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Dear RTP CDISC Network,
In case you're curious what our sister group in the Bay Area is doing this month, please read on...
Happy New Year!
Susan
----- Forwarded by Susan P Duke/PharmRD/GSK on 04-Jan-2006 12:25 PM -----
| "John Brega"
<JBrega@...>
04-Jan-2006 04:58 |
|
Mark your calendar for the next meeting of the Bay Area CDISC Implementation Network, on Thursday, January 26th at 1:00. Patty Gerend has graciously volunteered the facilities at Genentech in South San Francisco.
The entire meeting will be devoted to a seminar on CDISC’s ODM standard taught by Dave Iberson-Hurst, CDISC’s principal ODM trainer. Dave is coming from the UK for the DIA/CDISC/FDA/ACRO meeting in Arlington, VA on January 25th, and at the suggestion of Becky Kush and Frank Newby of CDISC, he has agreed to take a side trip to the Bay Area to do this seminar. There is no charge for the event.
Why ODM is Important to You
The FDA intends to adopt XML in place of SAS V5 Transport files as the format for submitted data. The Operational Data Model (ODM) is CDISC’s XML-based standard for the interchange of clinical trial data. The ODM will therefore become important to anyone submitting SDTM data to the agency. CDISC will soon release for public comment, the specification for how use ODM to transport SDTM data.
Seminar Topics
Dave will present an overview of the ODM and some case studies on how it’s being deployed in the industry today. Seminar topics will include:
- What ODM is and the original design objectives behind the model
- How it is currently being used within industry
- How it will form the backbone of the overall package of CDISC standards
- How it will be used to transport submission data to the FDA
About Dave Iberson-Hurst
Dave founded Assero Ltd., which specializes in the use of the ODM standard and its deployment for eClinical trials. Dave is a Co-lead of CDISC’s electronic Source Data Interchange (eSDI) group and a member of the ODM team, as well as a member of two of CDISC’s key advisory and oversight committees. He is an official CDISC trainer for ODM and has also given seminars and presentations on ODM related-topics at conferences in Europe, the US, Japan and Australia.
As usual, I will send out an agenda and directions to the meeting in another couple of weeks.
John Brega
John Brega
Standards Implementation and Integrated Safety
PharmaStat LLC
Web: www.pharmastat.com
Email: JBrega@...
Phone: 510-482-2432
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