In a clinical trial, the investigators must specify inclusion and exclusion criteria for participation in the study.
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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. 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.
Inclusion and exclusion criteria are ment ot ensure patients safety during the study, provide data (justification) of subject appropriateness for the study, to minimize withdrawl (also costs) and ensure that primary end-points of study are reached.
Exclusion criteria
Poorly Justified Reasons for Exclusion:
Strongly Justified Reasons for Exclusion:
Potentially Justified Reasons for Exclusion
Example of inclusion and exclusion criteria
Coronary Heart Disease
Include criteria:
Exclude criteria: