Implementing CDISC Using SAS, 2nd Edition

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

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 of 2012. As of December 2016, the implementation of CDISC standards, primarily the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM), is required for certain studies contained within FDA marketing applications. For the early ...