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

ABSTRACT:

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 (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 organisations. A first step needed to inform the implementation of RBM is to explore academic trialists' readiness and ability to perform RBM. The aim of this paper is to identify the attitudes and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland.

Methods

This is a mixed-methods, explanatory sequential design, with quantitative surv

SUBMITTER: Hurley C 

PROVIDER: S-EPMC5594426 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature