Clinical research education: a mini-review of the available opportunities for future and current clinical trial managers

<p class="abstract">Various for-profit as well as not-for-profit organizations offer educational opportunities for project managers. Often, these are generic (not industry-specific) as the goal is to attract a wide audience of students. Examples include Six Sigma and the Project Management Professional ® program. Although students may be granted an opportunity to research their own industry as part of the curriculum, these programs generally do not focus on clinical research project management skills in particular. Therefore, it can be difficult for Clinical study managers/clinical project managers, and others within the clinical research field, to find appropriate training opportunities. This aim of the study was to provide valuable information on some of the primary available educational opportunities that exist for those entering the clinical research management workforce, or who are otherwise interested in expanding their knowledge in this field.</p>

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

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.