DIA 48th Annual Meeting
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Operationalizing SDTM
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
360
Date:
Wednesday, June 27, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Gary Gensinger, FDA, United States
PRESENTER
(S):
Douglas Warfield, FDA, United States
Amy Malla, FDA, United States Dhananjay Chhatre, FDA, United States
Description
This session will provide practical advice and feedback to industry regarding submission of CDISC SDTM data to CDER and CBER. The session should allow sponsors to gain answers to common questions and issues that arise with SDTM submitted to FDA.
Learning Objectives:
Discuss the volume of SDTM being submitted to CDER and CBER
Describe the top issues that both Centers are encountering with SDTM
Describe the process each Center has for validating data and troubleshooting issues that may arise.
Learning Objectives:
Discuss the volume of SDTM being submitted to CDER and CBER
Describe the top issues that both Centers are encountering with SDTM
Describe the process each Center has for validating data and troubleshooting issues that may arise.
This session is a part of:
Handout Online
