Date and Time:
FRI 19 APR 2019 @ 10:00 AM - 11:00 AM China Standard Time | THU 18 APR 9:00 PM - 10:00 PM Central US Standard Time

Description:
Define-XML is the metadata to describe study data (SDTM/ADaM) and ARM is the metadata to describe the tables or figures. Through structured representation, this type of metadata shows the data flow from raw data to analysis table or figure results, and provides clear data definition to regulatory reviewers.

By introducing the structure and related elements of Define-XML (ARM) as well as the development steps, review details, and implementation process in Chinese studies, this webinarwill address implementation recommendations and common implementation issues with the goal of further promoting the application of Define-XML in Chinese studies.

Define-XML是描述临床研究数据集(SDTM/ADaM)的元数据,ARM则是描述表格或图表的元数据。这类元数据通过结构化的表述,清晰呈现了从原始数据集到分析图表的数据流演变,为评审者提供清晰的数据定义。

通过介绍Define-XML(ARM)的结构及相关元素,制作生成步骤,检查审阅细节,中文项目实施建议及常见问题等,我们希望能够进一步推进Define-XML在中国项目上的实施与应用。

Panelists:
John Wang, AD, dMed
Victor Wu, VP, Data Science Express
Ruiling Peng, CEO, Improve Quality
 

Webinar Language: English

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