RTP CDISC User's Network Meeting Notice

We are thrilled to have Tom Guinter, VP of Clinical Information
Services at TAKE Solutions to come give us the lowdown and overview
of the new CDISC SDTM Implementation Guide draft version 3.1.2.
There is no charge for this talk and no RSVP is required.

Time: Thursday August 9th, 2007 from 1pm-4:30pm

Location: Duke Clinical Research Institute (DCRI)
DCRI headquarters directions found at
http://www.dcri.duke.edu/who_we_are/map.jsp
Go to the lecture hall in the basement floor of the DCRI North
Pavilion.


Background
The CDISC SDS team is days away from publishing Draft Version 3.1.2
of the SDTM Implementation Guide for industry comment. Version 3.1.2
will have many changes, enhancements and corrections, and is now 300+
pages, up from 183 pages for v3.1.1. The comment period will be 60
days, a short time considering the size of the document, the number
of changes and the significance to industry.
Note that CDISC will soon announce a series of free webinars on the
proposed changes in this release, and that this presentation is not
an official CDISC event. That said, Tom is superbly qualified to
speak on this topic as he is a key player on the SDTM team.

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.