What is the primary purpose of QA/QC systems in GCP?

• A. To speed up trial initiation
• B. To maximize data volume regardless of accuracy
• C. To ensure trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and regulatory requirements
• D. To minimize regulatory oversight

Answer: (C)

Quality assurance and quality control in GCP exist to safeguard the integrity of the trial process and the data by ensuring everything is conducted, documented, and reported in accordance with the protocol, GCP, and regulatory requirements. QA provides independent oversight of processes, systems, training, and documentation to prevent problems and drive improvements. QC focuses on the outputs—data, source documentation, and study reports—to ensure they are accurate, complete, and verifiable. This framework protects participant rights and safety and supports credible, compliant trial results for regulatory submissions. It isn’t about rushing trial initiation, increasing data volume at the expense of accuracy, or reducing regulatory oversight.