Agenda - Organisation - CDISC Case Study

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German CDISC User Group
Kopenhagen, 22 April 2008
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Agenda
Time Topic Who
1700-1715 Welcome DR, JH
1715-1730 German CDISC User group characteristics DR
1730-1815 From SDTM to ADaM and beyond Practical experience and key learnings JH
1815-1845 Group discussion All
1845-1900 German CDISC User group organization DR, all
1900-2000 Joint reception with other User Groups All
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Participants
Name Company
Monika Kawohl Accovion GmbH
Dagmar Kottig-Roth Accovion GmbH
Arnold Edelbert Accovion GmbH
Pia Ebhart BAXTER BioScience
Nicole Baumgartner BAXTER BioScience
Ingeborg Cil Baxter Innovations GmbH
Susanne Pangritz Bayer Healthcare
Gisela Potts F. Hoffmann-La Roche Ltd.
Daniel Rehn F. Hoffmann-La Roche Ltd.
Kurt Hellstern Hands-on GmbH
Name Company
Markus Stoll IBM Global Business Services
Elke Sennewald Kendle
Sabine Kiederle Kendle
Sabine Laukamp Kendle
Johannes Hüsing KKS Heidelberg
Sebastian Claudius Semler TMF e.V.
Johannes Drepper TMF e.V.
Joel Hoffman Waban Software
Olga Steinle XClinical GmbH           
Claus Lindenau XClinical GmbH           
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German CDISC User Group Characteristics
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Participation in CDISC Teams
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CDISC Models Experts
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Areas of interest
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Presentations from Team Members at the CDISC
European Interchange
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CDISC News
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FDAs Draft PDUFA IV 5-Year IT Plan
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FDAs Draft PDUFA IV 5-Year IT Plan

• The foundation for the standardized clinical
  content is the Clinical Data Interchange
  Standards Consortium (CDISC) Study Data
  Tabulation Model (SDTM). The SDTM will also
  include nonclinical requirements based on the
  Standard for Exchange of Nonclinical Data (SEND)
  models that is being harmonized with the SDTM.
  The CDISC content will be sent to FDA as an XML
  message using the Health Level Seven (HL7)
  Reference Information Model (RIM) and harmonized
  with the Biomedical Research Integrated Domain
  Group (BRIDG) Model.
• SDTM version 3.1.1 submissions are accepted by
  FDA. A draft implementation guide for SDTM 3.1.2
  is currently under review by CDISC and FDA. FDA
  and CDISC are in the process of forming a
  communications team that will ensure SDTM meets
  FDAs scientific requirements.

Source Draft PDUFA IV Plan, December 2007, Page
23
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eSubmission of Clinical Content Today
SDTM
SAS V5 XPT
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eSubmission of Clinical Conent Tomorrow
Metadata
SDTM
Derived (ADaM)

SAP


?
In Development
HL7 V3 Message(s)
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A Possible Timeline
2010
2011
2012
2013
2014
2015
2016
2009
2008
2017
Review Two Years
Two Years ??
New Rule Available
Mandatory electronic Submission
CDISC HL7 Messages Available
Withdrawl of SAS XPT files
SDTM CONTENT
SAS XPT Mechanism
CDISC HL7 Production Message(s)
CDISC HL7 Development
Warning The dates presented on this slide are
based upon the authors knowledge as of January
31st 2008. They are not official CDISC or FDA
policy!
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CDISC Case Study
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CDISC Case Study
Protocol
Form Setup Config
Data Capture
Mapping
Analysis
Submission
Review
CDASH
Protocol
SDTM ADaM
ODM
LAB
XML
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CDISC Case Study

• From SDTM to ADaM and beyond Practical
  experience and key learnings
• Joel Hoffman, Waban Software

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Group Discussion
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Group Discussion

• More information
• European CDISC Interchange
• CDISC Website (Members only area)
• Pilot project report
• Pilot Project Submission Package
• Metadata Tools used in the Pilot Project

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German CDISC User Group Organization
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User Group 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
• 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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Current German CDISC User Group Portal
http//groups.yahoo.com/group/german_cdisc_ug/
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Future German CDISC User Group Portal
http//cdiscportal.digitalinfuzion.com/Global20Us
er20Networks/Europe/German20Language/default.asp
x/
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Contact Network

• German CDISC User Group Portal
• News / Announcements
• Shared documents
• Discussions
• Surveys
• Member lists with profiles
• German CDISC User Group Meetings
• Working Groups
• Case Studies and Best Practices
• CDISC News

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General Introduction into CDISC Models
Course Course SDTM Theory Application
  Prerequisites A basic understanding of relational database design is helpful but not required.
  Brief Description The SDTM (Study Data Tabulation Model) is a specification in the FDA eCTD (electronic Common Technical Document) Guidance as the model for submitting clinical and preclinical data to the FDA in support of marketing applications. This class consists of 1) a detailed review of SDTM concepts, SDTM domain models, and relationship tables, 2) a discussion of common implementation issues, and 3) exercises including CRF-annotations and creation of datasets that reinforce attendees' understanding of the SDTM and the SDTM Implementation Guide.
  Attendees Will Learn 1) The theory behind SDTM and the format of data that will be required for submission to the FDA. 2) Key SDTM concepts. 3) How to represent various types of collected data in the SDTM format.
  Audience Standards Managers, Data Managers, Statisticians, Programmers, and others involved in the creation or submission of data. This course is also intended for those within regulatory agencies who will use or process data in this format.

• CDISC Interchange
• CDISC Workshops
• CDISC training courses
• CDISC vLearning

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QA
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Closing remarks
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Next Meeting

• Early September 2008
• Basel
• CDISC News
• CDISC Case Study
• Group Discussion
• User Group Steering Team
• Working Groups

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• Herzlichen Dank!
• Bis zum nächsten Mal und
• weitere Teilnehmer sind immer willkommen!
• Kontakte
• Daniel Rehn (daniel.rehn_at_roche.com)
• Ann-Sofie Bergstrom (ann-sofie.bergstrom_at_swe.sas.c
  om)