Each trial has a principal investigator in charge of the study, who prepares a plan called a protocol. The protocol outlines what the trial will do, who can participate, what information will be gathered about patients, the risks and benefits of the trial, and more.
Participants will receive an informed consent form, which includes written details about the study. Those who agree to join the clinical trial sign the form. Even after signing the form, participants retain the right to leave the trial at any time.
It is a patient’s right to decline participation in clinical trials and research projects, without any influence on the treatment provided.
Confidentiality is another important part of patient safety. In Canada, your privacy is considered a constitutional right. Learn more about how an organization collects, uses and discloses personal information in the Personal Information Protection and Electronic Document Act (PIPEDA).
You may be thinking about taking part in a clinical trial or participation may have been suggested by your doctor. Speaking to your doctor or healthcare provider can help you answer questions about the available trials and whether or not you’re eligible.
Each clinical trial comes with its own protocol, eligibility criteria, risks and benefits. It is important to understand each of these before enrolling in a trial. Discuss the details of a trial with your healthcare team.
Accrue / uh-kroo / v. – individual has signed a consent form and then is randomized/registered.
Standard of Care / n. – the treatment currently being used to treat a disease or condition that is accepted and considered to be effective.