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- What are Eligibility Criteria?
- Where are Eligibility Criteria Used in Clinical Trials?
- How Clinion Supports Eligibility Criteria
- What it looks like in practice
- Related Terms
- Related Articles
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What are Eligibility Criteria?
Eligibility criteria are predefined requirements used to determine whether a participant can enroll in a clinical trial. These criteria typically include inclusion and exclusion conditions related to factors such as age, medical history, disease condition, prior treatments, laboratory values, and overall health status.
Where are Eligibility Criteria Used in Clinical Trials?
Eligibility criteria are used during participant screening and enrollment to identify individuals who are appropriate for a clinical study. They help ensure participant safety, maintain study consistency, and support accurate evaluation of treatment outcomes across the trial population.
Study teams review eligibility requirements before participant enrollment to confirm that all protocol-defined conditions are met. Failure to follow eligibility criteria correctly may lead to protocol deviations, protocol violations, or inaccurate study results.
How Clinion Supports Eligibility Criteria
During study design, study teams can configure protocol-specific eligibility criteria, screening forms, and enrollment workflows within Clinion EDC based on the study requirements. These configurations help support consistent participant screening and enrollment processes across research sites.
The platform can also help identify missing information, incomplete assessments, or potential eligibility mismatches before participant enrollment. Centralized visibility across screening and study records supports traceability and helps maintain protocol compliance throughout enrollment activities.
What it looks like in practice
A clinical study may require participants to be between 18 and 65 years of age, have a confirmed diagnosis of a specific condition, and meet defined laboratory value thresholds before enrollment. During screening, a participant might meet the age and diagnosis requirements but fail to meet the required laboratory criteria.
Based on the study protocol, the participant would then be considered ineligible for enrollment in the clinical trial.
Category
Study Setup & Design