Inclusion and exclusion criteria

In a clinical trial, the investigators must specify inclusion and exclusion criteria for participation in the study. In a clinical trial, the investigators must specify inclusion and exclusion criteria for participation in the study. Inclusion criteria are characteristics that the prospective subjects must have if they are to be included in the study, while exclusion criteria are those characteristics that disqualify prospective subjects from inclusion in the study. In this sense, inclusion and exclusion criteria are usually written in a positive way: if a participant has an inclusion criteria, they are in; if they have an exclusion criteria, they are out. Inclusion and exclusion criteria may include factors such as age, sex, race, ethnicity, type and stage of disease, the subject’s previous treatment history, and the presence or absence (as in the case of the “healthy” or “control” subject) of other medical, psychosocial, or emotional conditions.