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The release of SDTM v1.7/SDTMIG v3.3 brought significant changes and newly added content, reflecting the increasing changing requirements on clinical study data standards from industry, regulatory agencies and other stakeholders over the past several years. This webinar aims to provide a thorough understanding of SDTMv1.7/SDTMIG v3.3 so that users are well-prepared for implementation.
Topics include:
- Highlights of SDTM v1.7 and SDTMIG v3.3
- Comparison between SDTMv1.4/SDTMIGvv3.2 and SDTM v1.7/SDTMIG v3.3
- Considerations on implementation strategy
标题：CDISC数据标准更新：SDTM1.7/SDTMIG3.3介绍
简介：
最新的SDTM标准SDTM1.7 / SDTMIG3.3已于2018年11月20日正式发布，相较于5年前发布、目前广泛使用的SDTM1.4 / SDTMIG3.2标准，本次更新涵盖许多新的内容和变化，以适应行业、监管当局及其他利益相关方等对临床研究数据标准化与时俱进的要求。
本次网络研讨会的目的是帮助您更好地了解这一新版本，为即将的具体实施作好准备，主要包括以下三个主要部分：
• SDTM1.7和SDTMIG3.3亮点介绍
• SDTM1.4 / SDTMIG3.2和SDTM1.7 / SDTMIG3.3比较
• 关于具体实施策略的考虑
Presenters
Stanley Wei, CDISC SDTM Instructor
Victor Wu, C3C Chair, Data Science
John Wang, C3C Vice Chair, dMed
Presenters
- Stanely Wei, CDISC SDTM Instructor
- John Wang, C3C Vice Chair, dMed
- Victor Wu, C3C Chair, Beijing Data Science Express Consulting Co., Ltd.