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
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