什么叫Note to File？
Note to File，有的称为File Note, 在中文里可以称为 "文件备忘录"、"备忘录"、"文件注释" 或 "记录备忘录"，具体的称呼可能会根据上下文和使用习惯有所不同。它通常用于记录和注释重要信息、事件、决策或观察，以便将来可以方便地查阅或追踪相关信息。
什么情况下使用note to file？
According to “SAM” Sather, Vice President of Clinical Pathways, “a note to file may be written by any member of a study team to provide additional information or clarification and can be used to explain how information was obtained and who obtained the information, discrepancies, missing and/or incomplete data, actions taken, and/ or measurements assigned.” A note to file, which can be patient or non-patient-related, may be used when other documentation is not adequate or not complete elsewhere. The situations in which a note to file can be used effectively in clinical research include, but are not limited to, the following文件注释可有效用于临床研究的情况包括但不限于:
To explain the location of a study document when it is not filed in the expected location, either on a temporary or permanent basis当研究文件未在预期位置存档时，解释研究文件的位置，无论是临时的还是永久的 (e.g., Enrollment Log file maintained at clinical research coordinator’s desk and not in the study file until the end of the study; Drug Accountability logs maintained in the pharmacy instead of study file; original accountability logs retained at the site and not collected by the sponsor due to policies of the site’s pharmacy).
To explain a discrepancy, the action taken in response, and the method adopted to prevent similar discrepancies解释差异、采取的应对措施以及防止类似差异的方法 (e.g., that all time stamps recorded from March 9-14, 2016 are off by one hour due to the site’s failure to adjust its clocks for the start of daylight savings time, and an indication that the clocks were adjusted by March 15, 2016).
To document the corrective action plan agreed upon by the research site for addressing non-compliance记录研究中心为解决不依从而商定的纠正措施计划. The document should have the following components: the issue, root cause, assigned intervention(s), and timeline for completion, and method of evaluation of effectiveness with timeline.
To clarify an instruction or direction regarding some activity required by the protocol, but that was not explained clearly in the protocol澄清方案要求但方案中未明确解释的有关某些活动的说明或指导 (e.g., elevated vital signs are not to be reported as an adverse event unless the elevation lasts longer than one hour).
Sather adds that notes to file are unnecessary when actions, clarifications, plans, or discrepancies are addressed fully in other study documentation当措施、澄清、计划或差异在其他研究文件中得到充分解决时，无需使用NTF (e.g., investigator corrective actions noted elsewhere and CRA follow-up letters). It is important to limit notes to file (NTF) whenever possible as discrepancies can exist between a NTF and other study documents, too many notes to file can raise concerns of auditors and regulatory inspectors over why there were so many issues with study procedures or study documentation.
-----摘自GCP Q&A Guide 2020/2021-Q6.13
编写Note to File时应注意的要点有哪些？
清晰和简洁：确保注释清晰明了，用简洁的语言表达。避免使用复杂或模糊的术语，以免引起误解。
包括关键信息：在注释中包括关键信息，如日期、作者、主题、相关文件或记录的引用等。这有助于建立注释的上下文。
详细描述：提供详细的描述，以便将来可以理解事件或情况的完整情境。尽量回答谁、什么、何时、为什么、如何等问题。
使用正式语言：在写作时使用正式的、专业的语言，避免使用俚语或口语表达。
保持客观：尽量保持客观，不要加入个人感情或偏见。注释应该是基于事实和观察的。
使用编号或标题：如果有多个 "note to file" 或注释，可以使用编号或标题来标识每一个，以便更容易管理和检索。
日期和时间戳：确保注释中包括日期和时间戳，以记录事件的发生时间。这有助于建立时间线。
签名和认证：如果需要，确保注释得到相关人员的签名和认证。
保密性和安全性：如果注释包含敏感信息，确保采取适当的安全措施来保护数据的机密性和完整性。
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