Jill Cernohous, Senior Clinical Principal Advisor
ICH E6(R2) requires sponsors to implement a system to manage quality throughout all stages of a clinical study. This process should be based on study activities that could have the greatest impact on human subject protection and the reliability of study results (or highest risks), and goes beyond risk-based monitoring.
Making it work
To achieve this standard, a quality management system should be implemented using a risk based approach across all aspects of a clinical study from start (development of the protocol) until the end (final report). The risk based approach should include risk identification, risk evaluation, risk control/mitigation, risk communication (including documentation of all processes, activities and outcomes), risk review (ongoing throughout the entire study), and risk reporting. In addition, FDA guidance discusses risk management in the context of clinical monitoring but goes on to note the importance of conducting a risk assessment to manage risks across the entire clinical study or development program.
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