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Final WHO Guidance Document on Good Data andRecord Management Practices WHO关于优良数据和记录管理规范的指南定稿 我们最近通告了WHO起草关于优良数据和记录管理规范指南的新闻。现在WHO刚刚发布了此重要指南的最终版本。 l The final versionis sectioned rather similar to the draft version: l 最终版本章节划分与草案版本很相似： - Introduction 概述 - Aims and objectives of this guidance 本指南的目标 - Glossary 术语 - Principles 原则 - Quality risk management to ensure good datamanagement 确保优良数据管理的质量风险管理 - Management governance and quality audits 管理和质量审计 - Contracted organizations, suppliers andservice providers 合同组织供应商和服务提供方 - Training in good data and record management 优良数据和记录管理的培训 - Good documentation practices 优良文件规范 - Designing and validation systems to assuredata quality and reliability 设计和验证系统以确保数据质量和可靠性 - Managing data and records throughout the data lifecycle 在整个数据生命周期中管理数据和记录 - Addressing data reliability issues 数据可靠性问题说明 - References and further reading 参考文献和延伸阅读 Although the individual chapters were kept ratherunchained the content of these chapters was updated throughout the wholedocument. 尽管个别章节关联不紧，但这些章节的目录已进行了更新。 For instance the term "good documentationpractices" has now been expanded to "good data and recordmanagement practices" and is defined as follows in the glossary: 例如，术语“优良文件记录规范”已经扩展到“优良数据和记录管理规范”，在术语中定义如下： "The totality of organized measures that should bein place to collectively and individually ensure that data and records aresecure, attributable, legible, traceable, permanent, contemporaneouslyrecorded, original and accurate and that if not robustly implemented can impacton data reliability and completeness and undermine the robustness ofdecision-making based upon those data records." “应该具备有组织的措施，从单个和总体的角度来确保数据和记录是安全的、可归属到操作人员的、清楚的、可追溯的、永久的、同步记录的、原始的和准确的。如果不严谨的实施，就可能对数据可靠性和完整性形成影响，动摇基于这些数据记录所做的决策的说服力”。 Some of the former content has been put into Appendix 1now: Here you can find expectations and examples of special risk managementconsiderations for the implementation of ALCOA (-plus) principles in paper-basedand electronic systems. The tables in this appendix provide further guidance onthe implementation of the general ALCOA requirements. In addition, examples ofspecial risk management considerations as well as several illustrative examplesare provided of how these measures are typically implemented. 之前的一些内容已经被放到了附录1中。这里我们可以找到在纸质系统和电子系统中实施ALCOA+原则时特殊风险管理考虑的期望和例子。另外，还提供了特殊风险管理考虑的例子以及几个图解例子，说明这些措施一般是如何实施的。 However, these examples should not be taken as settingnew normative requirements. 但是，这些例子不应该作为是设定了新的强制要求。 更多信息参见WHO指南。
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