EMA Reflection Paper on Risk Based Quality Management in Clinical Trials, 11/13

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The European Medicines Agency (EMA) publishes”Reflection Papers” to communicate expectations to industry.

This EMA’s Reflection Paper on Risk Based Quality Management in Clinical Trials was published on November 18, 2013.

The purpose of this reflection paper is to facilitate the development of a more systematic, prioritized, risk-based approach to quality management of clinical trials, to support the principles of Good Clinical Practice and to complement existing quality practices, requirements and standards.

See the following sections of Reflection Paper on Risk Based Quality Management in Clinical Trials for these computer system topics:

• Section 1, ‘Introduction’ – lists ‘validation of computerised systems’ as a key element of the quality system
• Section 1, Problem Statement – lists ‘piecemeal implementation of technology, with fragmented, unconnected and poorly standardised solutions’ and ‘stifling of innovation’ as a problem with current practices
• Section 3, ‘Risk Based Quality Managements’ – allows for the use of information technology in the detection, identification, predication, and analysis of metrics for risk management and decision making
• Section 4,’Risk Assessment’ – lists ‘computerised systems’ and ‘setup of trial databases’ as a clinical trial elements that should be evaluated to identify risks
• Section 5.1 ‘Risk Mitigation / Risk Acceptance’ – recommends that study sponsors develop IT-tools and automatic data interfaces to be able to use existing data in different databases for risk assessment and risk mitigation