1. CMDR Plan of Action Version 3 9 th October 2008

2. Note This slide set is designed to facilitate discussion on the project logistics and not discuss technical content.

3. Background From BoD Meeting September 2008

4. Implications Resource – Money & People Process & Governance – For development of content Collaborate with whom? – Technology – Content – Funding

5. Implications Terminology – Who does CMDR work with LOINC, SNOMED etc. Communication – Need to ensure CMDR is “sold” correctly

6. Outline Four streams – CDISC Operations to examine solution in detail – User Community to look at requirements and governance – CDISC Operations look at communications plan – Criteria for partnership for building and maintaining the solution – Strategy Committee (added during the BoD Meeting after discussion – not part of the original presentation)

7. Detailed Solution Develop examples using SDTM – Also look at other standards Demonstrate views of the data Answer the various technical questions raised Does this allow for the link to healthcare Look at impact on CDISC teams and their working Does this work for all stakeholders

8. Business Requirements & Governance Further develop the business requirements – Develop the various views and determine priority – Does this fulfil all of our needs Examine governance and process – How would we go about filling CMDR with content – How do we merge “existing” pharma content

9. Communications How do we communicate the message about the CMDR effectively Make consistent with all of our communications

10. Resulting In BoD Meeting in February 2009 we should have in place – Clearly defined need/requirements – Viable solution and demonstration – Governance and process models – Partners and collaborators – Clear communication plan – Plan for going forward

11. Plan Overall

12. Plan Purpose of this work is to provide a detailed proposal/report to the CDISC BoD in February 2009 so as to allow for an informed decision regarding the CMDR to be made. This is a feasibility study being performed on behalf of the CDISC Technical Advisory Committee. There will be 4 Streams to the work: – Strategy – Requirements – Communications – Technical

13. Plan Strategy Stream

14. Deliverables Scope the way in which CDISC wants to work with partners / organizations on CMDR – Who to work with? E.g. Hosting, content, governance, maintenance, others? W3C, NIH, WHO, ISO, HL7, NCI, WikiHIT, etc. – How to work with? – Funding? – Where/how does CDISC wish to position itself with regard to the CMDR? What role should CDISC play? – How do we communicate with these organisations? – This is strategic governance, the business model CDISC wishes to engage in

15. Plan Requirements Stream

16. Deliverables Requirements – Confirm the high-level requirements, what are the business issues the CMDR needs to address? Business Views – Definition of views needed, what does the content look like. Variable Protocol/Concept Governance – How to populate, add, control content – How to take pharma companies existing content, merge and populate the CMDR – This is tactical governance, how CDISC wishes to use the CMDR

17. Plan Communications Stream

18. Deliverables Communication Messages – Key messages about the project Benefits What it is What it is not – We must not scare people This is not another change SDTM and other standards stay stable This is all part of the continuing evolution & improvement of the CDISC standards

19. Plan Technical Stream

20. Deliverables Design Materials – Items required to build the solution in the future The technical solution (the logical design of the content) The business solution (its use to meet the need) Demonstration Materials – Items required to explain the solution – Items required to convince people that it is the right solution Process Materials – The impact on the CDISC process

21. Design Materials (1) Detailed design of repository (paper) – Describing both the design from a content and a technology perspective. Map of SDTM (portion) to CMDR Map of other standards to CMDR – TDM “Terminology” and how it fits with CMDR – MEDDRA, LOINC, SNOMED, CDISC etc.

22. Design Materials (2) The required “views” – From the business views within the requirements stream Link to healthcare – How does CMDR allow for the link to healthcare? – Give healthcare the clinical research “target” metadata All resulting in a specification of what to build

23. Demonstration Materials Populate electronic pilot of CMDR with SDTM (portion) Export of 1 or 2 “views” from CMDR Data integration – One or more examples of integration where diverse datasets are mapped/combined Input of TB domain mapped to CMDR

24. Process Materials Impact on standards development – How does this affect the current teams within CDISC? – What do we stop doing? – Linked to governance work TB or CV domain mapped to CMDR – Will help with process and governance

25. Plan Deliverable

26. Deliverable Report detailing – The business requirements – The suggested solution – Options – Partners A pilot/prototype system demonstrating key features

27. Plan Organization

28. Organization CDISC BoD CMDR Project DIH Technical Stream DIH Business Stream Bron Kisler Business Requirements Bron Kisler Variable View Steve Ruberg Protocol View Isabelle deZegher Governance Bron Kisler Comms Stream Amanda de Montjoie Strategy Stream Strategy Committee

29. Organization – Business Stream Business Stream Bron Kisler Business Requirements Bron Kisler Tom Grundstrom, Sue Dubman, Steve Ruberg, Isabelle deZegher, P-Y Lastic, Others TBD Variable View Steve Ruberg Existing Team, Others TBD Protocol View Isabelle deZegher Simon Bishop, Diane Wold, Lisa Chatterjee, Ed Seguine, Others TBD Governance Bron Kisler Chris Chute, P-Y Lastic, Simon Bishop, Steve Ruberg, Tom Grundstrom, Others TBD

30. Plan Time Line

31. Time Line 22296132027310172418152229512192629 SEPTEMBER OCTOBER NOVEMBER DECEMBER JANUARY FEBRUARY Design SDTM Map Terminology Link to Healthcare Build and Populate Prototype Views Report Other Maps Data Integration Example TB or CV 2008 2009 Business Requirements Business View - Variable Communications Governance Strategy Business View - Protocol

32. Meetings Individual Streams – TC every week or every two weeks Overall – Possible face-to-face meetings November January