Open AccessStandard operating procedures in clinical research: a beginner's guide
Author(s) -
Hamrell Michael R.,
Wagman Bruce
Publication year - 2001
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/qaj.130
Subject(s) - standardization , clinical trial , quality (philosophy) , standard operating procedure , consistency (knowledge bases) , process management , quality management system , multinational corporation , engineering management , computer science , quality management , medicine , operations management , engineering , business , management system , philosophy , epistemology , pathology , finance , artificial intelligence , operating system
Abstract A consistent concern when implementing a quality system for clinical research is the level of standardization and organization to impose within each department. Standard operating procedures (SOPs) and operational guidelines (OGs), describing how each member of the clinical research team should conduct the various activities associated within their department, are the framework for any quality system. SOPs provide instructions and guidance to the user on what to do and what is expected of them. Standardized procedures are important not only to provide direct instruction but also to maintain consistency between various parts of an organization involved with the conduct and reporting of clinical trials. The increased use of multinational clinical trials requires the use of a standardized approach to maintain consistent quality and results in a drug development programme. In this article, an introduction to quality systems, SOPs and how they can help in the conduct of clinical trials, provides an overview for those persons new to clinical research and the role of SOPs. Copyright © 2001 John Wiley & Sons, Ltd.