Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

Reconciliation of drug usage during a study is critical for ensuring data integrity and participant safety. The correct approach involves reviewing the paper trail, which includes shipping records. This method allows researchers to track the flow of the investigational drug from the manufacturer to the study site and ultimately to the participants. By examining documents associated with drug handling—such as shipping logs, inventory records, and dispensation logs—researchers can verify that the amounts distributed, administered, and returned align with the study protocol and that no discrepancies exist. This comprehensive review helps ensure that all drug usage is accounted for, thereby maintaining accuracy in study results and compliance with regulatory requirements.

Other options, while they may have their own uses in certain contexts, do not provide the thorough auditing capability necessary for drug reconciliation. Random sampling might miss out on capturing specific instances of drug usage, electronic tracking systems might be too automated without proper oversight, and direct observation could be useful but may not provide comprehensive data regarding all doses administered throughout the study duration.