Robust tools to Create Define.xml v2.0 based submission Package

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nadmin March 6, 2024 0 Comments

In 2013 CDISC came out with define XML specification version 2.0. Unlike previous version 1.0, which was focused on SDTM, version 2.0 define.xml is designed equally well for SDTM, SEND and ADaM. Define.xml version 2.0 is now integrated with NCI controlled terminology and supports complicated Value-level metadata definitions. Previous define.xml tools for define.xml V1.0 are incompatible with newer define version and more systematic and sophisticated tools are needed to comply with define.xml V 2.0 specifications.

Attached paper presents unified metadata system to create define.xml version 2.0 for SDTM, ADAM or SEND data. Also additional tools are presented to use the same system to assist CRF annotation & create define.pdf. The system uses four standard metadata tables – one each for dataset, variables, value level and controlled terminology. The define.xml creation is split into two steps – creation of validated metadata datasets and using these to create define.xml. With use of validated metadata tables, define.xml creation becomes lean and issue-free. The detailed metadata specs are presented in the appendix.

The paper, corresponding presentation and several related files are can be requested at