Before you agree to participate, the trial team will review all aspects of the clinical trial with you. If you decide to take part, you will be given a document called an Informed Consent FormInformed Consent form (IC)A document that provides information about the purpose of the study, possible risks and benefits, and the participant’s rights and responsibilities. Signing the consent form means that the person agrees to participate in the research; A document used to explain the details of a study (clinical trial) that provides, in writing, the clinical trial’s purpose, assessments, procedures, potential benefits and risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.

The trial team respects and protects your privacy and will not share your information, except as required by law, and will store your personal information with codes that do not identify you. The Informed Consent FormInformed Consent form (IC)A document that provides information about the purpose of the study, possible risks and benefits, and the participant’s rights and responsibilities. Signing the consent form means that the person agrees to participate in the research; A document used to explain the details of a study (clinical trial) (completed by you prior to participation) will provide more information about how your privacy will be maintained.

Your participation in the clinical trial is entirely voluntary and you may withdraw for any reason, at any time. If you do decide to withdraw early, you will be asked to notify the trial team before doing so. You will be asked to return to the trial site at least once to complete a final visit and return any unused trial drug.

No, you will receive the trial drug at no cost. You will also get all trial-related medical tests at no cost.

No, your doctor does not have to give permission for you to participate. However, either you or the trial doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up to date about your progress.

Clinical trials try to answer questions about how medicines work in the people who take them. Researchers run trials to test whether a trial drug is safe and effective. These trials may help doctors find new ways to help prevent, detect, or treat health problems.

Participant safety is the priority. There are rules in place to help protect the rights, safety, and well-being of people who volunteer for clinical trials. These rules are put in place to make sure clinical trials follow strict scientific and ethical guidelines.

Before a clinical trial can begin, a review board or ethics committee must review the clinical trial. In the United States, this group is called an IRB or Institutional Review Board. An IRB is made up of doctors, scientists, and other members of the community.

Only people who meet all eligibility criteria for a clinical trial may take part. The trial team at the site you select will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate. You may also be asked to provide information from your medical records to help the trial team determine whether you may be eligible.

An investigational medicine is a drug that hasn’t yet been approved for use in the general public. In order for it to be approved, the investigational medicine must be tested in clinical trials to see if it is safe and effective for treating the target disease in certain groups of people.

If you have questions about this trial or about taking part, contact the trial site closest or most convenient for you. Use the map above to find contact information.