フォーラム
「Note to File」活用の課題と対策～医師主導治験の治験製造施設における逸脱事案を通じて～
2025 年 56 巻 6 号 p. 285-292
詳細
2025 年 56 巻 6 号 p. 285-292
Background: The definition and proper use of the “Note to File” (NTF) in clinical trials are ambiguous in Japan, leading to inconsistent application. While the use of NTFs is increasing, their overuse is a concern.
Objective: This study analyzes the challenges of NTF use, triggered by a case example in an investigator-initiated trial, to identify issues in current domestic and international practices, and aims to propose standardized handling of NTFs.
Methods: We reviewed global NTF definitions and usage, then analyzed NTF application in 325 clinical trials conducted at our hospital.
Results & Discussion: Internationally, NTFs are used to document root causes and corrective actions for irregular incidents. In Japan, they primarily function as supplementary records and were frequently used for operational and case record supplements. The lack of a standardized NTF format results in content variability and, in some cases, even includes critical issues that should have been addressed through formal processes.
Conclusion: We propose implementing standardized NTF formats and guidelines to ensure clear documentation of problems, causes, and resolutions. This is expected to improve the consistency and quality of clinical trial documentation.
