About inspections of clinical trials for human drugs
Canada aims to reduce the risks to participants who enrol in clinical trials. Learn about clinical trial inspections and how we conduct them.
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Clinical trial inspections
We monitor clinical trials through inspections and other measures, such as reviewing applications for clinical trials and tracking adverse reactions.
Inspections are conducted to help ensure that the people or organizations conducting the clinical trials (sponsors) comply with the law. This means:
- the clinical trial's human volunteers (participants) are kept safe
- data is properly collected and recorded
We will suspend or cancel a clinical trial if a risk to the health and safety of Canadians is identified.
What is a clinical trial?
A clinical trial is a medical research study that uses participants to:
- build on current medical knowledge
- test different drug treatments
Clinical trials may:
- compare a new medical approach or product to
- another already in use
- a placebo with no active ingredients
- study an approach or product on its own
This research helps determine if the new approach or product:
- is safe and effective
- can be used by or sold to the public
What rules apply?
We regulate clinical trials of drugs under the Food and Drugs Act and the Food and Drug Regulations.
These laws allow us to:
- monitor the sale and importation of drugs used in clinical trials
- enforce good clinical practices
Sponsors must also respect the good clinical practices described in the International Conference on Harmonization (ICH) Guidance for Industry, Topic E6.
What are good clinical practices?
Good clinical practices are internationally accepted standards for designing, conducting, recording and reporting clinical trials involving humans.
These standards ensure that the:
- rights, safety and well-being of the participants in a clinical trial are protected
- clinical trial data is credible
Who is involved
Sponsor
A sponsor is:
- an individual, company, institution or organization that starts, manages or finances a clinical trial
- the regulated party responsible for meeting all rules and legal requirements
A clinical trial may be conducted in more than a single location, all managed by the same sponsor.
Qualified investigator
A qualified investigator is:
- responsible for conducting the clinical trial at the clinical trial site on behalf of the sponsor
- entitled to provide health care under the laws of the province where that clinical trial site is located
The qualified investigator must be a:
- doctor and member in good standing of a professional medical association
- dentist and member in good standing of a professional dental association (for a drug used only for dental purposes)
Contract research organization
A contract research organization is a person or organization hired by the sponsor to perform trial-related duties and functions.
The research organization may be commercial or academic in nature, or another type of organization.
Senior medical officer
A senior medical (or scientific) officer:
- is an individual in Canada
- acts as the Canadian signing authority for the sponsor, who may be based in another country
Research Ethics Board
A Research Ethics Board (REB) is a group that is not affiliated with the sponsor of a clinical trial. Before starting a clinical trial, a sponsor must obtain REB approval for each trial site. The REB's role is to ensure the protection of the rights, safety and well-being of participants in a clinical trial.
What inspectors look for
During an inspection, inspectors observe clinical trial activities and compare them with a set of standards and approved protocol.
A clinical trial may have multiple sites in different regions. However, the inspection focuses on a single site and activities at that point in time.
Inspectors determine whether a clinical trial complies with clinical trial standards as outlined in Canada's:
- Food and Drugs Act
- Food and Drug Regulations
- ICH Guidance for Industry, Topic E6
Inspectors carefully look for areas that do not meet good clinical practices, including:
- use of a drug
- proper record-keeping
- participant care and consent
- standard operating procedures
- reporting of problems, such as serious adverse events
In conducting inspections, the inspectors:
- make observations of risk based on Canadian law
- document their observations
- communicate their findings to the sponsor and the qualified investigator
Risk observations
An inspector records any deficiencies in the form of an observation. A deficiency is any activity that does not follow Canadian law.
Each observation is classified by level of risk. This informs the overall clinical trial rating.
Sometimes, it is possible for companies to correct observations during an inspection. If not, companies must take corrective actions after the inspection to address the observations.
We will suspend or cancel a clinical trial if a risk to the health and safety of Canadians is identified.
After a clinical trial inspection
After completing the inspection, the inspector creates a report documenting the:
- findings (observations)
- overall rating of the clinical trial site
An overall rating will be either compliant or non-compliant with the:
- Food and Drugs Act
- Food and Drug Regulations
The inspector issues the overall rating based on the number and risk level of the observations made.
Compliant rating
A compliant rating means the sponsor has shown that clinical trial activities comply with the law.
A trial site may receive a compliant rating even if observations have been identified. The sponsor will need to take corrective actions to address the observations.
Non-compliant rating
A non-compliant rating means the sponsor has not shown that clinical trial activities comply with the law. Immediate corrective action may be required.
In some cases, we may take measures to suspend or cancel authorization to conduct a clinical trial:
- in its entirety
- at a specific site
Ongoing follow-up
Sponsors must provide us with a written corrective action plan for any observations, with target dates for completion. We may conduct a follow-up inspection to make sure corrective actions have been taken.
We will suspend or cancel a clinical trial if a risk to the health and safety of Canadians is identified.
Inspection report cards
We recently launched a new searchable database that includes detailed inspection report cards:
Each inspection report card summarizes inspection observations and ratings.
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