IMPLEMENTATION OF CDISC STANDARDS

IMPLEMENTATION OF CDISC STANDARDS
Presented By Sandeep Raj Juneja, ASG Inc....




CDISC accomplishments and Strategy



CDISC and Standards for Clinical Research
by Rebecca D.Kush, Ph.D, Founder & President,CDISC
CDISC SDTM and related initativies



CDISC submission standard : CDISC SDTM_Basics
Supporting The CDISC Standards
By Mark Lambrecht,PhD, Principal Consultant,Life Sciences,SAS



Case Report Tabulation Data Definition Specification (define.xml)
CDISC Study Data Tabulation Model SDTM Implementation Guide V3.1.1
http://www.cdisc.org/models/sdtm/v1.1/index.html


Clinical Data Integration:
SAS Clinical Data Integration
By Dave Smith, SAS UK


Industry Standards for the electronic submission of Data to the FDA

by Michael A.Walega


CDISC SDTM Basics