1. 7th German CDISC
User Group Meeting
Basel, 11 March 2010

2. 7th German CDISC User Group Meeting
Herzlich willkommen in Basel!

3. 7th German CDISC User Group Meeting Some words about „Basler Fasnacht“
Biggest carnival in Switzerland with 18’000 active participants. The tradition goes back to roman age, current setting since more than 100 years
Starts on the Monday after Ash Wednesday at precisely 4:00 am with the so-called Morgestraich
The carnival lasts for exactly 72 hours and, therefore, ends on Thursday morning at 4:00 am
Basler Fasnacht is often referred to as die drey scheenschte Dääg (the three most beautiful days)
There are two parades taking place on Monday and Wednesday afternoon are called Cortège
The oldest formations are the Cliquen, who march through the old town playing the Piccolo (Pfyffer) and Basler drum (Tamboure). Other formations are called (non-Clique individuals and small groups) and Gugge (marching brass bands), which participants are referred to as Waggis
Schnitzelbank singers are bards singing satirical verses about current events in Basel or from around the world. The verses are sung in Basel German and the singers show Helge (illustrations) to the current verse, also distributed in flyers known as Zeedel

4. 7th German CDISC User Group Meeting Agenda - Morning
Time
Topic
Who
9:30
Registration
All
10:00
Welcome
D. Rehn
10:15
Electronic study archival
ODM-based study archival
Legal aspects
W. Kuchinke,
J. Aerts, S. Semler
11:15
CDISC Open Source and low-cost solutions
OpenClinica
SDTM-ETL
OpenCDISC
J. Aerts
12:00
Lunch and Get-Together

5. 7th German CDISC User Group Meeting Agenda - Afternoon
Time
Topic
Who
13:00
Define.xml workshop
General and technical requirements
Define.xml generation
Define.xml tools
Define.xml validation
Outlook (technical, ADaM requirements)
M. Kawohl with Define.xml workstream members
15:30
Afternoon Break
All
16:00
CDISC News
D. Rehn
16:15
CDISC User Group Discussion
Elections: Chair and Executive Committee
Work stream concept
Topics of interest
Next meeting / Meeting locations
Workstream Leaders, all
16:45
Closing remarks

6. Electronic Study Archival W. Kuchinke, J. Aerts, S. Semler
ODM-based study archival
Legal aspects

7. CDISC Open Source and low-cost solutions J. Aerts
OpenClinica
SDTM-ETL
OpenCDISC

8. 7th German CDISC User Group Meeting Agenda - Afternoon
Time
Topic
Who
13:00
Define.xml workshop
General and technical requirements
Define.xml generation
Define.xml tools
Define.xml validation
Outlook (technical, ADaM requirements)
M. Kawohl with Define.xml workstream members
15:30
Afternoon Break
All
16:00
CDISC News
D. Rehn
16:15
CDISC User Group Discussion
Elections: Chair and Executive Committee
Work stream concept
Topics of interest
Next meeting / Meeting locations
Workstream Leaders, all
16:45
Closing remarks

9. Define.xml Workshop M. Kawohl with define.xml workstream members
General and technical requirements
Define.xml generation
Define.xml tools
Define.xml validation
Outlook (technical, ADaM requirements)

10. CDISC News CDISC Implementation Survey
Protocol Representation Model v1.0
CDISC SHARE Pilot Report
CDISC Interchange Europe

11. CDISC News CDISC Implementation Survey
We have conducted a number of surveys over the years in order to understand how the CDISC standards are being adopted and implemented. Your assistance has been invaluable to us and has helped CDISC appreciate the needs of the many communities who now use the standards and those who are planning to use them. We are now asking you to complete a very quick and easy survey considering those same key topics that we have covered in the past. It should take you no longer than 20 minutes to complete. We would be grateful if you could send this survey onto as many relevant people in your organization as possible and thank you for giving up your valuable time to assist CDISC The survey closes on 16 March 2010 at midnight GMT.

12. CDISC News CDISC Models – PRM v1.0
Final version of Protocol Representation Model v1.0:
Used for planning and design of a research protocol
Focuses on study characteristics and the definition and association of activities within the protocols, including "arms" and "epochs" 
Defines the roles that participate in those activities
Includes protocol content including Study Design, Eligibility Criteria, and the requirements from the ClinicalTrials.gov and World Health Organization (WHO) registries.
Based on the BRIDG Release 3.0 Protocol Representation sub-domain 
Includes all classes in the BRIDG Protocol Representation sub-domain
Includes some classes from other BRIDG sub-domains, generally classes required for ClinicalTrials.gov and the WHO registries

13. CDISC News CDISC Models – CDISC SHARE
Pilot report for CDISC SHARE:
CDISC Shared Health and Research Electronic Library
CDISC SHARE is a global, accessible, electronic library, which through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare
In the first instance, CDISC SHARE will contain the existing CDISC standards, such as CDASH and SDTM, providing machine readable element (variables) within those standards. This will allow a range of applications used within organizations to automatically access those definitions
The pilot report summarizes the observations and findings of the CDISC Share Wiki pilot project and is organized into four sections: Method, Results, Answers to Primary Questions, Other Lessons Learned and Conclusions:

14. CDISC News CDISC Members Only Area

15. Upcoming events CDISC Interchange Europe
26-30 April 2010
Royal Lancaster Hotel
Hyde Park, London, UK
Conference April 2010
Training 26, 27 & 30 April 2010
Preliminary Program:
German CDISC User Group Meeting:
27 April 2010, 17:30-19:00, followed by small reception

16. CDISC User Group Discussion
Elections: Chair and Executive Committee
Work stream concept
Topics of interest
Next meeting / Meeting locations

17. German CDISC User Group Election of Chair and EC (UG Bylaws)
Article 4 – Committees:
Members for the Executive Committee will be elected by the German CDISC User Group participants in a general meeting and by a simple majority and will serve for a term of approximately 2 years. The Executive Committee shall consist of a minimum of 3 people
The Executive Committee will elect a Chair who will serve a term of approximately 2 years by a simple majority. Candidates for the Executive Committee Chair should have an active record of service in the User Group and should usually have served on the Executive Committee.
Article 6 – Voting:
All present at a Meeting shall have the right to one vote, except as otherwise specifically provided in the Bylaws.
Decisions will be made by simple majority of the participants present if unanimous consensus cannot be reached. There is, however, an exception for amendments to the Bylaws (see Article 8).

18. German CDISC User Group Election of Chair and Executive Committee
Proposal:
Chair:
Elke Sennewald, Kendle
Executive Committee:
Jozef Aerts, XML4Pharma GmbH
Kurt Hellstern, Hands-On GmbH
Monika Kawohl, Accovion GmbH
Sebastian Claudius Semler, TMF e.V.
TASK: Chair and Executive Committee to be elected by German CDISC User Group to serve a term until (and including) first user group meeting in 2012

19. German CDISC User Group Workstream concept
Decision by Executive Committee: Merge of define.xml and ADaM workstreams into eSubmission workstream, led by Monika Kawohl
Open discussion on workstream concept:
Format (F2F, TC)?
Meeting frequency?
Discussion format (trainings, best practices presentations, common implementation of specific topics, etc.)?
What works well, what did not work?
Other workstream requirements
Other modules to be included?
Discontinuation of existing workstreams?

20. German CDISC User Group Topics of interest
Feedback from UG members (through registration form):
Submission to FDA
Define.xml file
CDASH eCRF - > SDTM implementation experience

21. German CDISC User Group Next meetings: Dates and locations
27 April 2010 Royal Lancaster Hotel, Hyde Park, London, UK 17:30-19:00
16. September 2010 Parexel GmbH, Berlin (personal communication by Stefan Bordasch) 10:00-17:00
February/March 2011 Kendle, Munich, Germany 10:00-17:00

22. A last word from the current chair
A last word from the current chair... A big thank you for all your support!!

23. Bis zum nächsten Mal und… weitere Teilnehmer sind immer willkommen!
Herzlichen Dank!
Bis zum nächsten Mal und…
weitere Teilnehmer sind immer willkommen!
Kontakte:
Chair/Coordinator: Elke Sennewald
ODM Work stream: Jozef Aerts
SDTM Work stream: Kurt Hellstern
eSubmission Work stream: Monika Kawohl
Organization/Interfaces: Sebastian Semler