Abstract:

A Risk Based Approach to Monitoring (RBM) guidance released by the EMA and FDA has generated tremendous opportunities and discussions on the prospects of clinical trial monitoring practices. This guidance has raised an array of new tools, technologies and systems to facilitate the approach. However, there is very limited information on the how the clinical trial professionals will have to adapt and adopt their behaviors, skills, competencies and knowledge to leverage the optimal outcome. This paper via literature search and dialogue sessions explores the current working practices and illustrates the evolving role of a clinical trial monitor and key study team members in the RBM landscape. The current working practices suggest that RBM is creating interdependencies between the cross functional team members. This interdependency and appropriate leveraging of the competencies between the study team members is a key component to driving the culture shift towards a more in-stream data visualization, review and quality governance.

KEYWORDS

Risk Based Monitoring, Clinical Trial Monitoring, Clinical Trial Monitor and Quality Governance

References:

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