Clinical trial studies entail several complex elements that must be firmly monitored to guarantee the participant safety, uphold study protocol, and comply with regulatory requirements.

Efficient monitoring is essential in the clinical trial for safeguarding the well-being of the trial participants and ensuring the integrity of high-quality studies. Sponsors must bear the responsibility of overseeing trials to uphold the rights, welfare and safety of human subjects as well as the reliability of the trial relevant data.

Regulatory agencies like FDA and EMA mandate sponsors to monitor clinical investigations, encouraging them to develop risk-based monitoring plans that manage human subject risks and data quality. This approach focuses on preventing or managing significant risks to data integrity, human subject protection, and trial credibility, leveraging modern clinical trial methodologies.

FDA and EMA defined risk-based monitoring (RBM) as a crucial part of clinical trial management strategies, that involves a blend of centralized and on-site procedures to ensure human subject welfare and trial ethics. RBM aims to identify, assess, manage, communicate, and review risks throughout the trial’s duration, ensuring safety, and integrity, protection of subjects’ rights, data quality, and trial credibility.