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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.
Presenters
- Sally Cassells, Owner/President, Next Step Clinical Systems
- Marcelina Hungria, Owner/Consultant, DIcore Group
- Monika Kawohl, Principal Statistical Programmer, HMS Analytical Software GmbH
- Lex Jansen, Principal Software Developer, SAS Institute
- Sam Hume, VP of Data Science, CDISC