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

Why “CDISC It”?

The decision to adapt to CDISC standards within an organization or for a particular clinical development program is not an easy one. Many large pharmaceutical companies have their own internal standards and tools built around those standards. For these companies, the decision about if and when to switch to CDISC was, and in many cases still is, fodder for heated debates. Upper management may cringe and balk at proposals to implement CDISC standards when they ...

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