Quality assurance activities require written SOPs. Who is responsible for implementing and maintaining QA/QC systems with written SOPs?

• A. The sponsor is responsible for implementing and maintaining QA/QC systems with written SOPs
• B. The investigator is solely responsible for SOPs
• C. SOPs are optional
• D. QA/QC SOPs apply only to data collection

Answer: (A)

The main idea is that the sponsor owns the quality framework for a clinical trial. QA/QC systems with written SOPs are developed and maintained by the sponsor to standardize how study activities are conducted, handled, and documented. This includes creating the SOPs, ensuring they are up to date, and implementing the QA program that oversees audits, monitoring, data integrity, and participant safety across all sites. Investigators and site staff must follow these SOPs and participate in QA activities, but they do not establish or maintain the sponsor’s QA/QC system. SOPs are not optional, and the responsibility for the quality program extends beyond just data collection.