The extent and nature of monitoring should be based on considerations such as objective, purpose, design, complexity, blinding, size, and endpoints. True or False?

• A. True
• B. False
• C. Not specified
• D. Only for Phase II trials

Answer: (A)

Monitoring should be tailored to the trial’s characteristics and risk. In GCP, a risk-based approach means the extent and nature of monitoring are driven by factors such as the trial’s objective and endpoints, design and complexity, size, whether blinding is involved, and the overall purpose. These elements determine what data and processes need closer verification, how often monitoring occurs, and whether centralized data checks or targeted on-site visits are appropriate. For straightforward, smaller studies with clear endpoints, less intensive monitoring may suffice, while larger, more complex, or blinded studies with critical endpoints typically require a more robust, risk-based monitoring plan to protect participants and ensure data integrity. The statement is true and reflects the risk-based monitoring principle outlined in ICH GCP.