TL13: Awareness and Implementation of CDISC Standards
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*Stephen Wilson, FDA/CDER/OTS/OB/DBIII 


Some of the CDISC standards have been recommended since 2004 but the industry has faced challenges in implementing them due to resource and other constraints. The implementation part has been a challenge especially for smaller companies. In this discussion, participants will share their thoughts on what challenges have been faced within their organization and how these hurdles have been addressed. The FDA participants will highlight the background and efficiency gained by using CDISC standards. Examples including (but not limited to) SDTM, ADAM based on recent experience by attendees will be also shared. Overall, a common vision and the path being taken by various entities will be the focus of this discussion.