A Quality Assurance Program for AIDS Clinical Trials Group Pharmacology studies

Abstract

The goal of the AIDS Clinical Trials Group (ACTG) Pharmacology Quality Assurance (QA) Program is to provide mechanisms that assure, in a timely manner, the validity and integrity of the data produced in pharmacology-related ACTG research protocols. In 2000, a new QA Program for ACTG Pharmacology Studies was strategized and implemented. By identifying the common problems and errors occurring within prior clinical studies and utilizing the quality procedures inherent within Good Clinical Practice (GCP) Regulations, Good Laboratory Practice (GLP) Regulations and the Clinical Laboratory Improvement Act (CLIA), specific program components were designed. The latter regulation, CLIA, is required for ACTG Pharmacology Support Laboratories (PSL) generating laboratory results directly impacting patient care. New pharmacology QA practices were implemented throughout the conduct of ACTG clinical trials. This document provides an overview of the present ACTG Pharmacology QA program. Copyright © 2005 John Wiley & Sons, Ltd.