To ensure your safety and get meaningful results, the clinical trial must follow strict rules described in the research plan. This is called the clinical trials protocol.
The protocol is the research plan of action, like a recipe or instruction manual. It describes the “who, what, when, where, why and how” of taking part in a clinical trial. All of the information contained in the protocol is summarized in the informed consent form, so patients are not given a copy of the protocol.
It contains all the information required to do the trial, such as:
Why the research is being done
The purpose and goal of the clinical trial
The scientific background information, including information on pre-clinical and early phase clinical trials
The Principal Investigator
The eligibility criteria, which determines if you are able to take part.
Each clinical trial protocol has a strict list of eligibility criteria to ensure patient safety
The total number of patients needed to take part
Treatment information, such as the name of the trial drug or treatment, the dose, how it is given and how often, and storage information
Possible side effects, risks, and benefits of the new treatment
What to do if there are side effects
The frequency of your visits and all of the procedures that will be done at each visit
How long the clinical trial is expected to last
What information will be collected about you and how it will be used
How to determine if the treatment is working or not working
Your rights, including the right to stop participating in the trial at any time for any reason
How long records need to be stored
Find a Trial
As you consider your treatment options, there may be a clinical trial that is right for you, here at the Juravinski Cancer Centre.
Find a Trial