A Pilot Study to Understand the Acceptance of Clinical Research Industry in Application of Risk-Based Quality Management System to Clinical Trials

Aim: To understand the acceptance of the clinical research industry in the application of risk-based quality management systems to clinical trials.

Methodology: A survey-based study was conducted by taking feedback from 30 clinical research professionals with the help of a validated questionnaire comprising 10 questions. As it was a pilot study the analysis was a considerably basic one by using a percentage method.

Results: 80% (24 participants) feel that failure to identify priorities, poor risk identification, and risk mitigation is the major quality issue, 86.67% (26 participants) mentions that regulatory authorities focus on training and quality assurance and auditing for developing quality systems, 90% (27 participants) opine that re-defining key risk and performance indicators is the most important parameter for RBQM implementation. There is 100% acceptance of the basic idea of risk-based quality management is the identification of the risks on a continuous basis for risk-bearing activities, that Risk-based quality management involves Risk Assessment, Risk Control, Risk review, Risk management, Risk Communication, and agree that while implementing the quality management, the prime objective is to provide assurance that the rights, safety, and well-being of trial subjects are protected.

Conclusion: Acceptance of RBQM by the industry is in line with the guidelines and systems. Collaboration with CROs (i.e. outsourcing model) will always continue to be the best model in bringing better quality in a timely manner.

Keywords: Risk-Based Monitoring, Quality Management, RBQM, Clinical Trials, RBM, Key aspects of RBM, Monitoring.

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