Eligibility Criteria Section
CONSORT 2025 treats participant eligibility criteria as important reporting information because inclusion and exclusion rules affect how readers interpret the study population and applicability. CONSORT is a randomized-trial reporting guideline; other study designs and disciplines can use different reporting frameworks or headings.
An Eligibility Criteria section states the inclusion and exclusion rules that determined who or what could enter the study.
Key details
Important caveats
Scope Boundary
CONSORT is a randomized-trial reporting guideline; other study designs and disciplines can use different reporting frameworks or headings.
Further guidance
Content
Do not substitute final participant demographics for entry rules; describe recruitment or sampling mechanics separately when they need their own explanation.
Purpose
Give operational inclusion and exclusion criteria clearly enough for readers to understand the intended eligible population and when the criteria were applied.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- CONSORT 2025 statement: updated guideline for reporting randomised trials (opens in a new tab)The BMJ / CONSORT · CONSORT 2025 reporting guidance for participant eligibility criteria and recruitment information in randomized trials