Monday, July 20, 2009

CDISC Panel Discussion

I have been invited to host and moderate a panel discussion at the next Western Users of SAS Software (WUSS) conference in San Jose. This will be in the CDISC section so we will be discussing meta data. I will share with you some general information about the discussion below.

Title
DEFINE.XML - A Practical Hands on Real World Experiences on Data Definition

Date Wednesday, September 2, 2009
Time 5:30-6:30pm
Where Fairmont San Jose in San Jose, California

Abstract
As CDISC guidelines nears becoming a regulation, it becomes apparent for the need of an effective method for documenting and communicating metadata to facilitate the review of clinical data during a submission. DEFINE.XML has proven in initial implementations and FDA pilot project to be an essential part in helping reviewers navigate data and related reports while also pointing out the needed improvements and challenges from implementing this in XML. This panel discussion will highlight real world examples of various approaches and shares lesson learned and innovative unique approaches. This includes technical techniques using SAS and processes and methodologies that spans any specific technologies.

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