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

C.03.313. (1) On the Minister’s written request, a sponsor shall submit, within the period specified in the request, information to establish the safety of the study drug if the Minister has reason to believe any of the following:

• (a) the use of the study drug may endanger the health of a study subject or other person;

• (b) the study may be contrary to the best interests of the study subjects;

• (c) a qualified investigator is not respecting their undertaking made under paragraph C.03.315(3)(f); or

• (d) information submitted in respect of the study drug or study is false or misleading.

(2) The Minister may, by notice in writing, require the sponsor to provide the Minister with any information or records referred to in subsection C.03.315(3) to assess the safety of the study drug or the health of the study subjects or other persons, by the date specified in the notice.

C.03.314. (1) During the course of a study, the sponsor shall notify the Minister of any serious adverse reaction or serious unexpected adverse reaction that occurs inside or outside Canada, within the following period:

• (a) if the adverse reaction is fatal or life-threatening, within seven days after becoming aware of it; or

• (b) if the adverse reaction is not fatal or life-threatening, within 15 days after becoming aware of it.

(2) The sponsor shall, within eight days after having notified the Minister under subsection (1), file with the Minister a complete report in respect of the adverse reaction, including an assessment of the importance and implication of the findings.

(3) Sections C.01.016 to C.01.020 do not apply to study drugs.

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;

• (b) written procedures for subject monitoring and for the documentation and reporting of adverse reactions;

• (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.