Novel Approaches to Improving the Quality of the Clinical Trial System through a Directional Comparative Study

Abstract

This article compares and analyzes the correlation between the GCP Integrated Addendum-ICH E6 (R2) protocols and Quality Management System (QMS) ISO 9001:2015 requirements for improving the clinical trials system. Comparative analysis is a directional approach, created from the clinical trial guideline (ICH E6 (R2)-addendum) toward the ISO 9001:2015 quality standards. This directional perspective will allow a more accurate comparison and help identify any gaps that might exist in order to achieve quality performance in clinical trial practice. This paper concludes that the addendum mainly focuses on the risk-based approach. This approach, a perspective from the clinical trials and quality management system, can examine and find novel ways to improve the efficiency of the clinical trials system. This study shows directional perspective on and comparative analysis between the clinical trial guidelines (ICH E6 (R2)-addendum) and the ISO 9001:2015 quality standards in this domain, there is no prior research in this direction for Addendum.