Abstract
The utilization of Real-World Data (RWD) derived from existing clinical data is gaining attention. In Japan, the “Rinchu-Net” project, launched in 2018, leverages existing clinical data from Clinical Research Core Hospitals. These hospitals have developed infrastructure for multi-center collaborative research using RWD from electronic medical records. With the revision of ethical guidelines for life sciences and medical research in 2021, the centralization of ethics reviews for each study was required. Many institutions had to adapt to new operational practices, presenting challenges in ensuring a unified review format and understanding cross-institutional data provision procedures. The Rinchu-Net project created standardized research protocol templates and operational guidelines to facilitate smooth research implementation. To smoothly operate the unified ethics review stipulated by the new ethical guidelines, it was necessary to overcome practical challenges such as managing research ethics across multiple institutions and data provision logistics. The project aims to leverage the knowledge gained through Rinchu-Net to promote the distribution of medical information throughout Japan, further vitalizing medical data flow within the country.
