Browsing University of Galway Support Services by Subject "ich-gcp"
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Perceived barriers and facilitators to risk based monitoring in academic-led clinical trials: a mixed methods study
(Springer Nature, 2017-09-11)Background: 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 ...