制定和实施全面的临床质量保证审核程序

Quality Assurance Journal Pub Date : 2007-06-01 DOI:10.1002/QAJ.420

Henry Li, Susan Hawlk, Kim Hanna, Gerald L. Klein, S. Petteway

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引用次数: 11

摘要

临床质量保证(CQA)审核程序是良好临床实践(GCP)质量体系的关键要素。CQA审核程序的目的是确保试验行为和数据质量符合协议规定、GCP和适用的法规要求。由于临床试验和监管审查的复杂性日益增加，CQA审核程序的组成部分以及用于设计和管理审核的方法不断发展。在本文中，我们将重点讨论用于开发和实施CQA审核程序的策略，包括要进行的审核类型以及用于管理和改进CQA审核程序的质量方法。版权所有©2008 John Wiley & Sons, Ltd

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Developing and implementing a comprehensive clinical QA audit program

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.

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Quality Assurance Journal

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