CDISC Primer

CDISC PRIMER NOW 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