Process Thinking in Clinical Trials
ICH E6 (R2) has emphasized the importance of risk management in relation to ensuring subject safety and rights as well as data integrity in clinical trials.
Understanding, oversight and improving clinical trial processes, is a fundamental way of managing these risks. this course demonstrates ways to map processes, how to measure them and to understand how they might fail.
It provides a tool kit for root cause analysis and provides approaches to improve processes so as to minimize risk. Throughout, examples are used from clinical trials and participants are encouraged to practise the skills they learn.
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