Competencies in an electronic trial master file used in clinical trials

Abstract

This study is an action research that combined theories and practices through change and reflection in a problematic situation in a real organization. A pilot research in an organizational case in Thailand indicated critical gaps in enterprise content management (ECM), called an electronic trial master file (eTMF), which resulted in challenges in eTMF implementation. The primary gap, in people's areas, was lack of competencies and performances. Therefore, the research objective following the gap identification was to enhance human capital that includes competencies and performances in the eTMF. The research combined the theories of human capital, the Fifth Discipline: shared vision, competency-based management, and practices in real organizations. A focus group and quantitative analysis approach were applied in this research. The research participants comprised 25 employees: the country manager, experts, the assistant, and users of the eTMF. The results presented the competencies in which user participation was critical for establishing the appropriate competencies to support the achievement of the performance. The competencies in the eTMF consisted of 3 dimensions comprising knowledge, skills, and attributes, with 11 competencies concerning the components in ECM and the specific organizational ECM context. This research contributed to the workplace, pharmaceutical industry, and academics by providing approaches to enhance human capital in ECM in case people were the primary area. The research contributed to the gap identification that guided the ways to improve performance in an ECM. In addition, this research proposed human capital management concepts by providing approaches to enhance human capital during the ECM adoption phase.