JPMA Committee Activities Mapping List of Clinical Trial-related Documents, etc. in Japan to the Trial Master File Reference Model Ver. 3.3.1 (December 2025 Revised Version)
We have created a mapping list that maps to the TMF Reference Model the documents considered important in PMDA’s GCP on-site inspections and document-based compliance assessments. This enables management of documents subject to routine compliance assessment and is expected to contribute to risk-based approaches. Furthermore, it can be used as a reference for mapping TMF data transfers between companies. We hope this deliverable will be utilized by a wider range of stakeholders to further improve the efficiency and quality of TMF management at each company.
