The development and analysis of a Japanese modern comprehensive clinical data management training program
Takuhiro Yamaguchi,
Hiroko Yaegashi,
Shih-Wei Chiu,
Yukari Uemura,
Takuya Kawahara,
Tempei Miyaji,
Tomoe Mashiko,
Munenori Takata
Affiliations
Takuhiro Yamaguchi
Clinical Research Data Center, Tohoku University Hospital, Japan; Division of Biostatistics, Tohoku University Graduate School of Medicine, Japan; Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Japan; Corresponding author. Clinical Research Data Center, Tohoku University Hospital, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan.
Hiroko Yaegashi
Division of Biostatistics, Tohoku University Graduate School of Medicine, Japan; A2 Healthcare Corporation, Japan
Shih-Wei Chiu
Clinical Research Data Center, Tohoku University Hospital, Japan; Division of Biostatistics, Tohoku University Graduate School of Medicine, Japan
Yukari Uemura
Center for Clinical Sciences, National Center for Global Health and Medicine, Japan
Takuya Kawahara
Clinical Research Promotion Center, The University of Tokyo Hospital, Japan
Tempei Miyaji
Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Japan
Tomoe Mashiko
Suxac Inc., Japan
Munenori Takata
Clinical Research Data Center, Tohoku University Hospital, Japan; Division of Biostatistics, Tohoku University Graduate School of Medicine, Japan
Background: Clinical data management (CDM) collects, integrates, and makes data available. It plays a vital role in clinical research. However, there are few opportunities for Japanese clinical data managers to learn about its systematic framework, particularly in academic research organizations. While Japanese-language CDM training exists, its effectiveness in a Japanese context requires clarification. Objectives: We aimed to develop an advanced program of instruction for professionals to understand CDM and to determine the effectiveness of the training program. Methods and results: We developed an advanced program including risk-based monitoring and the Clinical Data Interchange Standards Consortium on a trial basis for clinical data managers to provide them with a comprehensive understanding of CDM. Fifty-two people attended the program and reported that they were highly satisfied with it. Conclusions: To provide comprehensive CDM training in Japan, it is imperative to continue improving the content and develop an advanced program. Due to the recent tightening of clinical research regulations and the development and dissemination of various systems for conducting clinical research, the competency-based educational program requires further development.
