Special Instructions: You are required to bring your own laptop. Course materials will be emailed approximately one week prior to the session.
特别说明：参加培训时须携带手提电脑。课程资料将在培训开始前约一周通过邮件发送给您.
Facility Entry Requirements
Please plan to arrive by 8:30AM.
入场要求：
请于早上8:30前到达培训场地
NOTES:
-- This training will be conducted in Chinese. -- This class is limited to two persons per organisation. However, if space is available, please contact the MSSO training desk, mssotraining@meddra.org, for consideration to add registrants from your company.
备注:
-- 本次培训使用中文
-- 每个组织机构最多限报两人。如果有剩余席位，您可以发邮件至 MSSO 培训咨询台（mssotraining@meddra.org）申请增加本组织机构的名额，我们会根据实际注册情况考虑您的需求。
Objective:
For participants to review and understand the principles described in the MedDRA Data Retrieval and Presentation: Points to Consider document and to gain an understanding of how and why SMQs have been developed and to appreciate their utility when using databases of MedDRA-coded information.
目标:
认识和理解《MedDRA 数据检索和展示：考虑要点》文档中描述的原则，以及开发 SMQ 的方法和原因，了解 SMQ在以 MedDRA 编码信息的数据库中的用途。
Description:
This highly interactive 1-day course is designed to provide an overview of the features of MedDRA that relate to the analysis and retrieval of MedDRA-encoded data. The course focuses on the use of MedDRA to retrieve and present aggregated data, based on the principles outlined in the MedDRA Data Retrieval and Presentation: Points to Consider document. Participants will benefit from interactive individual and group exercises in which they will learn how to develop medically meaningful queries for use in their daily work. The course also includes a thorough overview of Standardised MedDRA Queries (SMQs) and their application in the investigation of drug safety issues. Participants learn about the development, testing and maintenance of SMQs and see detailed examples of individual SMQs. Examples of practical applications of SMQs for case identification, safety signal detection, product labeling review, and safety data reporting are presented.
描述：
本次课程时长一天。帮助您了解在对 MedDRA 编码的数据进行分析和检索时应当考虑的相关 MedDRA特征。本课程的重点在于根据《MedDRA 数据检索和展示：考虑要点》文档中描述的原则，对汇总数据进行检索和展示。参加者通过参与个体互动和分组练习，学习如何编写有医学意义的分析查询，并应用于日常工作。本课程还包括标准 MedDRA 分析查询（SMQ）的概述，及其在研究药物安全问题中的应用。参加者将了解 SMQ 的开发、测试和维护，详细学习几个 SMQ，并了解 SMQ 在病例识别、安全性信号侦测、产品标签审阅、以及安全性信息报告中的应用实例。
This course is designed for:
Course outline:
Drug safety/pharmacovigilance professionals Clinical monitors Medical writers Data coordinators Clinical programmers Statisticians MedDRA overview MedDRA Data Retrieval and Presentation: Points to Consider document Developing queries using MedDRA Examples and hands-on exercises SMQ background and definition SMQs development status SMQ data characteristics SMQ testing and production maintenance SMQ versioning SMQ applications Customised searches适合人群：
课程大纲：
药物安全/药物警戒人员
临床监察员
医学撰写人员
数据协调员
临床数据程序员
统计师
MedDRA 的概况
MedDRA 数据检索和展示：考虑要点文档
使用 MedDRA 编写分析查询
示例和练习
SMQ 的背景和定义
SMQ 的开发状态
SMQ 数据的特征
SMQ 测试和使用中的维护
SMQ 的版本更新
SMQ 的应用
定制搜索
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