Berlin, September 25th, 2007

German CDISCUser Group

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Herzlich willkommen zum ersten Treffen der deutschsprachigen

CDISC User Group!

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Participants

Institution First Name Family NamePAREXEL International GmbH Sarah KernPAREXEL International GmbH Alois ReimerPAREXEL International GmbH Paul HellwigPAREXEL International GmbH Claudia PrangePAREXEL International GmbH Gerd NeuhausXML4Pharma Jozef AertsZKS Freiburg Adrian TassoniZKS Freiburg Margit Kaufmann???? Hans-Peter MarschallVHitG E.V. Andreas KassnerKompetenznetz Parkinson Gisela AntonyKompetenznetz Parkinson Jörg LiebneriAS interActive Systems GmbH Susanne SchneideriAS interActive Systems GmbH Ulrike JonasKKS Leipzig André RothePOSITIVE-Net Corinna EngelMetronomia Clinical Research GmbH Dieter Meyer???? Christof GessnerZKS Köln Gustav VellaORACLE Deutschland GmbH Eva SellgeKKS Marburg Uwe KruschinskiBIOTRONIK GmbH & Co. KG Thomas ZinkBaxter AG Ingeborg CilMerz Pharmaceuticals GmbH Tatjana ElenschlägerSun Microsystems GmbH Heiko Lemke

Institution First Name Family NameBayer Schering Pharma AG Andreas GromenBayer HealthCare AG Tanja PetrowitschBayer HealthCare AG Dagmar SegschneiderBayer HealthCare AG Otto SchramekBiometrics Kendle Sabine KiederleBiometrics Kendle Daniela KlupschBiometrics Kendle Angela SchlüterBiometrics Kendle Elke SennewaldClinResearch GmbH Christian SacharaGermany Chiltern Miriam NeuhausF. Hoffmann-La Roche AG Daniel RehnGeschäftsstelle TMF e.V. Johannes DrepperGeschäftsstelle TMF e.V. Sebastian Claudius Semleri3Statprobe Alexander AppeltInsightful Corporation Joel HoffmanInsightful AG Martin StuderKKS Heidelberg Johannes HüsingKKS Mainz Rolf MeinertZKS Essen Michael NonnemacherZKS Essen Anja MarrNycomed GmbH, Dpt. Data Science Berthold TraubNycomed GmbH, Dpt. Data Science Birgit WarningPAREXEL International GmbH Dieter HelwigPAREXEL International GmbH Peter KnielingPAREXEL International GmbH Matthias KrusePAREXEL International GmbH Petra Rein

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Agenda10:30 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 Johannes Hüsing, Rolf Meinert, Johannes Drepper

11:50 CDISC News

11:50 Roadmap Outline: Further development and convergence of SDTM, ODM & Co

Jozef Aerts

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

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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

Bay Area

Seattle

German CDISC User Group

Boston Area

Atlantic (NY, NJ, PA)

Chicago

Washington, D.C. Area

Research Triangle Park

Italian CDISC User Group

English CDISC User Group Nordic CDISC

User Group

French CDISC User Group

Delaware Area

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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 today• Date for next F2F Meeting 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 (daniel.rehn@roche.com)

– Ann-Sofie Bergstrom (ann-sofie.bergstrom@swe.sas.com)