In a quality management system, in which category do risk reduction activities belong?

Risk reduction activities fall underRisk Controlwithin a Quality Management System (QMS). Risk control involves implementing measures to reduce identified risks to an acceptable level, including corrective actions, preventive measures, and continuous monitoring. It aims to mitigate potential negative impacts on trial integrity and participant safety.

GCP guidelines highlight that risk control encompasses actions taken to minimize the likelihood and impact of identified risks.

"Risk control is the process of implementing measures to mitigate risks identified during the risk assessment phase."

Objectives:

Implement effective risk management strategies.

Ensure proactive risk mitigation in clinical trials.