What question did this study set out to answer?

The research aims to assess the current status and challenges in implementing CDISC standards within Japanese academic medical centers.

March 14, 2026Open Access

Current Status, Challenges, and Opportunities Associated With Implementing Clinical Data Interchange Standards Consortium Standards in Japanese Academic Medical Centers: Cross-Sectional Survey

Key Points

The research aims to assess the current status and challenges in implementing CDISC standards within Japanese academic medical centers.
Cross-sectional survey conducted among medical centers in Japan.
Assessment of resource availability and personnel expertise.
Evaluation of opportunities for collaboration with industry stakeholders.
Limited implementation of CDISC standards due to resource shortages.
High demand for support exposed a gap in specialized personnel.
Collaboration between academic and industry can enhance training and resource provision.

Abstract

The implementation of CDISC standards in Japanese academia is limited, primarily due to resource shortages and a lack of specialized personnel. However, the discrepancy between the high demand for support and limited supply highlights a significant opportunity. Experienced academic research organizations, in cooperation with pharmaceutical companies and contract research organizations, can drive nationwide adoption by taking a strategic leadership role in providing educational resources and training, thereby addressing the critical shortage of specialized personnel and know-how.

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