Abstract
Standard Operating Procedures (SOP's), based on the FDA Good Clinical Practice (GCP) procedures, dealing with all aspects of the organisation of clinical trials, have been established in the Medical Department. The operation of GCP is described.The purpose of the clinical quality assurance function is to verify that SOP's have been followed correctly at all stages of the study. The aim of quality assurance is independently to provide information which will allow an informed judgment relevant to the quality of individual studies. The audit system is discussed.A method for the quantification of the performance of clinical studies, according to GCP, is described.The implementation of clinical quality assurance will improve the quality of management decisions and shorten the drug development process.
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