Good Clinical Research Practice and Quality Assurance

Abstract

The terms ‘Good Clinical Practice’ and ‘Good Clinical Research Practice’ have entered the everyday vocabulary of the clinical researcher and imply a mystique around the subject that really does not exist. The purpose of good clinical practice is several-fold. It is to ensure, first, that persons who agree to participate in any clinical research protocol are protected from unnecessary risk as the study is conducted in accordance with a set of well-thought-out procedures; second, that the data collected from the study are of sufficiently high quality to fulfil the original purpose; third, that there is a means of auditing; finally, that the resources that have been expended on the study, human and financial, have been used to their best effect.