临床试验-研究文件说明（NTF）编写指南

非原创文件，仅供业内分享学习

Guidelines for Writing Notes to the Study File

研究文件说明编写指南

Notes to the Study File are written to identify a discrepancy or problem in the conduct of the clinical research study, note the root cause of the identified problem, identify the corrective action taken to prevent recurrence of the problem, and document that the corrective action has resolved the problem. In general, the tone of the note should be forward-looking and not seek to explain an error discovered in the conduct of a clinical research study. For example, a Note to Study File may be appropriate to: 研究文件说明是用于辨别临床研究过程中存在的差异或问题，记录问题的根本原因，确定防止问题复发的纠正措施，并记录措施已解决问题。一般来说，研究文件说明应具有前瞻性，而不是试图解释在进行临床研究时发现的错误。例如，研究文件说明可适用于以下情况：

▪         Clarify or add information regarding site-specific regulatory file requirements 说明或添加有关特定中心管理文件要求的信息

▪         Clarify or add information regarding source document standards 说明或添加有关源文档标准的信息

▪         Document and address any issue that is protocol- and/or site-specific and that cannot be resolved without a change from previous procedures. 记录和定位任何

关于协议和/或中心的问题，如果不更改此前的流程，这些问题将无法得到解决

A Note to the Study File should be printed on institution letterhead and should be initiated and authored by the individual or organization responsible for its content, as

follows: 研究文件说明应以机构抬头印刷，并应由负责研究文件内容的个人或组织发起和撰写，内容如下：

▪       If the issue relates to site performance, the appropriate credentialed individual

from the site should write and sign the note to file. 如果问题与中心执行情况有关， 则由中心对应的人员编写并签署该说明

▪         If the issue relates to principal investigator (PI) responsibilities (e.g., human subject protection, data integrity at the site), the PI should write and sign the note

to file. 如果问题涉及主要研究者(PI)的职责(例如，保护受试者的人身安全、中心数据的完整性)，则 PI 应在说明上签字

▪         If the issue relates to actions taken by the sponsor or monitor (e.g., clarification of a protocol section), an appropriate credentialed individual from the sponsor

should write and sign the note to file. 如果该问题与申办方或监查员所采取的行动有关(例如，对合同部分的说明)，则应由申办方对应的人员编写并签署该说明。

Retention and Distribution 保存和发送

All Notes to the Study File should be signed by the author, kept on file in the site regulatory file, and made available to the clinical site monitors reviewing the site’s documents and procedures. 所有研究文件说明均应由撰写者签署，并保存在中心管理文件中，以便临床机构监查员复核该中心的文件和流程。

Please send a scanned PDF of all signed Notes to the Study File as an e-mail attachment to the NCCIH point of contact for the clinical research study and the OCRA staff contact. The clinical site monitor will retrieve a copy of the memo as needed, based on the significance of issues addressed in the memo. 请将所有已签署的说明扫描成

PDF 格式，作为电子邮件附件发送到 NCCIH 临床研究联系人和 OCRA 联系人。临床中心监查员将根据说明中所述问题的重要性，根据需要留存说明的副本。

In addition, if a data management center (DMC) is handling the data management of the clinical research study, please forward a copy to the DMC. 此外，如果数据管理中心

(DMC)正在处理临床研究的数据管理，请转发一份副本给 DMC。

Note to the Study File Template

研究文件说明模板

The following page provides a template for the content and format of a Note to the Study File. Text enclosed with <> is a placeholder for a specific detail (e.g., <protocol number>); replace as appropriate. 以下内容是研究文件说明的内容和格式模板。带有<> 符号的文字是对应内容的占位字符（例如，<协议数量>），请根据情况填写。

<Institution Letterhead 机构抬头>

Date:            <Date that the Note to the Study File is written 书写研究文件说明的日期>

To:                <NCCIH protocol number followed by “Study File”NCCIH 协议编号，后接“Study File”>

From             <Name, title, and site or institutional affiliation of person authoring the Note to the Study File, and this individual’s signature 名称，标题，研究文件说明作者的中心或所属机构，作者署名>

Issue:     <Brief description or outline of the topic/process/problem being documented; can be formatted as a paragraph, numbered list, or bulleted items>记录的关于主题/流程/问题 的简要描述或概括，可统一为段落、数字列表、或项目列表格式

Root Cause:     <The reason(s) that the issue arose 引发问题的原因>

Corrective Actions:     Description of the corrective actions taken or planned

by the site personnel. If the site was instructed to perform these corrective actions (i.e., by the sponsor or monitor), indicate by whom and as of what date. If status of reports, records, or data will remain incomplete or unavailable, make a statement regarding your failed attempts or describe when/how the records will be retrieved or completed. 描述中心工作人员已采取或计划采取的纠正措施。如果中心收到这些措施的执行指令（比如来自申办方或监查员的指令），说明指令的下达人，及下达时间。如果报告、记录或数据不完整或不可用，请说明你为此做出过的未成功的补救措施，或描述该记录将在何时/如何得到恢复或完善。>

Resolution:     <Description of the procedures used to document resolution of the problem 关于记录问题解决流程的描述>

Effective Date of

Resolution:     <Effective date for corrective action (may be the same date as in the memo header)纠正措施的生效日期（可能与备忘录日期相同）>

Comments:     <Any additional comments or information not noted above 以上未提及的任何补充内容或信息>