GLOSSARY

Any adverse event or change in health status or side effect that may occur while a person is participating in a clinical trial, or within a predefined period of time after the study has ended.

A disease, disorder, condition or injury that is being studied and in which the person wishes to participate. It may also include other issues related to health, quality of life and health risks, etc.

Clinical trials are research that involve an intervention that could be a drug, a procedures or a device, or a change to someone’s lifestyle. Clinical trials are used to determine safety and effectiveness of treatments, devices and procedures.

Clinical research refers to a research that involves people who voluntarily participate, or research that is done on samples provided by volunteers such as blood or tissues.

A list of requirements for people wishing to participate in a clinical study or characteristics they must have. There are several types of criteria when the study admits healthy volunteers, such as age, gender, etc.

The different types of eligibility criteria that a person must not have in order to participate in the study. In other words, the reasons why a person is not allowed to participate in a clinical study.

Different types of eligibility criteria that a person must meet to participate in a clinical study.

Healthy individuals are given the treatment to ensure it is safe, to determine dosage, and to determine side effects.

Individuals with the medical condition being studied are given the treatment and observed to further assess safety, dosage and to see if it works as intended.

Larger groups of individuals with the medical condition being studied are given the treatment and tested to see how well a treatment works over a longer period of time, and also to further assess safety and side effects.

Once a treatment has shown to be effective and has been approved by the appropriate regulatory body (Health Canada, DFA, etc), its long-term effects and safety are studied in a real-world context.