Berlin, September 25 th , 2007
description
Transcript of Berlin, September 25 th , 2007
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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ParticipantsInstitution 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 GroupTopics1. Identify need for CDISC Regional User Network
in regional area2. Notify CDISC (Shirley Williams)3. Create common location to share documents4. Notify Current Leader of the CDISC Global
User Network (Dan Godoy)5. Notify potential members6. Prepare for Initial Meeting(s)7. Elect/Form Executive Committee8. 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 ([email protected])– Ann-Sofie Bergstrom ([email protected])