What does the term 'risk management' in clinical trials refer to?

The term 'risk management' in clinical trials refers specifically to identifying, evaluating, and controlling risks associated with the conduct of the trials. This process is essential in ensuring the safety of participants and the integrity of the study. By systematically identifying potential risks, researchers can prioritize them based on their likelihood and impact, and then implement strategies to either mitigate or monitor these risks throughout the trial. This proactive approach helps in safeguarding participant welfare, complying with regulatory requirements, and maintaining the quality of the trial results.

In contrast, attempting to eliminate all risks entirely is not feasible or realistic in clinical research, as some degree of risk is inherent in any clinical trial. Evaluation of protocols by external committees, while important for oversight and ethical review, is not the comprehensive process of risk management. Maintaining confidentiality of participant data is also a critical aspect of clinical trials but does not encompass the broader risk management scope, which includes both participant safety and study integrity.