European Forum for Good Clinical Practice Guideline
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GUIDELINES
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European Forum for Good Clinical Practice Guideline The Role of the Quality Assurance Unit Paul Strickland, on Behalf of the European Forum for Good Clinical Practice Audit Working Party European Forum for Good Clinical Practice Audit Working Party, Brussels, Belgium
For a new Quality Assurance Unit (QAU), with responsibility for auditing clinical trials, the choice of which activities to prioritize can be bewildering. There will be many pressures from colleagues in other areas of the organization who will be asking for help, and the resources of the QAU will have to be allocated carefully in order to maximize their effectiveness. This may mean that not all of the roles described in this article can be conducted by all units. For small units in particular, the focus should be heavily on auditing, rather than other activities.
1. What is Quality Assurance (QA)? The global guideline for good clinical practice (GCP) is accepted to be the International Conference on Harmonisation (ICH) E6 document,[1] which defines quality assurance (QA) as ‘‘all those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with [GCP] and the applicable requirements.’’ For those in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) definition of QA is as follows: ‘‘It is the sum total of the organized arrangements made with the
object of ensuring that medicinal products or services are of the quality required for their intended purpose.’’[2] While many groups that audit provide advice and assist with inspection facilitation have the name ‘Clinical Quality Assurance’, this term is slightly misleading because all members of the organization are responsible for quality. The quality level of the work is set when the work is done and cannot be increased retrospectively during an audit. Figure 1 shows that QA encompasses all of the quality control (QC) activities as well as auditing. It is not audit by itself. Furthermore, the number of staff performing QC is huge in comparison with those performing audit. From this, it is clear that the responsibility for quality can only lie with the staff conducting the work initially. In this explanation of QA, the term is synonymous with the ‘Quality Management System’ – the totality of documents, processes, reporting relationships, etc., that describe what is to be done; how it is to be recorded, checked and audited; who is to do the role and what training they require. Having covered the formal definition of QA, we will now move on to the accepted use of it. In this article, the QAU is understood to be conducting audits, and providing advice and consultation, but to have no QC responsibilities.
2. Background
Quality control Monitoring, edit checks, proof reading, validation
Quality assurance
Audit
Fig. 1. Quality assurance incorporates both quality control and audit.
This guideline on the role of
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