Date and Time
THU, 9 AUG 2018, 10:00 AM - 11:30 AM Central Daylight Time
Define-XML transmits metadata that describes any tabular dataset structure. When used with the CDISC content standards, it provides the metadata for human and animal model datasets using the SDTM and/or SEND standards and analysis datasets using ADaM. Define-XML is required by the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for every study in each electronic submission to inform the regulators which datasets, variables, controlled terms, and other specified metadata were used.
The Define-XML team is releasing Define-XML Version 2.1 for a second public review. In the course of resolving comments during the first Public Review, which ran from March to May 2017, three significant changes were made to the standard in response to feedback received. These changes warrant a second public review and include:
1) Updated requirements for referencing the CDISC Standards and Controlled Terminology used in a study.
2) A new attribute for indicating when a dataset or variable has no data.
3) A new SubClass element and related changes to the dataset Class definition
Members of the development team will provide details about these changes and describe how they will benefit Define-XML users.
Webinar Language
English
Presenters
- Sally Cassells, Next Step Clinical Systems, Owner/President
- Sam Hume, CDISC, VP of Data Science
- Marcelina Hungria, DIcore Group, Consultant/Owner
- Lex Jansen, SAS Institute, Principal Software Developer
- Monika Kawohl, HMS Analytical Software GmbH, Principal Statistical Programmer
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