1. © CDISC 2012 CDISC, IHE, DEX and other TLAs Landen Bain ISO/IEC JTC1/SC32/WG2 N1878

2. © CDISC 2012 Data Element Exchange (DEX) An IHE Profile EHRs contains data elements that can be used to populate parts of research case report forms DEX leverages the power of CDISC’s SHARE Metadata Registry and CDASH data element standard to apply mappings to eCRFs at the point of form design DEX will create a customized map of the elements in a particular case report form to the corresponding elements in the EHR export. The metadata registry maintains the exact interactions between the research and healthcare data elements, and will provide an exact map by which data can be extracted from the pre-population data set 2

3. Data Element Exchange (DEX) RetrieveDataElementList [QRPH -43]  Metadata ConsumerMetadata Source RetrieveMetadata [QRPH -44]  DEX Actor Transaction Diagram DEX maps research data elements to healthcare data elements 3

4. © CDISC 2012 CDASH eCRF Clinical Research Document (CRD) Pre-population of a Case Report Form 4 EHR CCD CRD XSLT Sponsor Healthcare Site EDC

5. 5 Healthcare EHR CCD 3. Data as CCD eCRF Research SHARE 2. Form as ODM EDC Extraction Specification 1. Build form from CDASH elements in SHARE Data Element Exchange Pre-population of a Case Report Form

6. © CDISC 2012 North American Connectathon New Directions for SDC Three vendors will be testing the new SDC profile and its attendant profiles RFD and DEX.  SRDC will enact the DEX Metadata Source actor.  Oz Systems will enact DEX Metadata Consumer and RFD Forms Processor.  Discussions are underway with an unnamed EHR to play the RFD Form Filler.

7. Metadata Source Metadata Consumer Form Processer Form Filler EHR Oz Systems SRDC DEX RFD SDC IHE Connectathon New Directions: Structured Data Capture