Who bears responsibility for implementing and maintaining quality assurance and quality control systems in a trial?

• A. The investigator
• B. The regulatory authority
• C. The sponsor
• D. The independent monitor

Answer: (C)

The sponsor bears responsibility for implementing and maintaining quality assurance and quality control systems because they oversee the trial's integrity from start to finish. The sponsor designs and establishes the QA program, including SOPs, training, vendor qualification, and audits, with a quality assurance unit often auditing sites and processes to verify compliance with GCP and the protocol. QA sets the framework and rules, while QC involves the actual checks that ensure data and activities meet those standards, such as data verification, edit checks, and data cleaning, all guided by the sponsor’s QA program. The investigator is responsible for conducting the trial at the site in compliance with the protocol and GCP and for maintaining accurate records, but they do not establish or maintain the trial-wide QA/QC systems. Regulatory authorities regulate and inspect but do not implement QA/QC systems, and independent monitors provide oversight to ensure protocol adherence, not to run the sponsor’s QA program.