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CRD Profile: Standard Format and Method for Clinical Research Data Capture

The Clinical Research Data Capture (CRD) IHE Vendor's Workshop 2008 discusses the integration profile phases and the adoption of standard format and method for capturing and submitting forms in clinical research. The CRD profile enables form population from EHR mapped data and provides domain-specific form requirements. The use case includes Investigational New Drug Trials and EHR linked to pharma sponsor via EDC.

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CRD Profile: Standard Format and Method for Clinical Research Data Capture

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  1. Clinical Research Data Capture (CRD) IHE Vendor’s Workshop 2008 IHE Quality, Research, and Public Health (QRPH) Jason Colquitt Greenway Medical Technologies

  2. RFD Profile Phases Integration Profile Phase Define standard format for forms Define standard method for retrieving and submitting forms Content Profile Phase Provide domain-specific form requirements Enable form population from EHR mapped data

  3. CRD Profile What does CRD do/provide? CRD describes the content and format to be used within the Prepopulation Data transaction described within the RFD Integration Profile.

  4. Use Case • Investigational New Drug Trials • EHR linked to pharma sponsor via EDC • EHR makes accessible the basic data collection variables • EHR request an electronic case report form • Physician completes and returns the electronic case report form to the EDC system

  5. Actors and Transactions

  6. Process Flow

  7. CRD Actors/Options Form Filler: An actor for retrieving Forms PrepopData Options: CCD Option ODM/CDASH Option Form Manager: An actor for supplying Forms PrepopData Options: CCD Option ODM/CDASH Option

  8. Process Flow

  9. CCD Option

  10. ODM/CDASH Option CDASH - Clinical Data Acquisition Standards Harmonization (Draft) ODM - Operational Data Model Final Version 1.3

  11. Process Flow

  12. CRD Reference Implementation Clinical Research CCD to Standard CRF (ODM/CDASH) Crosswalk XSLT The adopted format for this transformation Additional Use Cases to drive different flavors of transformations Maintain source control and facilitate sharing and updating

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