Abstract
Clinical trial quality assurance (QA) covers a whole range of issues in bone mineral density (BMD) assessment. In addition to the regular review of quality control procedures, it also encompasses adequate subject preparation, technologist preparation, observance of rigorous scanning and analysis protocols, and the use of regular, organized data shipments to dual-energy X-ray absorptiometry (DXA) QA centres. All members of the research team should regard these aspects as necessary and important considerations both at the time of clinical trial set-up and throughout the duration of the trial. It is only by implementing and maintaining clear, organized protocols and procedures that accurate and reproducible BMD data will be obtained. Although it is primarily the densitometer technologist who will be responsible for ensuring subject data is adequately acquired, principal investigators and study monitors have a role in ensuring that the technologist is adequately prepared and included as a member of the clinical trial team. The preparation will include both relevant training and trial documentation.
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Earnshaw, S.A. (2007). Clinical Trial Quality Assurance. In: Pearson, D., Miller, C.G. (eds) Clinical Trials in Osteoporosis. Clinical Trials. Springer, London. https://doi.org/10.1007/978-1-84628-587-5_7
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DOI: https://doi.org/10.1007/978-1-84628-587-5_7
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