첨단바이오의약품 장기추적조사를 위한 전자증례기록서 표준안 개발 연구

초록

Advanced Therapy Medicinal Products (ATMPs), which are medicines for human use based on genes, tissues, or cells, are subject to a legal long-term followup (LTFU) framework established in Korea. Objective: (1) To link clinical data management (CDM) procedures with the LTFU workflow for ATMPs, and (2) to develop a standardized electronic case report form (eCRF) template designed for post-marketing surveillance of ATMPs. Methods: The LTFU workflow for ATMPs was reviewed based on Korea regulatory guidelines, and the CDM process was examined. The two frameworks were linked to clarify data collection and responsibilities across stakeholders. We defined a standardized codebook comprising structured variables and annotated eCRF fields based on terminology from the Clinical Data Interchange Standards Consortium (CDISC). Based on this structure, a reference eCRF template was developed using a representative cell-based gene therapy product. Results: The national LTFU workflow for ATMPs was linked to the CDM procedures by specifying how clinical data collection tasks correspond to operational responsibilities across stakeholders. A codebook was defined in accordance with the CDISC standards to define annotated data fields. Based on this codebook, a standardized eCRF template was developed covering key domains. Conclusion: This study established a structured linkage between Korea LTFU procedures for ATMPs and the CDM procedures and developed a standardized eCRF to enhance the structure and efficiency of data governance. The standardized and systematic approach to data acquisition through eCRFs is expected to ensure high data quality and reliability, ultimately contributing to increased public confidence in ATMPs. (PeRM 2025;17:237-245)

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