CDISC Methodologies for FDA Submissions
BRIDGing CDASH to SAS: How Harmonizing Clinical Trial and Healthcare Standards May Impact SAS Users
Clinton Brownley (independent statistical consultant)
CDISC Implementation on a Rheumatoid Arthritis Project Partnership
Patricia Gerend (Genentech, Inc.), Chris Price, Oliver LeConte (Roche Products Limited), Michelle Zhang (Genentech, Inc.)
How a SAS/IntrNet tool was created at the FDA for the detection of potential drug-induced liver injury using data with CDISC standard
Ted Guo, John Senior, Kate Gelperin (FDA)
CDISC for the Medical Device and Diagnostic Industry: An Update
Carey Smoak (Roche Molecular Systems, Inc.)
The Second CDISC Pilot Project: A Metastandard for Integrating Databases
Gregory Steffens (Eli Lilly & Co.), Ian Fleming (Genentech, Inc.)
The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics
Fred Wood (Octagon Research Solutions, Inc.)
Table of contents
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