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
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Jergas M, Genant HK. Lateral dual X-ray absorptiometry of the lumbar spine: Current status. Bone 1997; 20: 4311–14.
Blake GM, Herd RJM, Fogelman I. A longitudinal study of supine lateral DXA of the lumbar spine: A comparison with posterior spine, hip and total-body DXA. Osteoporos Int 1996; 6: 462–70.
Formica CA. Total body bone mineral and body composition by absorptiometry. In: Blake GM, Wahner HW, Fogelman I (eds). The Evaluation of Osteoporosis: Dual Energy X-ray Absorptiometry and Ultrasound in Clinical Practice, 2nd edn. London: Martin Dunitz, pp 31346, 1999.
Wahner HW, Fogelman I. The Evaluation of Osteoporosis: Dual Energy X-ray Absorptiometry in Clinical Practice. London: Martin Dunitz, pp 49–74, 1994.
Lunar DPX-L Operators Manual Documentation Version 8/93. Lunar Corporation, Madison, Wisconsin, USA.
Lunar Expert-XL User’s Guide Documentation Version 2/98 1. Lunar Corporation, Madison, Wisconsin, USA.
Hologic QDR 2000 Operators Manual and User’s Guide. Hologic System Software Version 7.10. Document Number 080–0384 Revision A. Bedford, MA, Hologic Inc.
Masud T, Langley S, Wiltshire P, Doyle DV, Spector TD. Effect of spinal osteophytosis on bone mineral density measurements in vertebral osteoporosis. BMJ 1993; 307: 172–3.
Liu G, Peacock M, Eilam O, Dorulla G, Braunstein E, Johnston CC. Effect of osteoarthritis in the lumbar spine and hip on bone mineral density and diagnosis of osteoporosis in elderly men and women. Osteoporos Int 1997; 7 (6): 564–9.
Steiger P, Cummings SR, Genant HK, Weiss H, and the Study of Osteoporotic Fractures Research Group. Morphometric X-ray absorptiometry of the spine: Correlation in vivo with morphometric radiography. Osteoporos Int 1994; 4: 238–44.
Rea JA, Steiger P, Blake G, Potts E, Smith IG, Fogelman I. Morphometric X-ray absorptiometry: reference data for vertebral dimensions. J Bone Miner Res 1998; 13 (3): 464–74.
Cawte SA. Morphometric X-ray absorptiometry using the Hologic QDR 2000. MPhil thesis, University of Nottingham, 1999.
Blunt BA, Jones D, Svenson RK, Hans DA, Feinblatt JD, Genant HK. Good clinical practice and audits for dual X-ray absorptiometry and X-ray imaging laboratories and quality assurance centres involved in drug trials, private practice, and research. J Clin Densitometry 1998; 1 (4): 323–37.
McDonald V. Surviving an FDA audit. Clin Res Focus 1994; 5 (2): 12.
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2002 Springer-Verlag London
About this chapter
Cite this chapter
Cawte, S. (2002). Clinical Trial Quality Assurance. In: Pearson, D., Miller, C.G. (eds) Clinical Trials in Osteoporosis. Springer, London. https://doi.org/10.1007/978-1-4471-3710-8_7
Download citation
DOI: https://doi.org/10.1007/978-1-4471-3710-8_7
Publisher Name: Springer, London
Print ISBN: 978-1-85233-229-7
Online ISBN: 978-1-4471-3710-8
eBook Packages: Springer Book Archive