What term refers to the act of overseeing the progress of a clinical trial and ensuring it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and regulatory requirements?

• A. Monitoring
• B. Investigator
• C. IRB
• D. Multicenter Trial

Answer: (A)

Monitoring is the ongoing oversight of a clinical trial to ensure it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and regulatory requirements. This involves site visits, source data verification, checking data quality and integrity, and ensuring safety reporting is timely and deviations are addressed. The investigator is the person conducting the trial at a site and responsible for participant care and protocol adherence; the IRB (or ethics committee) provides ethical review and ongoing protection of participants’ rights and welfare; a multicenter trial describes a study conducted at multiple sites.