Inclusion and exclusion criteria

For Wikipedia's inclusion criteria, see: What Wikipedia is not.

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. 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.

Example of Inclusion and exclusion criteria

Coronary Heart Disease

Include criteria:

Minimum outcomes: coronary deaths & non-fatal myocardial infarction

Appropriate measures of Framingham variables (Age, sex, LDL, HDL, total cholesterol, diabetes, smoking status, hypertension)

Cohort, nested case-control, cardiovascular trial follow-up study (or systematic review or meta-analysis of these study types) that measures a novel risk factor and estimates its predictive value after adjusting for Framingham variables

Exclude criteria:

No data

Population or sub-population with known coronary disease or coronary disease equivalent (e.g., diabetes

Does not include minimum outcomes

Does not measure Framingham variables appropriately

Wrong study design/article format

See also

• Drug development
• U.S. Food and Drug Administration (FDA)
• European Medicines Agency

External links

• ICH Website: Guidelines for Clinical Trial Management
• FDA Website
• Clinical Research Training Clinical Trials Management
• Careers in Clinical Research
• Clinical Research Services
• Clinical Trial Management Companies Listings
• International Clinical Research Services and Corporate Trainings
• Clinical Research Abbreviations and Acronyms
• Clinical Research Glossary /Definitions
• List of Food and Drugs Regulatory Agencies
• Clinical Research: Frequently asked questions