Each trial has a principal investigator in charge of the study, who prepares a plan called a protocol to outline 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. If you agree to join the clinical trial, you sign the form. Even after you sign the form, you retain the right to leave the clinical trial at any time.
It is a patient’s right to decline participation in clinical trials and research projects, without any influence on treatment provided.
Confidentiality is another important part of patient safety. In Canada, your privacy is considered a constitutional right. Learn more about how any 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 it 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.
Quality Control (QC) / n. – the operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.