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To determine participant suitability for a clinical trial, investigators must review both the full protocol and the Investigator's Brochure. The full protocol outlines the study's objectives, design, methodology, statistical considerations, and participant eligibility criteria. This document provides essential information that informs investigators of the specific requirements and constraints for participant selection, which helps ensure that the study adheres to scientific and ethical standards.

The Investigator's Brochure complements this by providing detailed information about the investigational product(s), including pharmacological data, safety information, and background relevant to the study. Together, these two documents equip investigators with the comprehensive information necessary to evaluate whether a potential participant meets the defined criteria and qualifications for the study, thus safeguarding the integrity of the data collected and the wellbeing of participants.

In contrast, the budget proposal and recruitment strategies, while important for the conduct of the study, do not provide direct information regarding the suitability of individual participants for the trial. Therefore, they are not sufficient on their own for this specific assessment.