Developing and implementing a comprehensive clinical QA audit program

Abstract

The Clinical Quality Assurance (CQA) audit program is a key element of a Good Clinical Practice (GCP) quality system. The objective of a CQA audit program is to ensure that trial conduct and data quality meet protocol-specified, GCP, and applicable regulatory requirements. Due to the increasing complexity of clinical trials and regulatory scrutiny, the components of a CQA audit program and the approaches taken towards designing and managing audits are constantly evolving. In this paper, we will focus on the strategies that are used to develop and implement a CQA audit program, including types of audits to be conducted and the quality approaches taken to manage and improve the CQA audit program. Copyright © 2008 John Wiley & Sons, Ltd.