Before you decide to take part in a clinical trial, you should know more about it.

Protocol

Each study has a plan called a protocol. It explains all the facts about the clinical trial, such as:

• The reason for doing the study
• Who can join the clinical trial
• How many people can take part in the trial
• Any drugs those in the trial will be given, the amount they are given, how often they will receive them and how the medication will be given
• What medical tests are given and how often
• What information will be gathered from the study

Informed Consent

Each study also has a process called informed consent. This is how you learn all the facts about the trial before you decide to take part. You must read these facts in a language you can understand and ask your doctor questions about anything you don’t understand. You will get a form that explains:

• Why the study is being done
• All the facts about the treatment and tests
• Possible risks and benefits
• Alternative treatment choices
• Your right to leave the study at any time
• Any costs that might not be paid for
• How your medical records will be kept private

If you agree to take part in a study, you will sign a consent form. Signing the form means you understand all the facts about the trial. Even after you sign the consent form, you can still choose not to be in the study at any time.