Sponsors
A Sponsor of a clinical trial is usually: 1) a company, such as a pharmaceutical company, which has developed the drug, medical device, or natural health product; or an academic institution with a researcher acting as the Sponsor-Investigator or as the Qualified Investigator with the university acting as a Sponsor.
Guidance for clinical trial Sponsors is available through Health Canada. All clinical researchers must be familiar with the details of the Regulations Amending the Food and Drug Regulations. These regulations apply to clinical trials for both new, investigational, drugs and some marketed drugs.
Clinical Trial Applications
The Sponsor submits a Clinical Trial Application (CTA) to Health Canada. The Clinical Trial Application (CTA) must be filed with Health Canada prior to the initiation of a clinical trial in Canada.
The Health Canada application includes:
- a protocol which details the objectives, benefits, risks, methods, and conditions for the trial to function
- Clinical Trial Site Information Form
- Clinical Trial Application (CTA)
- Qualified Investigator Undertaking
- Research Ethics Board Attestation (if available at the time of submission)
Qualified Investigator
There must be a qualified investigator (QI) for Phase I, II, and III clinical trials involving a drug or natural health product as defined under the regulation. The QI is responsible to the sponsor for the conduct of the clinical trial at the trial site and is entitled to provide health care under the laws of the province where the clinical trial site is located.
For a clinical trial involving a drug, the QI is:
- a physician and member in good standing of a professional medical association, or
- in the case of clinical trials respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association.
The Qualified Investigator must sign an undertaking that he/she will conduct the trial according to Good Clinical Practices.
Requirements and Review Process
Clinical Trial Application requirements are outlined in the Food and Drugs Act and Regulations, the Guidance for Clinical Trial Sponsors: Clinical Trial Applications document and the Clinical Trial Application form. These documents also explain the requirements pertaining to local Research Ethics Board review and approval of clinical trials.
Health Canada normally reviews the application and notifies the Sponsor within 30 days if the application is found to be deficient.
All Health Canada application documents and approvals must be uploaded into ROMEO where VIU researchers are involved.
Institutional/Investigator-initiated CTAs must comply with the same regulatory requirements that apply to Industry-initiated CTAs, with some modifications as outlined in the Guidance for Clinical Trial Sponsors: Clinical Trial Applications document referenced above.
If there is any uncertainty as to whether Health Canada approval is required, the researcher should contact Health Canada
Record-keeping
- Health Canada requires that all clinical trial records be maintained for a period of 25 years.
- Documentation must include a Research Ethics Board Attestation that “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.” A “Research Ethics Board Attestation” form is available at the above website for this purpose.
Standard Operating Procedures
- The Sponsor and the researcher are responsible for meeting the mandatory requirement that outlines the procedures followed during the conduct of a clinical trial to ensure compliance to GCP, applicable regulations and research ethics requirements. Procedures are defined in standard operating procedures (SOPs) which are version-controlled documents. SOPs and training must be documented for all study team members on current versions and updates before starting a trial.
- SOP templates for all elements of trial conduct are available from N2 Network of Networks (see resources). Guidance documents can also be created to ensure the quality, compliance and consistency of study conduct.
More detailed information is provided in Health Canada’s Guidance for Clinical Trial Sponsors: Clinical Trial Applications document.
After Review and Prior to Initiating the Study
Once the CTA is approved, Health Canada will issue a No Objection Letter that has to be provided to the REB as part of the submission for review and approval of the study. When the study has received ethics clearance through a Research Ethics Board (REB), the clinical trial can begin under the supervision of the REB. The Sponsor, Qualified Investigators, and REBs oversee the operation of the clinical trial. Health Canada's role is with respect to (i) the approval of the drug and related clinical trial or issuing a "No Objection Letter" for a medical device Class II or higher and (ii) monitoring of drug clinical trials. The Qualified Investigator is responsible for the medical care of participants at all times during the trial.
Clinical Trial Inspections
Clinical trials in Canada for human drugs must meet high safety standards. Health Canada inspects clinical trials to reduce the risks to people participating in the trials. To learn more about the clinical trial inspection process, please visit about clinical trial inspections.
Find more information about Guidance for VIU Researchers Interested in Conducting Clinical Research, Clinical Trials or Studies Involving a Drug, Medical Device, or Natural Health Product, and Resources to Support BC Researchers.