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Implementing CDISC Using SAS by Jack Shostak, Chris Holland

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Chapter 1: Implementation Strategies

The Case for Standards

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

he Case for Standards

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

The Case for Standards

The decision to adapt to CDISC standards within an organization or for a particular clinical development program has gotten easier since Congress approved the FDA Safety and Innovation Act, or FDASIA, in July ...

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