CDISC Methodologies for FDA Submissions


WUSS Section Schedule
When: Wednesday, September 2, 2009
Where: Fairmont Hotel, San Jose, CA
 Room Hills Borough


2:00-2:30

2:30 - 3:00

3:00 - 3:30

3:30 - 4:00

4:00 - 4:30

4:30 - 5:00

5:00 - 5:30

5:30 - 6:00

6:00 - 6:30

Smoak: 
CDISC for the Medical Device and Diagnostic Industry: An Update

Brownley: Bridging CDASH to SAS: How Harmonizing Clinical Trial and Healthcare Standards May Impact SAS Users

Gerend: 
CDISC Implementation on an Rheumatoid Arthritis Project Partnership

Fleming: 
The Second CDISC Pilot Project: A Metastandard for Integrating Databases

Guo: 
Developing a SAS/IntrNet Tool to Detect Potential Drug-induced Liver Injury Using CDISC-standardized Data

Wood: 
The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics

 

  

    last updated on August 6.2009