Recruiter's Glossary

Examples: Phase III • Source Documentation • Study Timeline

Exclusion Criteria

Term from Clinical Trials industry explained for recruiters

Exclusion Criteria are the rules that determine who cannot participate in a clinical trial. Think of it like a checklist of conditions or characteristics that would make it unsafe or inappropriate for someone to join a medical study. For example, this might include people with certain health conditions, those taking specific medications, or individuals in particular age groups. Clinical research professionals use these criteria to ensure participant safety and maintain the quality of their research data. You might also see this referred to as "exclusion requirements," "study exclusion factors," or "exclusion parameters" in job descriptions and resumes.

Examples in Resumes

Developed Exclusion Criteria for Phase III diabetes medication trials

Reviewed and refined Exclusion Criteria across 15 multi-center clinical studies

Trained site staff on proper application of Exclusion Criteria and Study Exclusion Parameters

Typical job title: "Clinical Research Associates"

Also try searching for:

Clinical Research Coordinator Clinical Trial Manager Clinical Operations Manager Clinical Research Manager Clinical Study Manager Protocol Developer Clinical Research Associate

Where to Find Clinical Research Associates

Professional Organizations

Online Communities

Job Boards

Example Interview Questions

Senior Level Questions

Q: How would you handle a situation where a study site consistently misinterprets exclusion criteria?

Expected Answer: A senior professional should discuss implementing additional training, creating clearer guidance documents, establishing regular quality checks, and possibly revising the criteria language for clarity while maintaining protocol integrity.

Q: What factors do you consider when developing exclusion criteria for a global clinical trial?

Expected Answer: Should mention considering regional differences in medical practices, local regulations, population characteristics, available diagnostic tools, and cultural factors while ensuring consistent application across all sites.

Mid Level Questions

Q: How do you ensure consistent application of exclusion criteria across multiple study sites?

Expected Answer: Should discuss developing standardized training materials, regular site communication, monitoring reports, and providing clear documentation and examples for site reference.

Q: What steps do you take when reviewing potential protocol violations related to exclusion criteria?

Expected Answer: Should explain the process of documenting the violation, assessing impact on patient safety and data integrity, implementing corrective actions, and preventing future occurrences.

Junior Level Questions

Q: What is the difference between inclusion and exclusion criteria?

Expected Answer: Should explain that inclusion criteria define who can participate in a study, while exclusion criteria specify who cannot participate, even if they meet inclusion criteria.

Q: Why are exclusion criteria important in clinical trials?

Expected Answer: Should discuss participant safety, data quality, and how proper criteria help ensure study results are reliable and applicable to the intended population.