|Title||QUALITY RISK MANAGEMENT AS THE BASIS OF RISK BASED MONITORING|
Pranjal R Chaturvedi, Mohammed Saleem Khan & Bharat Kumar Shukla
Quality Risk Management (QRM) systematically evaluates risk and applies set of standards to quality based on scientific evidences, to take care patient safety & well-being and not compromising on quality of a process. As ICH-Q9 cites, the two primary principles of quality risk management are: -The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient. -The level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk. This article will evaluate the importance of Quality Risk Management in Risk Based Monitoring i.e. to study the development of a more systematic risk based approach to the quality management in clinical trials management in compliance with Good Clinical Practices.