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

Tenzin Kunga; Masataka Sano; Motoi Iwashita

doi:10.52731/iee.v5.i2.429

Tenzin Kunga Chiba Institute of Technology
Masataka Sano Chiba Institute of Technology
Motoi Iwashita Chiba Institute of Technology

DOI: https://doi.org/10.52731/iee.v5.i2.429

Keywords: Addendum, Clinical Trials, International Standard Organization, Quality Management System, International Council for Harmonization, Risk-Based Approach

Abstract

This article compares and analyzes the correlation between the GCP Integrated AddendumICH E6 (R2) protocols and Quality Management System (QMS) ISO 9001:2015 requirements for improving the clinical trials system. A 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 trial system. This study shows a 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.

Author Biographies

Tenzin Kunga, Chiba Institute of Technology

(Graduate student)

Master's in management Engineering,

Graduate School of Social System Science

Chiba Institute of Technology

Masataka Sano, Chiba Institute of Technology

Associate Professor,

Department of Management Information Science,

Chiba Institute of Technology,

Chiba, Japan

Motoi Iwashita, Chiba Institute of Technology

Professor,

Department of Management Information Science,

Chiba Institute of Technology,

Chiba, Japaassociate

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