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Landen Bain CDISC October 9, 2013

Brief Profile Proposal for 2012/13 presented to the Quality, Research & Public Health (QRPH) Planning Committee. Landen Bain CDISC October 9, 2013. The Problem.

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Landen Bain CDISC October 9, 2013

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  1. Brief Profile Proposal for 2012/13presented to theQuality, Research & Public Health (QRPH) Planning Committee Landen Bain CDISC October 9, 2013

  2. The Problem Since 2003, CDISC has worked with IHE’s QRPH and ITI domains to address the needs of clinical research as it is performed at healthcare sites. This effort has led to the development of a number of integration profiles: RFD at ITI, and QRPH’s CRD, DSC, Redaction, RPE, CRPC, RM, and DEX. This body of work has had mixed success in testing and implementation. RFD, CRD and DSC have had notable implementations, but the more advanced workflow approach has not had much uptake. And now DEX offers a fundamentally new approach to content specification that could supersede CRD and DSC. The value of implementing the entire body of QRPH research profiles remains a potential, not a realized benefit.

  3. Value Proposition This paper will address the need for better cohesion among the named research profiles, better implementation cases, and will identify gaps in the flow among the profiles. The paper will show how the complete set of QRPH profiles can create EHR-enabled research capabilities for all facets of study set up and execution. Three or more case studies will then show how sub-sets of the complete solution can be used in real world implementations. Case studies will be based on EHR4CR, Structured Data Capture, and an enterprise implementation.

  4. Market Readiness The point of this white paper is to increase the implementation readiness of an existing set of profiles.

  5. Existing IHE Profiles and Risks RFD, CRD, DSC, Redaction, RPE, CRPC, RM, DEX, SDC

  6. Use Case Current Use Case/Proposed Use Case The white paper will articulate a ‘super use case’ which links the use cases of the research related profiles.

  7. Proposed Standards & Systems HL7: C-CDA IHE: RFD, CRD, DSC, Redaction, RPE, CRPC, RM, DEX, SDC CDISC: SDTM, ODM, CDASH, SHARE, SDM, Protocol Representation ISO: 11179, 19763-13

  8. Discussion What level of effort do you foresee in developing this profile? Moderate. White Paper Editors: Landen Bain, CDISC Gokce Laleci, SRDC Christel Daniel, INSERM

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