How does a clinical trial work?

A clinical trial is based on a plan called a protocol. The protocol helps ensure your safety as the study addresses research questions. It describes details about the clinical trial, such as

  • who can and cannot participate in the clinical trial
  • how long participants will be in the clinical trial
  • study medicines, including the dose and how the medicine is to be taken
  • test and procedures that are required for the clinical trial

If you decide to take part in a clinical trial, a member of the study staff will discuss the protocol with you and get your informed consent.

What is informed consent?

This is an important process that educates you about the purpose and possible risks and benefits of a clinical trial. It is required that you receive this information from the research team of doctors and nurses before you decide whether to participate. At this time, you are also informed of your right to

  • make a decision about participating
  • leave the trial at any time, for any reason

Once the research team has discussed the clinical trial with you—in a way that you fully understand and answers any questions you may have—you will receive an informed consent form. An informed consent form is a written document that

  • outlines all of the information about the clinical trial
  • provides detail about how your health information is protected

If you understand the information provided and completely agree with what you have read, you will be asked to sign the informed consent form.

Remember

Even if you sign the informed consent form, you always have the right to leave the clinical trial at any time, for any reason.