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

Where Clause Metadata

Computational Method Metadata

Comments Metadata

External Links

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, which creates an 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 call to the SAS macro using the SDTM metadata that is stored in Microsoft Excel to create the define.xml file.

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