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Clinical Trial
. 1979 May;25(5 Pt 2):703-11.

Quality assurance of clinical data: diagnostic standardization

  • PMID: 373959
Clinical Trial

Quality assurance of clinical data: diagnostic standardization

H A Kahn. Clin Pharmacol Ther. 1979 May.

Abstract

Diagnostic standardization requires substantial effort, including detailed specification of procedures in a written protocol and training of examiners in such procedures. Success is neither automatic nor assured. It is essential to monitor performance through replicate examinations and/or computation of examiner variance. When examiner variance exceeds permissible limits, consideration should be given to discarding the data.

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