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Survey of Risk-Based Quality Management Status and Establishment of Operational Model in Clinical Trials

PURPOSE: With the release of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use E6 addendum, it is very important to establish risk-based quality management systems which meet good clinical practice. The aim of this research was to propose for ris...

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Autores principales: Kim, EunHee, Lim, Chiyeon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Yonsei University College of Medicine 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214110/
https://www.ncbi.nlm.nih.gov/pubmed/32390366
http://dx.doi.org/10.3349/ymj.2020.61.5.423
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author Kim, EunHee
Lim, Chiyeon
author_facet Kim, EunHee
Lim, Chiyeon
author_sort Kim, EunHee
collection PubMed
description PURPOSE: With the release of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use E6 addendum, it is very important to establish risk-based quality management systems which meet good clinical practice. The aim of this research was to propose for risk-based quality management practices in the organizations that conduct clinical trials in South Korea. MATERIALS AND METHODS: The survey participant pool consisted of domestic or multinational pharmaceutical companies and fullservice clinical research organizations operating in South Korea that had one or more clinical trials approved by the Korean Ministry of Food and Drug Safety in 2018. RESULTS: Of the 97 selected companies, a total of 61 companies completed the survey. A total of 42 companies (68.9%) had employees designated to quality management activities. The minimum and maximum numbers of dedicated personnel for quality management were one and 12, respectively, and the average was three. Regarding the role of quality management personnel in companies, standard operating procedure management, issue/corrective action and preventive action (CAPA) management, and preparing inspection were selected the most (81%). The system considered to be the most important for risk management was monitoring system (41 companies, 67.2%), followed by both vendor management and CAPA management systems (17 companies, 27.9%). CONCLUSION: In the future, organizations conducting clinical and subsequent pilot studies trials in South Korea should follow these quality management practice to share information with each other.
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spelling pubmed-72141102020-05-18 Survey of Risk-Based Quality Management Status and Establishment of Operational Model in Clinical Trials Kim, EunHee Lim, Chiyeon Yonsei Med J Original Article PURPOSE: With the release of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use E6 addendum, it is very important to establish risk-based quality management systems which meet good clinical practice. The aim of this research was to propose for risk-based quality management practices in the organizations that conduct clinical trials in South Korea. MATERIALS AND METHODS: The survey participant pool consisted of domestic or multinational pharmaceutical companies and fullservice clinical research organizations operating in South Korea that had one or more clinical trials approved by the Korean Ministry of Food and Drug Safety in 2018. RESULTS: Of the 97 selected companies, a total of 61 companies completed the survey. A total of 42 companies (68.9%) had employees designated to quality management activities. The minimum and maximum numbers of dedicated personnel for quality management were one and 12, respectively, and the average was three. Regarding the role of quality management personnel in companies, standard operating procedure management, issue/corrective action and preventive action (CAPA) management, and preparing inspection were selected the most (81%). The system considered to be the most important for risk management was monitoring system (41 companies, 67.2%), followed by both vendor management and CAPA management systems (17 companies, 27.9%). CONCLUSION: In the future, organizations conducting clinical and subsequent pilot studies trials in South Korea should follow these quality management practice to share information with each other. Yonsei University College of Medicine 2020-05-01 2020-04-24 /pmc/articles/PMC7214110/ /pubmed/32390366 http://dx.doi.org/10.3349/ymj.2020.61.5.423 Text en © Copyright: Yonsei University College of Medicine 2020 https://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Kim, EunHee
Lim, Chiyeon
Survey of Risk-Based Quality Management Status and Establishment of Operational Model in Clinical Trials
title Survey of Risk-Based Quality Management Status and Establishment of Operational Model in Clinical Trials
title_full Survey of Risk-Based Quality Management Status and Establishment of Operational Model in Clinical Trials
title_fullStr Survey of Risk-Based Quality Management Status and Establishment of Operational Model in Clinical Trials
title_full_unstemmed Survey of Risk-Based Quality Management Status and Establishment of Operational Model in Clinical Trials
title_short Survey of Risk-Based Quality Management Status and Establishment of Operational Model in Clinical Trials
title_sort survey of risk-based quality management status and establishment of operational model in clinical trials
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214110/
https://www.ncbi.nlm.nih.gov/pubmed/32390366
http://dx.doi.org/10.3349/ymj.2020.61.5.423
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