To the Atlantic CDISC USER GROUP and Friends,

Sorry for the late notice, but mark your calendar for a meeting on
Wednesday, August 8 from 9:00 to 12:30 -- note that this is a
morning meeting! Thanks to Gina Wood (georgina.wood@...)
of Novartis for suggesting this event and making all the
arrangements, and for volunteering Novartis's facilities in East
Hanover, NJ.

If you are planning on attending, please RSVP to CarolAnn DeStefano
(carolann.destefano@...) & Janice Wrosek
(janice.wrosek@...) by close of business Monday August 6,
2007, providing your name and company affiliation. Please also note
that you should arrive between 8.15 and 8.30 on the 8th August to go
through security.

The entire meeting will be devoted to an overview of CDISC's SDTM
Implementation Guide for Human Clinical Trials (SDTMIG) Draft
Version 3.1.2 being published now. The overview will be given by
Tom Guinter, VP of Clinical Information Services at TAKE Solutions
and CDISC SDS Team member, and may have additional presenters from
the SDS team who are still confirming their attendance.

Background

The CDISC SDS team published Draft Version 3.1.2 of the SDTM
Implementation Guide for industry comment last week. Version 3.1.2
has many changes, enhancements and corrections, and is now 299
pages, up from 183 pages for v3.1.1. The comment period is 60 days,
a short time considering the size of the document, the number of
changes and the significance to industry.

Note that CDISC is also announcing a series of free webinars on the
proposed changes in this release, and this presentation is
coordinated with those webinars. The webinars will be 60-90
minutes, while we have 3.5 hours dedicated to this presentation at
the user network, allowing a more detailed review in many specific
areas.


The Presentation

The purpose of this session is to provide an update on all aspects
of v3.1.2. It will be presented in three sections:

1. An overview of the SDTMIG v3.1.2 comment, review and
finalization process, and expectations for sponsor review. This
will include information on what is open for comment, and what
really is not.

2. An overview of the changes incorporated in v3.1.2: what is
a new feature, what is a change, what is a clarification, and what
is just editorial. This will be a detailed discussion, helping to
identify the changes going from SDTMIG v3.1.1 at 183 pages to SDTMIG
v3.1.2 at 300 (+/-) pages. Changes will be identified by their
significance, from not-backwards-compatible to minor.

3. A detailed review of the significant changes and new
features.

The goal is to provide a clear understanding of what the SDTMIG
v3.1.2 is so you can:

1. Comment on the release during the review/comment period.
Hopefully it will give you a head start on reviewing the SDTMIG
v3.1.2, allowing you to focus your review on the sections and issues
that are most important to you and your company.

2. Begin to capitalize on the clarifications and enhancements
immediately. There are numerous clarifications and enhancements
that can be implemented already without violating the SDTM v1.1 /
SDTMIG v3.1.1. In-fact many of these enhancements and
clarifications provide important answers and direction where none
was previously available.

About Tom Guinter

Tom is VP of Clinical Information Systems for TAKE Solutions. His
group focuses on the implementation of clinical data standards for
sponsor process enhancement and preparation of compliant clinical
data. Tom is a principal contributor to the CDISC SDTM, a member of
the SDTM Standards Review Committee, and a Submission Data Standards
team member since 2001. He was an official CDISC trainer for the
SDTM from 2005 - 2006.




Regards

Jules