The study protocol outlines who can participate in a clinical research study referred to as the Inclusion/Exclusion Criteria. The criteria that allows a person to participate in a clinical research study are called inclusion criteria; and the criteria that disqualifies a potential research subject are called exclusion criteria. These criteria are based on factors such as age, gender, the type and stage of a disease, previous/current treatment history, and other medical conditions. A research subject is a person who meets the inclusion/exclusion criteria and agrees to take part in a clinical research study. A research subject may be either a healthy individual or an individual with a specific disease or condition.