A clinical trial is a type of research that studies a treatment given to people. Clinical trials study how safe and helpful treatments are. Clinical trials can study many things, such as:

• New medications not yet approved by the U.S. Food and Drug Administration (FDA),
• New uses of medications already approved by the FDA,
• New ways to give medications, such as a pill or injection

All clinical trials have certain criteria for who can participate. These criteria are called inclusion and exclusion criteria which can include age, type of disease, previous treatment history, medication history, and medical history. A patient must meet all inclusion and none of the exclusion criteria to qualify to participate in a trial.

Informed consent is the process of learning about all aspects of the clinical trial before making the decision to participate. Each clinical trial has an informed consent form (ICF) that is provided to the participants. The ICF describes the purpose of the study, duration of the study, side effects of the investigational product or device, risks and benefits of participating in the study, study procedures, and participant compensation. After reading the ICF, time is given to answer any questions. The participant will then sign the form if they decide to participate in the study.

If you decide to participate in a clinical trial, you will most likely be assigned a study number. All data and samples collected will be identified by a study number and your identity will remain unknown. Personal information about you that is collected will only be seen by the study team unless you are informed otherwise.

Yes.

For most studies, research participants will be compensated for time and travel for each completed visit. The amount varies with each study. Compensation will be provided to you on a USF Clincard. The Clincard works just like a debit card and can be used anywhere a debit card is accepted.

A placebo is a pill, liquid, powder, or cream that does not contain any active medication. The placebo will look and taste the same as the study drug but will not contain any medication. For certain studies, some participants may receive a placebo.

Yes.

At any time during the trial you may withdrawal your consent. When withdrawing from the trial, the participant should let the research team know about it. There will be no penalty to you.