WHO《数据完整性指南》-2021（中英文对照版）
3月29日，WHO发布了第 55 届药物制剂规范专家委员会（ECSPP）技术报告TRS No.1033，其中包含新的《数据完整性指南》，翻译如下，分享给大家！
Guideline on data integrity
数据完整性指南
1. Introduction and background
介绍和背景
1.1. In recent years, the number ofobservations made regarding the integrity of data, documentation and recordmanagement practices during inspections of good manufacturing practice (GMP) (2),good clinical practice (GCP), good laboratory practice (GLP) and Good Trade andDistribution Practices (GTDP) have been increasing. The possible causes forthis may include
近年来，在对良好生产规范(GMP)(2)、良好临床规范(GCP)、良好实验室规范(GLP)和良好贸易和分销规范(GTDP)的检查过程中，对数据完整性、文件和记录管理规范的缺陷数量持续增加。可能的原因包括：
(ⅰ) reliance on inadequate human practices;
依赖于不适当的人员操作;
(ⅱ)poorly defined procedures;
规定糟糕的规程
(ⅲ)resource constraints;
资源限制
(ⅳ) the use of computerized systems that are not capable of meetingregulatory requirements or are inappropriately managed and validated (3, 4);
使用不满足法规要求，或管理/验证不当的计算机系统(3,4);
(ⅴ) inappropriate and inadequate control of data flow; and
不适当和不充分的数据流控制;和
(ⅵ)failure to adequately review and manage original data and records.
未能充分审核和管理原始数据和记录。
1.2. Data governance and related measures shouldbe part of a quality system, and are important to ensure the reliability ofdata and records in good practice (GxP) activities and regulatory submissions.The data and records should be 'attributable, legible, contemporaneous,original’ and accurate, complete, consistent, enduring, and available; commonlyreferred to as “ALCOA+”.
数据治理和相关措施应该是质量体系的一部分，对于确保GxP活动和法规申报中的数据和记录的可靠性非常重要。数据和记录应是“可归属的、易读的、同步的、原始的”、准确的、完整的、一致的、持久的和可用的;通常称为“ALCOA+”。
1.3. This document replaces the WHO Guidanceon good data and record managementpractices (Annex 5, WHO Technical Report Series, No. 996, 2016) (1).
本文件取代了《WHO良好数据和记录管理规范指南》(WHO技术报告系列，No. 996, 2016，附件5)(1)。
2. Scope
范围
2.1. This document provides information,guidance and recommendations to strengthen data integrity in support of productquality, safety and efficacy. The aim is to ensure compliance with regulatoryrequirements in, for example clinical research, production and quality control,which ultimately contributes to patient safety. It covers electronic, paper andhybrid systems.
本文件提供了用以巩固数据完整性的信息、指南和建议，以支持产品质量、安全性和有效性。目的是确保在临床研究、生产和质量控制等方面符合法规要求，保证患者安全。它涵
盖了电子，纸张和混合系统。
2.2. The guideline covers ”GxP” for medicalproducts. The principles could also be applied to other products such as vectorcontrol products.
本指南涵盖了医药产品 “GxP”。这些原则也可应用于其他产品，如病媒控制产品。
2.3. The principles of this guideline alsoapply to contract givers and contract acceptors. Contract givers are ultimatelyresponsible for the integrity of data provided to them by contract acceptors.Contract givers should therefore ensure that contract acceptors have theappropriate capabilities and comply with the principles contained in thisguideline and documented in quality agreements.
本指南的原则也适用于委托方和受托方。委托方对受托方提供给他们的数据的完整性负有最终责任。因此，委托方应确保受托方具有适当的能力，并遵守本指南和质量协议中所包含的原则。
2.4. Where possible, this guideline hasbeen harmonised with other published documents
on data integrity. Thisguideline should also be read with other WHO good practices guidelines andpublications including, but not limited to, those listed in the referencessection of this document.
本指南已尽可能与其他公布的数据完整性文件相协调。本指南还应与WHO其他良好规范指南和出版物一起阅读，包括但不限于本文件参考章节中所列的内容。
3. Glossary
术语
The definitions given below apply to theterms used in these guidelines. They may have different meanings in othercontexts.
以下给出的定义适用于本指南中使用的术语。它们在其他环境可能有不同的含义。
ALCOA+. governance
A commonly used acronym for “attributable,legible, contemporaneous, original and accur
ate” which puts additional emphasison the attributes of being complete, consistent, enduring and availablethroughout the data life cycle for the defined retention period.
Archiving.
归档
Archiving is the process of long-termstorage and protection of records from the possibility of deterioration, andbeing altered or deleted, throughout the required retention period. Archivedrecords should include the complete data, for example, paper records,electronic records including associated metadata such as audit trails andelectronic signatures. Within a GLP context, the archived records should be underthe control of independent data management personnel throughout the requiredretention period.
Audit trail.
审计追踪
The audit trail is a form of metadatacontaining information associated with actions that relate to the creation,modification or deletion of GxP records. An audit trail provides for a securerecording of life cycle details such as creation, additions, deletions oralterations of information in a record, either paper or electronic, withoutobscuring or overwriting the original record. An audit trail facilitates thereconstruction of the history of such events relating to the record regardlessof its medium, including the “who, what, when and why” of the action.

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