Which statement best describes the CRO's QA/QC duties?

• A. The CRO Should Implement QA and QC
• B. The Sponsor Should Implement QA/QC Alone
• C. QA/QC Are Not Applicable to CROs
• D. The CRO Is Responsible Only for QC

Answer: (A)

Quality management in CROs means establishing and following systems to prevent problems and to verify that trial activities and data meet ICH-GCP requirements. The CRO should implement both QA and QC within its operations: QA covers the development of processes, training, SOPs, audits, and overall quality systems that prevent noncompliance; QC covers ongoing checks of outputs, such as source data verification, data checks, and data reconciliation. This integrated approach ensures trial quality and regulatory compliance in the work the CRO performs, while the sponsor retains overall responsibility for quality oversight and may delegate these activities to the CRO with appropriate monitoring. Therefore, having the CRO implement both QA and QC best reflects how quality is managed in CRO-conducted trials.