ABSTRACT

The main purpose of an audit is to ensure that the trial has been conducted as defined in the protocol. An audit also assists in improving standards. An audit may identify deficiencies; if they are rectified when detected, quality will improve, irrespective of the standard being audited, e.g., GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), GCP (Good Clinical Practice) or ISO (International Organization for Standardization). Generally four main audit time points may be identified during the course of a trial-facility, in-life, raw data and the fmal report.