Abstract
The skills required of a Clinical Quality Assurance (CQA) auditor are similar to those required for a Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP) auditor, with perhaps more emphasis on interpersonal skills and a requirement for more international travel. However, the role of the CQA and the Good Clinical Practice (GCP) function is still evolving. In general, the tasks required of the CQA auditor involve the reviewing and compliance verification of quality systems throughout the clinical development process, from the design of the protocol to the final clinical study report. Other desirable qualities of the CQA auditor are described. Published in 2000 by John Wiley & Sons, Ltd.
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