What should sponsors set to support the control of risks?

• A. Only external supplier qualifications
• B. The trial's publication plan
• C. Pre-specified acceptable ranges, such as quality tolerance limits
• D. The number of sites involved

Answer: (C)

In risk management for a clinical trial, setting pre-specified quality criteria provides a concrete way to control risk. Quality tolerance limits or similar acceptable ranges define the boundaries for critical data and processes. When measurements stay within these limits, the trial is proceeding under known, acceptable conditions; when they exceed the limits, predefined actions—investigation, corrective and preventive actions, and possibly protocol amendments—are triggered. This creates an objective, proactive mechanism to detect issues early and maintain patient safety and data integrity, guiding ongoing monitoring and decision-making.

Relying only on external supplier qualifications addresses part of the risk (the supply chain) but doesn’t offer ongoing, quantitative control over overall trial quality. A publication plan concerns dissemination, not risk control. The number of sites is a design choice that can influence risk exposure but doesn’t establish the monitoring thresholds or action triggers needed to manage risk in real time.