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The development and analysis of a Japanese modern comprehensive clinical data management training program
Takuhiro Yamaguchi1,2,3, Hiroko Yaegashi2,4, Shih-Wei Chiu1,2
1Clinical Research Data Center, Tohoku University Hospital, Japan.
Heliyon
|March 28, 2024
Summary
This study developed an advanced clinical data management (CDM) training program for Japanese professionals. The program, covering risk-based monitoring and data standards, received high satisfaction ratings, indicating its effectiveness.
Area of Science:
- Clinical Research
- Data Management
- Professional Education
Background:
- Clinical data management (CDM) is crucial for clinical research, involving data collection, integration, and accessibility.
- Limited systematic training frameworks for CDM exist in Japanese academic research organizations.
- The effectiveness of existing Japanese-language CDM training requires further evaluation.
Purpose of the Study:
- To develop an advanced instructional program for clinical data management professionals.
- To assess the effectiveness of the developed CDM training program in a Japanese context.
Main Methods:
- An advanced CDM program was designed, incorporating risk-based monitoring and Clinical Data Interchange Standards Consortium (CDISC) principles.
- The program was piloted with clinical data managers to ensure a comprehensive understanding of CDM.
Main Results:
- Fifty-two professionals participated in the trial program.
- Participants reported high levels of satisfaction with the training content and delivery.
Conclusions:
- Continuous improvement of CDM training content and advanced program development are essential for comprehensive education in Japan.
- Competency-based educational programs need further enhancement due to evolving clinical research regulations and technological advancements.
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