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Data quality of the clinical trial process - Costly regulatory compliance at the expense of scientific proficiency
Linköping University, The Institute of Technology. Linköping University, Department of Management and Engineering, Quality Technology and Management .
2004 (English)In: Quality Assurance Journal, ISSN 1087-8378, Vol. 8, no 3, 177-182 p.Article, review/survey (Refereed) Published
Abstract [en]

The reasons for the belief in the need for perfection of clinical data are carefully nursed myths. The logical shortcomings in Good Clinical Practice are nothing but embarrassing to its scientifically trained promoters. Modern quality management methods, which increasingly degrade the importance of inspections, are described and their application in clinical research recommended. The documentation of procedures to attain acceptable quality levels of trial data is suggested to be standardized into a Quality Declaration. Copyright © 2004 John Wiley & Sons, Ltd.

Place, publisher, year, edition, pages
2004. Vol. 8, no 3, 177-182 p.
Keyword [en]
Good clinical practice, Good manufacturing practice, Process analytical technology, Quality assurance, Quality declaration, Quality management
National Category
Engineering and Technology
URN: urn:nbn:se:liu:diva-45649DOI: 10.1002/qaj.288OAI: diva2:266545
Available from: 2009-10-11 Created: 2009-10-11 Last updated: 2011-01-12

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Lörstad, Mats
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