CDISC Primer

CDISC PRIMER NOW IN JAPANESE! PLEASE CONTACT CDISC DIRECTLY FOR MORE INFORMATION.

The only standards Primer written by CDISC!

• Stay up-to-date with new health and clinical research data standards development
• Chart your implementation course using the latest insights and best practices

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Contents

Preface,

Introduction,

The CDISC Standards,

The CDISC Clinical Research Glossary,

Protocol Representation,

Clinical Data Acquisition Data Standards Harmonization - CDASH,

The Operational Data Model - ODM,

The Clinical Laboratory Data Model - LAB,

Submission Data Standards: SDTM, SEND, Trial Design & Define.xml,

The Analysis Data Model - ADaM,

Standard Controlled Terminology,

The CDISC Healthcare Link Initiative,

The Biomedical Research Integrated Domain Group (BRIDG) Model,

The Future of CDISC Standards (The Technical Roadmap),

How to Start Implementing CDISC Standards,

The Future for CDISC,

Appendix