Part C, Division 5 of the Food and Drug Regulations "Drugs for Clinical Trials Involving Human Subjects" (GUI-0100): Submission of information and samples
Submission of information and samples
C.05.013
- 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
- the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person;
- the clinical trial is contrary to the best interests of a clinical trial subject;
- the objectives of the clinical trial will not be achieved;
- a qualified investigator is not respecting the undertaking referred to in paragraph C.05.012(3)(f); or
- information submitted in respect of the drug or the clinical trial is false or misleading.
- 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.
Interpretation
Health Canada may request that a sponsor submit either information or samples of a study drug if the information and documents submitted are insufficient to assess the quality and safety of the drug to be used in the clinical trial. The sponsor must provide the information requested, within 2 calendar days of that request, should Health Canada have reasonable grounds to believe that:
- the use of the drug endangers the health and safety of a participant or other person
- the trial is not in the best interests of a clinical trial participant
- the objectives of the trial will not be achieved
- the QI is not respecting the undertaking (QIU form) described in C.05.012(3)(f), or
- information submitted in respect of the drug or the clinical trial is thought to be false or misleading
Furthermore, Health Canada may request that a sponsor submit information or records described in C.05.012, or samples of the drug, within 7 calendar days of the request, in order to assess the safety of the drug or the health of any of the clinical trial participants or other persons.
Retention samples of the drug
Although the Regulations do not specifically state that samples of clinical trial drugs must be kept, in order to be able to fulfill Health Canada's request for a sample, as specified in this section, it is implicit that retention samples should be kept from the start of a clinical trial until the clinical trial report has been prepared.
Retention of biological study samples
The Regulations do not cover biological study samples and do not specify how long they should be kept. If the sponsor chooses to maintain biological study samples (for example serum samples), Health Canada recommends that they be kept until the clinical trial report has been prepared to enable confirmation of results, specifically in the event of inconsistent results.
An example inspection observation typically cited under this section of the Regulations includes:
- The sponsor did not submit the requested information concerning the drug or the clinical trial, and/or requested samples of the drug, within the required time frame