Risk Based Monitoring (RBM): A global study focusing on perception and merits among clinical investigational sites

摘要

BackgroundSeveral approaches to clinical trial monitoring, including the Risk Based Monitoring (RBM) are aimed at the protection of the human subjects (safety), improved data quality, and ultimately, reducing the cost of drug development and operations. There exists minimal evidence globally about the perceptions and the level of confidence among the clinical staff on the merits of RBM. The present study assessed the perception among clinical research staff globally (developed and emerging countries) on the applicability and adaptability of RBM.