Implementing CDISC Using SAS® - Implementing CDISC Using SAS [Book]

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Contents

About This Book

About The Authors

Acknowledgments

Chapter 1: Implementation Strategies

Why “CDISC It”?

Which Models to Use and Where

Starting with the Clinical Data Acquisition Standards Harmonization (CDASH) Standard

Implementation Plans and the Need for Governance

SDTM Considerations

ADaM Considerations

Chapter Summary

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

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

Chapter 3: Implementing the CDISC SDTM with Base SAS

Base SAS Macros and Tools for SDTM Conversions

Creating an SDTM Codelist ...

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