I currently own a contract research organization company in Westchester New
York. My company specializes in data processing services (database design, data
management, statistical programming, etc.) Currently, I am offering one free
service (database design in Access, data validation, or statistical programming
of four illustrations). If you are interested - please drop me a note. I am
capable of handling financial data as well.

Regards,
Amy Moore
President of Cross-Trained Data Professionals LLC

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

I will be out of the office starting  07/06/2007 and will not return until
07/16/2007.

1. Definition of Arms

Our study is a dose-escalating Phase 1 trial, should we use dose to define arm?  There are many scenarios of doses.  Do we have to list of all possible doses as proposed in the protocol or just those actually administered to patients in the study? In addition, a patient could have different doses during the study.  How do we code the arm for these patients, defining a unique arm with mixed dosing?  In addition, a patient could have various number of dosing/cycle (defined below).  How do we incorporate this into the arm?

2. Definition of Elements:

In our study, a patient will basically go through following stages: screening, dosing, end of treatment and follow-up.  In dosing stage, there are lots of scenarios, such as: transitioning to different doses, transitioning to extra rest periods due to AE, various number of repeated dosing.  What's the best way to define elements in this case?

3. Definition of Visits:

In our study, a treatment cycle is defined as an interval of two weeks with first 5 days being treated with the drug everyday, and the next 9 days to followup.  A patient could be examined in any study days for lab, VS, etc, and also a patient could have more than more cycles.  We propose using the cycle to code for VisitNum.  Is this sufficient even there are multiple days of examinations within a single cycle?  If so, is it required to code dy variable in the study datasets?

CDISC Interchange:  CDISC User Networks Gather to Develop 2006-2007 Agenda

CDISC users will gather to develop the CDISC User Network agenda for 2006-2007. Hosted by CDISC during the CDISC International Interchange, September 26, 27, and 28 in Bethesda, Maryland, users will meet in three distinct forums during the Interchange. Interested users are encouraged to contact Michael Palmer at mcpalmer@....

On Tuesday, September 26, users will participate in a lunchtime roundtable session. Moderated by Susan Kenny of Inspire Pharmaceuticals, recognized thought leaders in the area of CDISC implementation will lead round table discussions with the CDISC user community with the objective of prioritizing major CDISC implementation issues.

In the September 27 morning session of the CDISC Interchange plenum, Michael Palmer of Zurich Biostatistics, will lead a discussion by the thought leaders of their CDISC war stories.

Following that discussion, breakout groups will work towards a user-wide consensus on ranking the major CDISC implementation issues faced by the CDISC user community.

The third forum will take place on Thursday morning, September 28 with Dan Godoy of AstraZeneca chairing the session. Dan's task will be to interpret the rankings and discussions of Wednesday and lead the Thursday forum to the final consensus short list of CDISC implementation issues for the CDISC Users Networks to focus on in 2006-2007.

CDISC Users Networks are a grassroots movement of CDISC users organized in local groups. Active User Networks are functioning in the San Francisco Bay Area, New Jersey-New York-Pennsylvania, the Delaware Valley, Chicago, Washington, D.C, Research Triangle Park, and Seattle.  The Users Networks cooperate with the national CDISC office but have no formal association with it. All CDISC users are invited to participate.

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Hello--

A reminder that our next CDISC users network executive committee
teleconference will be on Wednesday, February 8 at 2-3 pm EST. To
call-in:


Dial-in Number:  1.888.346.3950 or 1.404.260.5380 for international
callers
Participant Entry Code:    992873#


Don't miss the photo of face-to-face #3 attendees at:
http://groups.yahoo.com/group/NJNYPA_CDISC_UN

Agenda topics so far:
1. Report on fourth face-to-face meeting at BMS on January 19 (see
our group picture at http://groups.yahoo.com/group/NJNYPA_CDISC_UN ),
2. Plans for national users network/CDISC conference at the CDISC
Interchange in the fall,
3. Planning for fifth face-to-face meeting to be held in March,
4. CDISC virtual learning project,
5. Users network-produced guides/examples of SDTM implementation for
selected therapeutic areas,
6. Other business.

Regards,
Michael

Michael Palmer
Zurich Biostatistics, Inc.
www.zbi.net

Hello all,

A conflicts come up for me with this call and I have to re-schedule it
for the following week. The new call details are:

The date and time for the teleconference to continue planning a
national conference of CDISC users networks to be held jointly with
CDISC will be on Monday, February 20 at 3-4 pm EST. To call-in:


Dial-in Number:  1.888.346.3950 or 1.404.260.5380 for international
callers
Participant Entry Code:    992873#

I am sorry for making this late change.

Regards,
Michael Palmer

Please take a minute to update your contact information in our members
database.

Thank you