CMDR Plan of ActionVersion 3

9th 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– 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

PlanOverall

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

PlanStrategyStream

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

PlanRequirements Stream

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

PlanCommunications Stream

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

PlanTechnical Stream

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

PlanDeliverable

Deliverable

• Report detailing– The business requirements– The suggested solution– Options– Partners

• A pilot/prototype system demonstrating key features

PlanOrganization

Organization

Organization – Business Stream

PlanTime Line

Time Line

22 29 6 13 20 27 3 10 17 24 1 8 15 22 29 5 12 19 26 2 9

SEPTEMBERSEPTEMBER OCTOBEROCTOBER NOVEMBERNOVEMBER DECEMBERDECEMBER JANUARYJANUARY FEBRUARYFEBRUARY

20082008 20092009

Meetings

• Individual Streams– TC every week or every two weeks

• Overall– Possible face-to-face meetings• November• January