CDISC PRIMER IN ENGLISH AND JAPANESE!
The only standards Primer written by CDISC!
- Outlines CDISC's aims and objectives
- Covers all the CDISC Standards
- Everything you need to know in one accessible text!
Japanese primer is available online only.
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