PATIENT SAFETY & CONFIDENTIALITY
How can I ensure patient safety and confidentiality?
You must inform participants of all the potential risks and benefits of participating in the study. Each participant must sign an informed consent form, acknowledging understanding of the details of the clinical trial.
Even with a signed informed consent form, a participant can withdraw from a study at any time. Health Canada and your local Research Ethics Board can answer specific questions you may have about patient safety.
To ensure patient confidentiality, you must collect and manage any personal information in accordance with the Personal Information Protection and Electronic Document Act (PIPEDA).
Investigators must adhere to appropriate policies and exercise sensible medical decisions in order to be indemnified from any legal actions which may arise from a clinical trial. Acting as a clinical trial investigator should not affect your malpractice insurance premiums.