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Implementing CDISC Using SAS by Jack Shostak, Chris Holland

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Chapter 2: SDTM Metadata and Define.xml for Base SAS Implementation

SDTM Metadata

Table of Contents Metadata

Variable-Level Metadata

Codelist Metadata

Value-Level Metadata

Computational Method Metadata

Building define.xml

Define File Header Metadata

Define File Creation SAS Program

Chapter Summary

This chapter provides the SDTM metadata required to implement our Base SAS solution to creating a SDTM database. Microsoft Excel files are used to store the SDTM metadata that the SAS code presented in Chapter 3 will leverage to create the SDTM datasets. The chapter ends with a SAS macro using the SDTM metadata that is stored in Microsoft Excel to create the define.xml file.

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Appendix B - SDTM Metadata

Appendix D - %make_define SAS ...

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