capacity at the time of the study;

  • (f) female study subjects shall

    • (i) be confirmed at the outset of the study, on the basis of a pregnancy test, as not being pregnant or state in writing that they are not pregnant, and

    • (ii) be advised that if they are lactating, they are to suspend lactation for 24 hours after the administration of the study drug; and

  • (g) the study shall not involve more than 30 study subjects.

• (2) Despite paragraph (1)(g), a study may involve more than 30 study subjects if the sponsor provides the Minister with a scientific rationale for the increase and the Minister approves it.

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C.03.301 The following definitions apply in this section and in sections C.03.302 to C.03.319.

adverse reaction

adverse reaction  means an undesirable and unintended response in a study subject or other person to a study drug that is caused by the administration of any dose of the study drug. (réaction indésirable)

good clinical practices

good clinical practices  means generally accepted clinical practices that are designed to protect the rights, safety and well-being of study subjects and other persons. (bonnes pratiques cliniques)

import

import  means, in respect of a study drug, to import it into Canada for sale for the purpose of a study. (importer)

other person

other person  means an individual who comes into physical contact with a study subject. (autre personne)

protocol

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

qualified investigator

qualified investigator  means the physician and member in good standing of a professional medical association in Canada to whom a sponsor gives the responsibility for the proper conduct of the study at a given study site, who is entitled to practise their profession under the laws of the province where the study site is located. (chercheur qualifié)

serious adverse reaction

serious adverse reaction  means an adverse reaction that results in any of the following consequences for the study subject or other person:

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serious unexpected adverse reaction

serious unexpected adverse reaction  means a serious adverse reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the study drug. (réaction indésirable grave et imprévue)

sponsor

sponsor  means a person who is responsible for the conduct of a study. (promoteur)

study

study means a basic clinical research study that involves human subjects and that is described in sections C.03.304 and C.03.305. (étude)

study drug

study drug  means a positron-emitting radiopharmaceutical that is used in a study. (drogue destinée à l’étude)

study site

study site  means the location where all or part of a study is conducted. (lieu d’étude)

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