The European Medicines Agency (EMA) publishes “Reflection Papers” to communicate expectations to industry.
This draft guidance was released for public comment in August, 2011. The comment period extends through February 15, 2012.
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 2, Problem Statement – lists ‘piecemeal implementation of technology, with fragmented, unconnected and poorly standardised solutions’ as a problem with current practices
Section 4, lists ‘computerised systems’ and ‘setup of trial databases’ as a clinical trial elements that should be evaluated to identify risks
Section 4.A.5.e, 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”
ANNEX 1 on Risk Identification and Mitigation lists ‘requirements for computerised system validation’ as a risk for consideration and mentions the proper use of databases as a mitigation approach for multiple risks.