Glossary Term
Inclusion/Exclusion Criteria
Definition
Inclusion and exclusion criteria are predefined conditions or characteristics that determine a participant’s eligibility to enroll in a clinical trial. Inclusion criteria specify the attributes participants must have to join the study, while exclusion criteria outline the characteristics or conditions that disqualify individuals from participation.
Relevance to the MedTech Industry
Inclusion and exclusion criteria ensure that clinical trials are conducted with a well-defined and appropriate participant population. These criteria help to minimize variability, enhance the validity of results, and protect participant safety by excluding individuals for whom the intervention may pose undue risks or produce unreliable data. They are essential for establishing scientifically valid evidence to support the safety, effectiveness, or performance of medical devices.
Additional Information & Related Terms
Related Terms
Clinical Trial Protocol: The document that defines the trial’s objectives, methods, and criteria, including inclusion and exclusion conditions.
Risk-Benefit Analysis: Ensures that criteria protect participants while enabling meaningful study results.
Post-Market Surveillance (PMS): Informs ongoing safety and effectiveness monitoring for populations included or excluded in trials.
Patient Selection Bias: Avoided by clearly defining and adhering to inclusion/exclusion criteria.