Eligibility criteria
In Running the trial
Also known as: inclusion and exclusion criteria
Eligibility criteria are the protocol's rules about who may take part. Inclusion criteria describe the characteristics a person must have; exclusion criteria describe what rules them out, usually for safety or to keep the results interpretable. Every criterion must be checked and documented before a participant is enrolled.
Example
Enrolling someone whose laboratory value falls just outside the permitted range, without a documented waiver, is an eligibility deviation — and one of the most frequently reported deviation types.
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