Chapter 1: Implementation Strategies
Starting with the Clinical Data Acquisition Standards Harmonization (CDASH) Standard
Implementation Plans and the Need for Governance
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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