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CMDR Plan of Action. Version 3 9 th October 2008. Note. This slide set is designed to facilitate discussion on the project logistics and not discuss technical content. . Background From BoD Meeting September 2008. Implications. Resource Money & People Process & Governance
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CMDR Plan of Action Version 3 9th October 2008
Note This slide set is designed to facilitate discussion on the project logistics and not discuss technical content.
Implications • Resource • Money & People • Process & Governance • For development of content • Collaborate with whom? • Technology • Content • Funding
Implications • Terminology • Who does CMDR work with LOINC, SNOMED etc. • Communication • Need to ensure CMDR is “sold” correctly
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)
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
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
Communications • How do we communicate the message about the CMDR effectively • Make consistent with all of our communications
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
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
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
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
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
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
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.
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
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
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
Deliverable • Report detailing • The business requirements • The suggested solution • Options • Partners • A pilot/prototype system demonstrating key features
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
Meetings • Individual Streams • TC every week or every two weeks • Overall • Possible face-to-face meetings • November • January