IMPLEMENTATION OF CDISC STANDARDS
IMPLEMENTATION OF CDISC STANDARDS Presented By Sandeep Raj Juneja, ASG Inc.... CDISC accomplishments and Strategy CDISC an d 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 Th e 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