C.05.012. (1) The sponsor shall record, handle and store all information in respect of a clinical trial in a way that allows its complete and accurate reporting as well as its interpretation and verification.
(2) The sponsor shall maintain complete and accurate records to establish that the clinical trial is conducted in accordance with good clinical practices and these Regulations.
(3) The sponsor shall maintain complete and accurate records in respect of the use of a drug in a clinical trial, including
(a) a copy of all versions of the investigator’s brochure for the drug;
(b) records respecting each change made to the investigator’s brochure, including the rationale for each change and documentation that supports each change;
(c) records respecting all adverse events in respect of the drug that have occurred inside or outside Canada, including information that specifies the indication for use and the dosage form of the drug at the time of the adverse event;
(d) records respecting the enrolment of clinical trial subjects, including information sufficient to enable all clinical trial subjects to be identified and contacted in the event that the sale of the drug may endanger the health of the clinical trial subjects or other persons;
(e) records respecting the shipment, receipt, disposition, return and destruction of the drug;
(f) for each clinical trial site, an undertaking from the qualified investigator that is signed and dated by the qualified investigator prior to the commencement of his or her responsibilities in respect of the clinical trial, that states that
(i) the qualified investigator will conduct the clinical trial in accordance with good clinical practices, and
(ii) the qualified investigator will immediately, on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, inform both the clinical trial 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 clinical trial subjects or other persons;
(g) for each clinical trial site, a copy of the protocol, informed consent form and any amendment to the protocol or informed consent form that have been approved by the research ethics board for that clinical trial site; and
(h) for each clinical trial site, an attestation, signed and dated by the research ethics board for that clinical trial site, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner consistent with good clinical practices.
(4) The sponsor shall maintain all records referred to in this Division for a period of 25 years.
- SOR/2001-203, s. 4.
Submission of Information and Samples
C.05.013. (1) The Minister shall require a sponsor to submit, within two days after receipt of the request, information concerning the drug or the clinical trial, or samples of the drug, if the Minister has reasonable grounds to believe that
(a) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person;
(b) the clinical trial is contrary to the best interests of a clinical trial subject;
(c) the objectives of the clinical trial will not be achieved;
(d) a qualified investigator is not respecting the undertaking referred to in paragraph C.05.012(3)(f); or
(e) information submitted in respect of the drug or the clinical trial is false or misleading.
(2) The Minister may require the sponsor to submit, within seven days after receipt of the request, any information or records kept under section C.05.012, or samples of the drug, in order to assess the safety of the drug or the health of clinical trial subjects or other persons.
- SOR/2001-203, s. 4;
- SOR/2012-16, s. 9(F).
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