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

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.