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Development of a Good Clinical Practice inspection checklist to assess clinical trial sites in Vietnam

BMJ open, 2021-07, Vol.11 (7), p.e048256-e048256 [Peer Reviewed Journal]

Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. ;2021 Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. 2021 ;ISSN: 2044-6055 ;EISSN: 2044-6055 ;DOI: 10.1136/bmjopen-2020-048256 ;PMID: 34312203

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  • Title:
    Development of a Good Clinical Practice inspection checklist to assess clinical trial sites in Vietnam
  • Author: Nguyen, Quang Ngo ; Nguyen, Nam Vinh ; Nguyen, Dung Thi Phuong ; Vidaillac, Celine ; Trinh, Phuong Thi Minh ; van Doorn, H Rogier ; Thwaites, Guy E ; Kestelyn, Evelyne ; Vo, Ha Thi Nhi
  • Subjects: Bans ; Clinical medicine ; Clinical trials ; Compliance ; Ethics ; Feedback ; Global Health ; Human resources ; Infrastructure ; International organizations ; Legal documents
  • Is Part Of: BMJ open, 2021-07, Vol.11 (7), p.e048256-e048256
  • Description: BackgroundAssessing the capacity of a healthcare institution to conduct and manage clinical research studies is challenging, especially in developing countries where resources are limited. The objective of this study was to develop a practical and transparent tool for the Vietnam Ministry of Health (MOH) to assess institutions’ capacity to lead clinical trials in line with local and international regulations.MethodsWe reviewed the literature, relevant official international and national guidelines, regulations and checklists for clinical sites’ assessment to identify key indicators of clinical research capacity. We developed a Good Clinical Practice (GCP) inspection checklist consisting of a questionnaire with 30 key criteria, including 16 core criteria and 14 recommended criteria, related to four central aspects of clinical research management (ie, governance, operations, infrastructures and human resources). Following a detailed review and assessment by a panel of experts, sponsors and academic investigators, we assessed the checklist’s applicability in a pilot study involving 10 sites with various clinical research experiences.ResultsIndependently of their clinical research experience, all participating institutions fulfilled most of the core criteria. In contrast, a significant variability was observed in the compliance to recommended capacity criteria, especially those related to governance (certifications and reporting) as well as operations (existence of a clinical research coordination unit or electronic trial management system).ConclusionsA GCP inspection checklist was successfully developed to support the MOH in the assessment of institutions’ capacity to conduct clinical research. Additional efforts from all stakeholders are now warranted to provide local sites with sustainable capacity development resources that will further build up and harmonise Vietnamese clinical research settings.
  • Publisher: London: BMJ Publishing Group LTD
  • Language: English
  • Identifier: ISSN: 2044-6055
    EISSN: 2044-6055
    DOI: 10.1136/bmjopen-2020-048256
    PMID: 34312203
  • Source: ProQuest One Psychology
    BMJ Open Access Journals
    Geneva Foundation Free Medical Journals at publisher websites
    PubMed Central
    ROAD: Directory of Open Access Scholarly Resources
    ProQuest Central
    DOAJ Directory of Open Access Journals
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