EHR Enabled Research

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Project Overview

The goal of the keyCRF project is the creation of a semantically annotated electronic Case Report Form (eCRF) that can enable the pre-population of the eCRF from linked data elements in an EHR summary document, HL7's Continuity of Care Document (CCD). The project will draw on prior work of the Semantic Technology Work Group, specifically the RDF representation of the CDISC CDASH standard. The project will use the IHE Data Element Exchange (DEX) specification to create the annotated eCRF, the keyCRF, by drawing on metadata in a metadata repository (MDR) such as CDISC's SHARE or the SALUS MDR. The keyCRF can be used to create an extraction specification that pulls instance data from the CCD to pre-populate the eCRF.

Project Leads

Name Role Organization E-mail
Landen Bain Co-Lead CDISC
Gokce B. Laleci Erturkmen Co-Lead SRDC
Frederik Malfait Semantic Technologies IMOS Consulting
Gary Walker CDASH Expert Quintiles
Geoff Low RDF Expert Medidata
Ali Anil Sinaci ISO 11179 and HL& CCD Expert SRDC
Mitra Rocca Regulatory Perspective FDA
George Cole EHR Perspective Allscripts

Project Rationale

The following use case describes the use of keyCRF through the eyes of an end user.

A research forms designer is building a case report form for a particular research study. The designer refers to an on-line metadata registry of research data elements, e.g. SHARE, and selects the desired data elements from a set of research friendly elements such as CDASH, and, using a unique identifier for that data element, retrieves the metadata defined by the metadata registry into an annotated case report form. The metadata includes the exact specification, using XPath, to find the corresponding data element in the HL7 specification Continuity of Care Document (CCD) as extended in the IHE Clinical Research Document (CRD) profile. Using the XPath statements, the research system creates an extraction specification for all elements to be extracted from the CCD. This extraction specification provides a map that enables re-use of the proper data within a CCD with precision and without inappropriate access to extraneous information. The extraction specification could then be used with RFD and Redaction to pre-populate the case report form.

Project Deliverables

keyCRF webinar

The keyCRF team will present a webinar in February of 2015 with the following agenda:

  1. An animated illustration of how an application of keyCRF will transform data capture processes at a healthcare site conducting a clinical study.
  2. A walkthrough of the steps of the keyCRF process showing the role of the 'smart form', the metadata repository, and how the extraction specification applies to the electronic record's export document. XML snippets will explain the technical behind the scenes work.
  3. A discussion of future directions for the keyCRF work. How might RDF change the concept of an extraction specification?

Mapping of HITSP C154 Data Dictionary Data Elements to RDF and XML Representation of CCD

HITSP C32 ( ) describes the HL7/ASTM Continuity of Care Document (CCD) content “in order to promote interoperability between participating systems", in this case between an EHR and research data capture systems.

HITSP C32 marks the elements in CCD document with the corresponding HITSP C154 data elements from HITSP Data Dictionary ( to establish common understanding of the meaning of the CCD elements.

The native representation format of CCD documents are XML, while there are efforts to provide an RDF representation of HITSP C32 for enabling semantic interoperability across systems. The RDF model of HL7 CDA schema provided by SALUS Project is available from: In addition to this, there is a parallel effort to provide an RDF representation of FHIR (Fast Healthcare Interoperability Resources - Resources (

We will maintain the data elements in HITSP C154 Data Dictionary in a metadata repository in conformance to ISO/IEC 11179 meta-model. In this metadata repository the extraction specifications of each HITSP C154 data element from CCD documents will also be stored: XPATH expressions will be given for XML representation of CCD documents, while SPARQL queries will be defined for being able to retrieve the data element instances from a medical summary in CCD RDF model. Through DEX profile, these extraction specifications will be retrievable in a machine processable manner as a part of data element metadata.

Linkage of HITSP C154 Data elements to CDASH RDF

This deliverable, the guts of the project, draws on the team's experts in both research and healthcare. The CDASH RDF model will be imported to a metadata repository, then the semantic links between the CDASH data elements and HITSP C154 Data elements will be defined and maintained in the metadata repository. This mapping will enable creation of an extraction specification from CCD documents which can be used to pull instance data into a waiting eCRF. We will also investigate to define and maintain the extraction specifications of HITSP C154 Data elements from XML and RDF serializations of FHIR Resources in the metadata repository.

Demonstration of pre-population of an eCRF from a CCD

An end-to-end demonstration of keyCRF creation, extraction specification creation, and pre-population of an eCRF will show industry the value of the approach. The demonstration will employ the well-known mechanism of RFD to define the necessary transactions between the EHR and the research system.

Project Related Documents

Date Document Type Document
03 June 2015 Final Presentation (1) Key CRF Demo
03 June 2015 Final Presentation (2) Key CRF

Meeting Materials

Date Presentations Meeting Minutes