Transcript German CDISC User Group - Digital Infuzion, Inc.

German CDISC
User Group
Berlin, September 25th, 2007
Herzlich willkommen zum ersten
Treffen der deutschsprachigen
CDISC User Group!
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Participants
Institution
Bayer Schering Pharma AG
Bayer HealthCare AG
Bayer HealthCare AG
Bayer HealthCare AG
Biometrics Kendle
Biometrics Kendle
Biometrics Kendle
Biometrics Kendle
ClinResearch GmbH
Germany Chiltern
F. Hoffmann-La Roche AG
Geschäftsstelle TMF e.V.
Geschäftsstelle TMF e.V.
i3Statprobe
Insightful Corporation
Insightful AG
KKS Heidelberg
KKS Mainz
ZKS Essen
ZKS Essen
Nycomed GmbH, Dpt. Data Science
Nycomed GmbH, Dpt. Data Science
PAREXEL International GmbH
PAREXEL International GmbH
PAREXEL International GmbH
PAREXEL International GmbH
First Name
Andreas
Tanja
Dagmar
Otto
Sabine
Daniela
Angela
Elke
Christian
Miriam
Daniel
Johannes
Sebastian Claudius
Alexander
Joel
Martin
Johannes
Rolf
Michael
Anja
Berthold
Birgit
Dieter
Peter
Matthias
Petra
Family Name
Gromen
Petrowitsch
Segschneider
Schramek
Kiederle
Klupsch
Schlüter
Sennewald
Sachara
Neuhaus
Rehn
Drepper
Semler
Appelt
Hoffman
Studer
Hüsing
Meinert
Nonnemacher
Marr
Traub
Warning
Helwig
Knieling
Kruse
Rein
Institution
PAREXEL International GmbH
PAREXEL International GmbH
PAREXEL International GmbH
PAREXEL International GmbH
PAREXEL International GmbH
XML4Pharma
ZKS Freiburg
ZKS Freiburg
????
VHitG E.V.
Kompetenznetz Parkinson
Kompetenznetz Parkinson
iAS interActive Systems GmbH
iAS interActive Systems GmbH
KKS Leipzig
POSITIVE-Net
Metronomia Clinical Research GmbH
????
ZKS Köln
ORACLE Deutschland GmbH
KKS Marburg
BIOTRONIK GmbH & Co. KG
Baxter AG
Merz Pharmaceuticals GmbH
Sun Microsystems GmbH
First Name
Sarah
Alois
Paul
Claudia
Gerd
Jozef
Adrian
Margit
Hans-Peter
Andreas
Gisela
Jörg
Susanne
Ulrike
André
Corinna
Dieter
Christof
Gustav
Eva
Uwe
Thomas
Ingeborg
Tatjana
Heiko
Family Name
Kern
Reimer
Hellwig
Prange
Neuhaus
Aerts
Tassoni
Kaufmann
Marschall
Kassner
Antony
Liebner
Schneider
Jonas
Rothe
Engel
Meyer
Gessner
Vella
Sellge
Kruschinski
Zink
Cil
Elenschläger
Lemke
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Agenda
10:30
Welcome
10:30
e3C welcome note
Tim Jaeger
10:40
Welcome address
Ann-Sofie Bergstrom, Daniel Rehn
10:50
Short presentation of TMF, host of the 1st German User Group
meeting, and its community working groups
Sebastian Semler
11:05
CDISC Case Study
11:05
Presentation of the TMF ODM to SDTM Converter
11:50
CDISC News
11:50
Roadmap Outline: Further development and convergence of SDTM,
ODM & Co
12:30
Lunch and Get-Together
13:30
CDISC User Group Discussions / Q&A
13:30
Presentation of the CDISC User Group Starter Kit
Daniel Rehn
14:00
Discussion about the future topics, actions and time schedules of the
german-speaking CDISC user group
Daniel Rehn (Moderator), all
15:00
Q&A
All
15:25
Closing remarks
Daniel Rehn
Johannes Hüsing, Rolf Meinert,
Johannes Drepper
Jozef Aerts
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Presentation of the CDISC
User Group Starter Kit
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CDISC User Group Starter Kit
Existing contents:
• First User Group meeting presentation template
• Bylaws document / Charter
– Need working group to complete
• Step-by-Step Guidance Document
– How to proceed to initiate a user group
To come:
• CGUN portal access
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Description of Network(s)
• Background
– History of User Networks
– CDISC Support
– User Community Support
• Current status
• Organization
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History of User Networks
• CDISC User Networks started
appearing in the US around
2005
• US Networks felt the need to
have some common strategy
going forward
• US Networks decided
– To hear what Users wanted
the Networks to be
– To define an Action Plan for
the User Networks
• Detected three major themes
from Users
– Communication
– Education
– Organization
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Objectives
• Support CDISC
– Test models
– Propose implementation
approaches
– Propose new domains
– Provide a network to
address domain specific
issues
– Promote/distribute
standards
– Support CDISC activities
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Objectives (cont.)
• Support User
Community
– Provide more direct links to
CDISC Organization
– Contact Network
– Discussion Forum
– Expansion of community
(i.e., other Networks)
– More involvement
– Support for implementation
• Documentation of
issues/resolutions
• Access to documentation
(regardless of
implementation level at
individual company)
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Organization
• Membership
– Open to anyone (CRO, Bio-Pharma, others)
– Regionally oriented for meetings, nation/world-wide for communications
• Organization
– Coordinator(s) [moderator, minute takers]
– Meeting Committee [agenda, materials]
– Other(s)?
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Organization
• ByLaws / Charter
– Template prepared CGUN Education Committee
– Need working group to complete
• Other Documents
–
–
–
–
–
Membership List
CDISC Specialists List
Key Area of Interests List
Minutes/Logs
Presentations
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Current Status
US User Groups
European User Groups
Chicago
English CDISC
User Group
Seattle
Nordic CDISC
User Group
Boston Area
Washington, D.C. Area
Atlantic (NY, NJ, PA)
Bay Area
Research Triangle Park
German CDISC
User Group
Delaware Area
French CDISC
User Group
Italian CDISC
User Group
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Steps to initiate a User Group
Topics
1. Identify need for CDISC Regional User Network
in regional area
2. Notify CDISC (Shirley Williams)
3. Create common location to share documents
4. Notify Current Leader of the CDISC Global
User Network (Dan Godoy)
5. Notify potential members
6. Prepare for Initial Meeting(s)
7. Elect/Form Executive Committee
8. Author/complete bylaws
Status






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German CDISC User Group Portal
http://groups.yahoo.com/group/german_cdisc_ug/
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Discussion about the future
topics, actions and time
schedules of the german
CDISC User Group
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Structure: F2F Meetings
• Frequency
– Once per [interval]
• Format
–
–
–
–
–
Duration = [duration]
Welcome [duration]
CDISC Case Study
CDISC News
CDISC User Group Discussions
• Workstream presentations [duration]
• Q&A
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Structure: Teleconferences
• Frequency
– Once per [interval]
• Format
– Duration = [duration]
– Introduction/Roll call [duration]
– CDISC News
– Workstream(s) presentations [duration]
– Q&A
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Structure: Content
• Key areas of interest
• Workstream(s)
• Content structure
– Topics to be submitted [time period] prior to
meeting
– Workstreams discussions/progress
• Maximum of [n] per meeting
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Next Steps
•
•
•
•
•
•
•
Sign up for membership list
today
Sign up for Workstreams
today
Sign up for Expert list
today
Collect key areas of interest
today
Suggest topics for next meeting(s)
today
Complete Bylaws document
asap
Approve Bylaws document
next meeting
• Date for next TC
• Date for next F2F Meeting
today
today
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Q&A
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Closing remarks
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Closing remarks
Herzlichen Dank!
Bis zum nächsten Mal und…
weitere Teilnehmer sind immer
willkommen!
• Kontakte:
– Daniel Rehn ([email protected])
– Ann-Sofie Bergstrom ([email protected])
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