What are Inclusion Criteria?

Inclusion criteria are specific characteristics or conditions that a participant must meet to be considered for enrollment in a clinical trial. These requirements are defined in the clinical trial protocol and typically include factors such as age range, confirmed diagnosis, disease severity, and relevant clinical or laboratory parameters.

Inclusion criteria are used during the screening phase to identify participants who meet the minimum requirements outlined in the study protocol. They help define the target study population by ensuring that participants share key clinical or demographic characteristics relevant to the research objective.

Study teams assess inclusion criteria as part of the screening process before confirming eligibility for further evaluation. These criteria work alongside exclusion criteria to narrow down the participant pool based on protocol-defined requirements.

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.

During study setup, study teams can configure protocol-specific inclusion criteria within Clinion EDC using structured screening forms and predefined fields. This helps ensure that required participant characteristics are consistently captured across study sites during screening.

The system can also help ensure completeness of screening data by highlighting missing or incomplete entries related to inclusion requirements. This supports structured data collection and maintains consistency across participant screening workflows.

A clinical study may specify that participants must be adults between 18 and 65 years of age with a confirmed diagnosis of a target condition. During screening, a participant may meet the age requirement but not yet have confirmation of the diagnosis.

In such cases, the participant would not meet the inclusion criteria and would not proceed further in the screening process for the study.

Eligibility Criteria

Exclusion Criteria

Participant Screening

Clinical Trial Protocol

Subject Enrollment

Study Population

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