What term describes the planned and systematic actions to ensure trial activities comply with GCP and regulatory requirements?

• A. Quality Assurance
• B. Protocol Amendment
• C. Source Data
• D. Regulatory Authorities

Answer: (A)

Quality Assurance is the planned and systematic set of actions designed to ensure trial activities comply with GCP and regulatory requirements. It provides the framework for quality across the study, including establishing SOPs, training, qualification of staff and facilities, vendor oversight, audits, monitoring, and continuous process improvements. By implementing QA, the sponsor and investigators gain confidence that the trial is conducted, data are generated and reported according to the protocol and regulations, and any deviations are detected and corrected promptly. This goes beyond a single protocol change, the data collected, or the regulatory bodies themselves, which are enforcement entities rather than the proactive systems to ensure compliance.