Presentation on theme: "7th German CDISC User Group Meeting Basel, 11 March 2010."— Presentation transcript:
1 7th German CDISCUser Group MeetingBasel, 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 yearsStarts on the Monday after Ash Wednesday at precisely 4:00 am with the so-called MorgestraichThe carnival lasts for exactly 72 hours and, therefore, ends on Thursday morning at 4:00 amBasler 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 CortègeThe 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 WaggisSchnitzelbank 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 TimeTopicWho9:30RegistrationAll10:00WelcomeD. Rehn10:15Electronic study archivalODM-based study archivalLegal aspectsW. Kuchinke,J. Aerts, S. Semler11:15CDISC Open Source and low-cost solutionsOpenClinicaSDTM-ETLOpenCDISCJ. Aerts12:00Lunch and Get-Together
5 7th German CDISC User Group Meeting Agenda - Afternoon TimeTopicWho13:00Define.xml workshopGeneral and technical requirementsDefine.xml generationDefine.xml toolsDefine.xml validationOutlook (technical, ADaM requirements)M. Kawohl with Define.xml workstream members15:30Afternoon BreakAll16:00CDISC NewsD. Rehn16:15CDISC User Group DiscussionElections: Chair and Executive CommitteeWork stream conceptTopics of interestNext meeting / Meeting locationsWorkstream Leaders, all16:45Closing remarks
6 Electronic Study Archival W. Kuchinke, J. Aerts, S. Semler ODM-based study archivalLegal aspects
7 CDISC Open Source and low-cost solutions J. Aerts OpenClinicaSDTM-ETLOpenCDISC
8 7th German CDISC User Group Meeting Agenda - Afternoon TimeTopicWho13:00Define.xml workshopGeneral and technical requirementsDefine.xml generationDefine.xml toolsDefine.xml validationOutlook (technical, ADaM requirements)M. Kawohl with Define.xml workstream members15:30Afternoon BreakAll16:00CDISC NewsD. Rehn16:15CDISC User Group DiscussionElections: Chair and Executive CommitteeWork stream conceptTopics of interestNext meeting / Meeting locationsWorkstream Leaders, all16:45Closing remarks
9 Define.xml Workshop M. Kawohl with define.xml workstream members General and technical requirementsDefine.xml generationDefine.xml toolsDefine.xml validationOutlook (technical, ADaM requirements)
10 CDISC News CDISC Implementation Survey Protocol Representation Model v1.0CDISC SHARE Pilot ReportCDISC 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 protocolFocuses on study characteristics and the definition and association of activities within the protocols, including "arms" and "epochs" Defines the roles that participate in those activitiesIncludes 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-domainIncludes 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 LibraryCDISC 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 healthcareIn 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 definitionsThe 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:
15 Upcoming events CDISC Interchange Europe 26-30 April 2010Royal Lancaster HotelHyde Park, London, UKConference April 2010Training 26, 27 & 30 April 2010Preliminary 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 CommitteeWork stream conceptTopics of interestNext 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 peopleThe 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, KendleExecutive Committee:Jozef Aerts, XML4Pharma GmbHKurt Hellstern, Hands-On GmbHMonika Kawohl, Accovion GmbHSebastian 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 KawohlOpen 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 requirementsOther 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 FDADefine.xml fileCDASH eCRF - > SDTM implementation experience
21 German CDISC User Group Next meetings: Dates and locations 27 April 2010 Royal Lancaster Hotel, Hyde Park, London, UK 17:30-19:0016. September 2010 Parexel GmbH, Berlin (personal communication by Stefan Bordasch) 10:00-17:00February/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 SennewaldODM Work stream: Jozef AertsSDTM Work stream: Kurt HellsterneSubmission Work stream: Monika KawohlOrganization/Interfaces: Sebastian Semler