I am conducting a clinical trial involving drugs and natural health products. What do I need to do?
I am not conducting a clinical trial but I am conducting a clinical study. Do I need to register the study?
There are compelling ethical reasons for registering your clinical study:
- improves researchers’ awareness of similar research so that they may avoid unnecessary duplication and reduce the burden on participants,
- improves researchers’ ability to identify potential collaborators and/or gaps in research so that they may pursue new avenues of inquiry with potential benefits to participants and to society,
- danger that some researchers or sponsors may only report research with favourable outcomes, and
- failure to report the outcome of a trial or withholding negative findings is more difficult when all research is registered.
Even if your clinical research does not perfectly fit the definition of a clinical trial you are encouraged to register your study for the reasons outlined above.
I am conducting a clinical trial involving drugs and natural health products. What do I need to do?
Research involving drugs and natural health products that are clinical trials as defined under the Food and Drug Regulations (Division 5: Drugs for Clinical Trials Involving Human Subjects) and Natural Health Products Regulations of the Canadian Food and Drug Act are regulated by Health Canada.
A clinical trial involving the testing of new drugs, medications, solutions, or natural heath products requires a clinical trial application to be approved by Health Canada.
The sponsor of the drug applies through the Therapeutic Products Directorate while the sponsor of a natural health product applies through the Natural Health Products Directorate.
I am working with an industry sponsor to conduct a study to test a medical device. What do I need to do?
Research involving the testing of a medical device is subject to regulations under the Medical Devices Bureau of Health Canada and requires an investigational testing authorization to be approved by Health Canada.
Research involving medical devices takes many forms such as a cardiac pacemaker, a hip implant, or contact lenses.
Devices include a wide range of instruments and are created to be used or represented for use in the prevention, diagnosis, mitigation, or treatment of a disease or abnormal physical condition or the restoration, correction or modification of body function or structure.
Researchers are responsible for knowing how these regulations affect the design and conduct of medical device and if an investigational testing authorization is required.
Medical device testing is a clinical study and in some situations may be defined as a clinical trial.
I have built a new device (or piece of equipment) that I would like to test on some human participants. What do I need to do?
Research involving the testing of a medical device is subject to regulations under the Medical Devices Bureau of Health Canada and requires an investigational testing authorization to be approved by Health Canada.
Product development which is not geared towards selling, distributing, or manufacturing the device is not subject to these regulations.
If you are fabricating a new device/equipment or modifying a commercially available device and want to test it on humans, an equipment and device safety review is required. This review is conducted by the Safety Office and you will need to allow two to three weeks for the review to take place.
A copy of the Safety Office assessment is to be included with your submission of the research ethics application.