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Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study

In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a ‘gold standard’, validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their ...