Inclusion and exclusion criteria
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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.
- 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
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