Stuttgart, 22 September 2009

6th German CDISCUser Group Meeting

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6th German CDISC User Group Meeting

Herzlich willkommen in Stuttgart (statt Ehningen)!

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6th German CDISC User Group MeetingAgenda - Morning

Time Topic Who

09:30 Registration All

10:00 Welcome D. Rehn, P. Leister

10:15 CDISC User Group Work Streams ODM SDTM ADaM Define.xml

Work Stream Leaders, All

12:30 Lunch and Get-Together All

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6th German CDISC User Group MeetingAgenda - Afternoon

Time Topic Who

13:15 CDISC Case Studies SDTM 1.2/SDTM IG 3.1.2 tutorial – 60 min LOINC tutorial – 60 min

SDTM workstreamS. Semler, J. Aerts, K. Hellstern

15:15 Afternoon Break All

15:30 CDISC User Group Organization & CDISC News CDISC European Interchange and public training

format discussions Upcoming CDISC meetings and trainings

D. Rehn

16:00 CDISC User Group Discussion Work stream summaries Topics of interest Next meeting / Meeting locations Q&A

All

16:30 Closing remarks D. Rehn

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CDISC User Group Work Streams

• ODM – J. Aerts, XML4Pharma

• SDTM – K. Hellstern, Hands-On GmbH

• ADaM – E. Sennewald, Kendle

• Define.xml – M. Kawohl, Accovion GmbH

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6th German CDISC User Group MeetingAgenda - Afternoon

Time Topic Who

13:15 CDISC Case Studies SDTM 1.2/SDTM IG 3.1.2 tutorial – 60 min LOINC tutorial – 60 min

SDTM workstreamS. Semler, J. Aerts, K. Hellstern

15:15 Afternoon Break All

15:30 CDISC User Group Organization & CDISC News CDISC European Interchange and public training

format discussions Upcoming CDISC meetings and trainings

D. Rehn

16:00 CDISC User Group Discussion Work stream summaries Topics of interest Next meeting / Meeting locations Q&A

All

16:30 Closing remarks D. Rehn

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CDISC Case Studies

• SDTM 1.2/SDTM IG 3.1.2 tutorial – SDTM Workstream Members

• LOINC tutorial – S. Semler, J. Aerts, K. Hellstern

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CDISC News

• CDISC European Interchange meeting and workshop format discussions

• CDISC SHARE

• Upcoming CDISC meetings and trainings

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CDISC Interchange Europe - MeetingMeeting format discussions (1)

Aim:• To radically re-structure a large piece of the meeting to allow USERS ‘to be heard’

and to generate really rich feedback • To enable further development of the models, implementation guides and process so

that CDISC can continue to optimize deliverables moving forward with the true users in mind

• Send out a mail-shot to the users of CDISC standards in Europe, with the following questions:

– In your opinion are you more/less efficient / is the business more efficient now compared to ‘before CDISC’? - Elaborate

– What currently is causing you difficulties in the implementation of the more mature operational CDISC Models (E.g. SDTM, CDASH, ODM)

– What is causing you angst with the less mature, or more visionary, strategic models (PRG, BRIDG, Repository of Shared Semantics/CDISC SHARE)

– How easy is it to integrate the CDISC models into your company processes, considering your sourcing strategy and company set-up and infrastructure

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CDISC Interchange Europe - MeetingMeeting format discussions (2)

Process (cont.):• Ask users in this communication to hold Cross-functional meetings and discussion

within their companies to talk through these areas • Ask representatives from these groups or companies come to the 2010 Interchange,

prepared to talk through these issues. • Set up ‘Model booths’ – SDTM, ADaM, CDASH etc,

– Each booth would be chaired by a CDISC team lead / expert – with 3 or 4 helpers (also Subject Matter Experts) –

– We don’t want the experts/leads to share, talk or interject – but to LISTEN

– Each booth would be open 3 times in an afternoon session (3, one hour slots) and they’d be capped at say 40 people per session (4 tables of 10 in each booth).

• Issue the chairs with a ‘data capture tool’ that collects comments by table which is then ‘mergable’, and these data are then consolidated into a master set for analysis.

• The results ultimately will go to the CDISC team leads and CDISC BOD.

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CDISC Interchange Europe - WorkshopsWorkshop/training course format discussions

• New type of workshop/training course, dedicated to experienced users of the models • There are now a large number of experienced users of the CDISC standards, for

whom no consistent and truly global platform to share their experience with the CDISC teams is offered

• Set up the advanced user focused workshops in the surrounding days, the European Interchange will become more attractive for them.

– Host ½ or full day workshops on the most used models. – No long training sessions by the usual instructors– A number of presentations on advanced topics or problems within the models provided by

users of the models, interrupted by plenty of discussion in the room. – Participation of at least 1 key member from the relevant team, in order for them to listen to

discussions and suggestions and bring the feedback back into the model teams

• Questions arising from this concept:– Possible advanced topics or problems– Feedback on proposed format– General ideas/suggestions

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CDISC SHAREFormally known as CMDR or CRSS - Introduction

• Some sporadic, limited efforts at creating industry standard concepts and variables e.g. the joint NIH/CDISC tuberculosis standard

• Individual organizations (Pharma, CROs, institutions etc) typically use internal standards (i.e. standards developed within individual organizations)

• Many intend to move to the use of SDTM and ADaM, but they do not provide a complete set of concepts and variables even for clinical research

• As a consequence, the ability to aggregate data and to share data is limited as data have to be mapped to alternative standards

CDISC SHARE – CDISC Shared Health and Research Electronic Library; CMDR – CDISC Meta Data Repository; CRSS – CDISC Repository of Shared Semantics

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CDISC SHAREGoal and status

Goal:• Provide ready access to standards for clinical research and related areas of

healthcare via a global, accessible electronic library called SHARE• Enable access to precise and standardized data element definitions that can

be used in applications and studies to improve data quality and interoperability for biomedical research and its link with healthcare

Status:• CDISC is presently completing the ‘Inception Phase’ of this project, which

entails– Conducting a pilot (Mayo Clinic, GSK, MD Anderson, Eli Lilly and Genzyme) with

50 data elements (variables) in the oncology therapeutic area– Developing a Scope and Vision document that includes risks, benefits and a

stakeholder analysis among other sections– The SHARE pilot uses a semantic wiki hosted by Mayo Clinic and the National

Cancer Institute

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CDISC SHAREWebcast

• CDISC SHARE: Exploring the Collaborative Development of a Global, Shared Electronic Library

• Date: 6 October 2009

• Time:Berlin  14:30 – 16:00 CET

• Duration:The presentation will last 45 minutes and will be followed by a 15 minute Q&A session

• Registration: http://www.bettermanagement.com/seminars/seminar.aspx?l=15140

This webinar will include:• An introduction, including comments

on how SHARE can benefit clinical research, by CDISC Board Chair, Edward Helton, PhD, of the National Cancer Institute

• An overview of SHARE and early results of the Pilot by CDISC VP, Technical Strategy, Dave Iberson-Hurst

• Stakeholder Analysis summary by CDISC CEO, Rebecca Kush, PhD

• Potential business models and the next steps for SHARE by CDISC COO, Frank Newby

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Upcoming eventsCDISC Public Training Course

CDISC Public Training Course Belgium28 September – 1 October 2009

Business and Decision Life SciencesSint Lambertusstraat 1411200 Brussels

ODM implementation (Philippe Verplancke)SDTM Theory & Application (Peter van Reusel)ADaM Theory & Application (Susan Kenny)

Registration:http://guest.cvent.com/EVENTS/Info/Summary.aspx?e=2854e199-aab5-4c59-

b92a-4163e7a0219a

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Upcoming eventsCDISC Interchange North America

CDISC Interchange North America

9-13 November 2009

Marriott Baltimore Waterfront Hotel

700 Aliceanna Street

Baltimore, MD 21202

Preliminary Program

Conference 11-12 November 2009

Training 9, 10 & 13 November 2009

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Upcoming eventsCDISC Interchange Europe

CDISC Interchange Europe

26-30 April 2010

Royal Lancaster Hotel

Hyde Park, London, UK

Conference 28-29 April 2010

Training 26, 27 & 30 April 2010

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CDISC User Group Organization

• German CDISC User Group Portal

• Work streams–Summary of today‘s discussion–Setup and going forward

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German CDISC User Group PortalOverview and topics for today

http://cdiscportal.digitalinfuzion.com/Global%20User%20Networks/Europe/German%20Language/default.aspx/

Topics:• Overview• Sign in• Change password• Alerts• Surveys• Discussions

• Feedback, room for improvements

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CDISC User Group Work Streams Summary of today‘s discussions

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CDISC User Group Work Streams Goals

Goals:• Sharing of expertise and knowledge• Identification of implementation examples• Identification of implementation issues• New requirements – feedback to CDISC teams

Format:• F2F• Monthly TCs

Requirements:• Active participation• Willingness to contribute

• Feedback, going forward

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CDISC User Group Discussion

• Work stream summaries

• Topics of interest

• Next meetings / Meeting locations– Week of 15 February 2010, ???– 27 April 2010, London

• Q&A

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Herzlichen Dank!

Bis zum nächsten Mal und…

weitere Teilnehmer sind immer willkommen!

Kontakte:

• Chair/Coordinator: Daniel Rehn (daniel.rehn@roche.com)

• ODM Work stream: Jozef Aerts (jozef.aerts@xml4pharma.com)

• SDTM Work stream: Kurt Hellstern (kurt.hellstern@hands-on.ch)

• ADaM Work stream: Elke Sennewald (sennewald.elke@kendle.com)

• Define.xml Work stream: Monika Kawohl (monika.kawohl@accovion.com)

• Organization/Interfaces: Sebastian Semler (sebastian.semler@tmf-ev.de)