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Strategic Action Plan for CMDR Development and Communication

This document outlines the strategic plan for the Clinical Metadata Repository (CMDR) as discussed in the Board of Directors (BoD) meeting in September 2008. It addresses implications related to resources, processes, governance, and collaboration with key stakeholders like LOINC and SNOMED. It presents four main streams: Strategy, Requirements, Communications, and Technical Plans. The goal is to develop a comprehensive proposal and facilitate informed decision-making regarding CMDR by February 2009, ensuring effective partnership, governance, and communication strategies.

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Strategic Action Plan for CMDR Development and Communication

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  1. CMDR Plan of Action Version 3 9th 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. PlanOverall

  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. PlanStrategyStream

  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. PlanRequirements 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. PlanCommunications 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. PlanTechnical 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. PlanDeliverable

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

  27. PlanOrganization

  28. Organization

  29. Organization – Business Stream

  30. PlanTime Line

  31. Time Line 2008 2009 SEPTEMBER OCTOBER NOVEMBER DECEMBER JANUARY FEBRUARY 22 29 6 13 20 27 3 10 17 24 1 8 15 22 29 5 12 19 26 2 9 Business Requirements Business View - Protocol Business View - Variable Governance Strategy Design SDTM Map Build and Populate Prototype Views Other Maps Data Integration Example TB or CV Terminology Link to Healthcare Communications Report

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

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