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FW: [cri-wg] "Results and Lessons from the CDISC SDTM/ADaM Pilot Project" webinar -- 25 February 10am EST -- plus forum discussions!

From: Kashyap, Vipul <VKASHYAP1@PARTNERS.ORG>
Date: Sat, 23 Feb 2008 09:39:28 -0500
Message-ID: <DBA3C02EAD0DC14BBB667C345EE2D12401E2AEF2@PHSXMB20.partners.org>
To: <public-hcls-coi@w3.org>
Some of you may be interested in joining this conference.


From: cri-wg-bounces@mailman.amia.org [mailto:cri-wg-bounces@mailman.amia.org]
On Behalf Of Stan Kaufman
Sent: Friday, February 22, 2008 9:44 AM
To: cri-wg
Subject: Re: [cri-wg] "Results and Lessons from the CDISC SDTM/ADaM Pilot
Project" webinar -- 25 February 10am EST -- plus forum discussions!

Stan Kaufman wrote: 

	We've been working with CDISC on a series of webinars about key topics
in our domain. We apologize for the short lead time, but the first one will
happen this coming Monday. This will be great, so sign up ASAP and don't miss

I neglected to mention that we've set up a discussion area for this webinar at
our web site:


Register at the site and you'll be able to post questions and discuss the
webinar and its themes with the speakers!

	Results and Lessons from the CDISC SDTM/ADaM Pilot Project
	Date: 25 February 2008
	Time: 10:00 a.m. EST/3:00 p.m. London Standard Time
	Registration details: 
	Presented By: Cathy Barrows. Ph.D.; Chris Holland; Edward D. Helton,
Ph.D.; Rebecca Daniels Kush, Ph.D.

	The CDISC SDTM/ADaM Pilot Project was conducted as a collaborative pilot
project with FDA and Industry.  The objective of the pilot project was to test
how well the submission of CDISC-adherent datasets and associated metadata met
the needs and the expectations of both medical and statistical FDA reviewers.
In doing this, the project also assessed the data structure, resources and
processes needed to transform data from a data source into the SDTM and ADaM
formats, and to create the associated metadata.  An additional goal was to
produce a worked example implementation of the CDISC standards available at that
time, including the Define.xml file.

	This webcast will review the experiences, results, and learnings of the
pilot project core team regarding the creation of a CDISC-adherent submission.
Key aspects of the worked example will be highlighted, as will issues to keep in
mind while exploring the example package (e.g., improvements or changes made in
standards that are not addressed in the package).

	Perspectives on the pilot project will be presented from CDISC and from
the FDA, with a live question and answer session at the conclusion of the

	Learning Objectives:

	*	Gain an understanding of the logistics and processes used in the
CDISC SDTM/ADaM pilot project 
	*	Hear key points deemed worthy of emphasis: the successes, the
snags, and the solutions and work around that went into the successful
completion of this pilot 
	*	Learn from the pilot project experience what things to consider
when planning for your own CDISC submissions 
	*	Hear from FDA the positive effects of CDISC data standards on
the submission and review process. 

	About Cathy Barrows. Ph.D.; Chris Holland; Edward D. Helton, Ph.D.;
Rebecca Daniels Kush, Ph.D.

	Cathy Barrows, Ph.D., (speaker) is an Associate Director at
GlaxoSmithKline, where she has worked as a biostatistician for over 12 years.
She is responsible for managing a team of statisticians and statistical
programmers in Neurosciences Phase II/III Research and Development. At GSK, Dr.
Barrows also serves on the CDISC implementation team.

	Dr. Barrows has worked as a member of the CDISC ADaM team since 2004 and
was one of the co-leaders of the CDISC SDTM/ADaM Pilot Project.

	Chris Holland (speaker) has served as a statistical reviewer in the
FDA's Center for Drug Evaluation and Research for the past 2 years.  During this
time he has been an active participant in CDISC-related projects and
initiatives, including his role as the technical lead of the FDA review team for
the CDISC SDTM/ADaM pilot project.  Prior to joining the FDA he served as the
Director of Biostatistics and Clinical Data for Sucampo Pharmaceuticals, where
he was involved in creating CDISC-compliant data for regulatory submissions.

	Edward D. Helton, Ph.D., (moderator) is the Chief Pharmaceutical and
Regulatory Strategist at SAS. He is responsible for guidance and compliance of
SAS software in the pharmaceutical industry. Prior to joining SAS, Dr. Helton
was a Senior Clinical Study Director in the Neuroclinical Trial Center at the
Virginia Neurological Institute. As Vice President of Regulatory Affairs for
Quintiles Inc., he was responsible for global drug submissions, a position that
allowed him to build upon his already-extensive experience working with the FDA.

	Dr. Helton has continued his scientific research and been closely
involved in both the design and FDA submission of pharmacokinetic, efficacy and
safety data of recombinant drugs, synthetic peptides, endogenous products and
low molecular weight lipophilic xenobiotics.

	Rebecca Daniels Kush, Ph.D. (moderator) is a founder and the president
of the Clinical Data Interchange Standards Consortium (CDISC).

	Dr. Kush has over 25 years of experience in clinical research and
clinical trials. Her focus areas are standards for data interchange, process
redesign, strategy and metrics, particularly associated with the implementation
of new technologies to support electronic clinical trials.

	Her prior industry-related positions include the U.S. National
Institutes of Health; Eisai Co., Ltd. and Baxter-Travenol in Japan and Europe;
and Pharmaco, a global contract research organization.


	cri-wg maillist  -  cri-wg@mailman.amia.org

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Received on Saturday, 23 February 2008 14:39:45 UTC

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