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Clinical Trial Quality Assurance

  • Susan Cawte

Abstract

Clinical trial quality assurance covers a whole range of issues in bone mineral density 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 DXA quality assurance centers. 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 bone mineral density 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 is included as a member of the clinical trial team. The preparation will include both relevant training and trial documentation

Keywords

Lumbar Spine Proximal Femur Subject Position Floppy Disk Data Shipment 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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© Springer-Verlag London 2002

Authors and Affiliations

  • Susan Cawte

There are no affiliations available

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