Chapter 12: Other Topics

Standard for Exchange of Non-Clinical Data



Protocol Representation Model

FDA Janus Clinical Trials Repository

CDISC Model Versioning

Future CDISC Directions

Chapter Summary

This book has primarily focused on the use of SAS products for the creation and use of data that conforms to CDISC standards, specifically the SDTM and ADaM. In this chapter, we introduce you to other CDISC standards and related initiatives that have less of a direct impact on the typical roles of data managers, SAS programmers, and biostatisticians involved with clinical research. As a result, these standards and initiatives might have little to do with SAS software, at least for now. In the future, however, they could become ...

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