ASK JEAN: Medical responsibility in clinical trials
28 October 2019
Who has medical responsibility of a Clinical Trial in Canada? Here are the top three frequently asked questions on this topic.
- Who can be a Qualified Investigator in Canada?
In Canada, the Food and Drug Regulations establish that, at a minimum, an investigator must be a physician in good standing with her/his medical association and who is licensed to practice in the province where the site is located[i].
C.05.001 qualified investigator means the person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where that clinical trial site is located, and who is(a) in the case of a clinical trial 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; and(b) in any other case, a physician and a member in good standing of a professional medical association.
- Can you have a Co-Investigator at a site in a Clinical Trial in Canada?
No. There is no such thing as a Co-Investigator at a Clinical Trial Site in Canada. There can only be one qualified investigator at each site.[ii] You can have a Sub-investigator who is a medical physician who can be delegated some of the medical responsibilities. Some registration and ethics databases use the term Co-Investigator and have fields that should not be filled for a regulated phase 1 to 4 Clinical Trial in Canada.
C.05.010 Every sponsor shall ensure that a clinical trial is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, shall ensure that
(e) at each clinical trial site, there is no more than one qualified investigator;
(f) at each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the qualified investigator;
(g) each individual involved in the conduct of the clinical trial is qualified by education, training and experience to perform his or her respective tasks
- Can a Nurse Practitioner, Midwife or Podiatrist be a Qualified Investigator or sub- investigator in Canada?
No. Licensed Canadian health professionals such as nurse practitioners, midwives, podiatrists can prescribe drugs and write orders in some provinces. Some of these professionals have training and experience to be delegated some medical responsibilities by a qualified investigator of a drug clinical trial.[iii] Legally however, they do not have the authority to be a qualified investigator or a sub-investigator under the Canadian Food and Drug Regulations.
Practitioners may be delegated responsibilities in keeping with the professional scope of practice in the jurisdiction to which they are licensed – only. That is a fine point which is significant. To summarize, if you are a physician’s assistant licensed in a province in Canada, it does not mean you can be a qualified investigator (QI) or ‘principal investigator’ (not a Canadian term) in Canada on a Clinical Trial filed with another regulatory authority.
[i] Health Canada, Food and Drug Regulations, C.R.C. c.870, C.05.001 “Qualified Investigator”
[ii] Health Canada, Food and Drug Regulations, C.R.C. c.870, C.05.010 “Sponsor Responsibilities”
[iii] Health Canada, Regulatory Operations and Enforcement Branch (ROEB), Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100) – Summary. August 20, 2019