Certified Clinical Research Coordinator (CCRC) Practice Exam

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A candidate meets every inclusion criterion but has a laboratory value that violates a protocol-defined exclusion criterion. What is the best enrollment decision?

Enroll because inclusion criteria take priority Enroll if the coordinator documents the reason Delay enrollment until after the first dose Do not enroll unless the protocol permits eligibility and any required approval process is completed

Correct Answer:

Do not enroll unless the protocol permits eligibility and any required approval process is completed

Explanation:

Eligibility requires satisfaction of the protocol's applicable inclusion and exclusion criteria. A coordinator cannot override an exclusion criterion merely by documenting a rationale.

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