HCLS/ClinicalObservationsInteroperability/EMR CT

EMR + Clinical Trials


There is great perceived value in being able to work with clinical research data and clinical care data across clinical domains, e.g. health care, pharmaceutical development, pharmcosurveillance. This include the interest to re-use patient data collected in the care context (from EMRs) for data collection points in a clinical research protocol.

Although there is significant overlap in the clinical data content of collected in clinical research and clinical care, the different emerging standard data representations are not taken that into consideration, therefore usage of data across domains is a challenge.

Clinical research data and clinical care data from EMRs have different information models and different terminological standards. CDISC's Study Data Tabulation Model (SDTM), an emerging standard for regulatory reporting of clinical research data, defines the study variables for a given clinical trial in terms of domains and observations. Although many EMRs do not use standards in the modeling of clinical information, there is a large body of work in the Healthcare/Clinical Practice arena where detailed clinical models (DCM) have been developed, e.g. HL7 CDA templates.

The goal of this task is to investigate, and if possible propose, a model that enable re-use of common observation models across the clinical trials and clinical practice contexts. This of course, include how Semantic Web specifications such as RDF/OWL can be leveraged to achieve this.

Task List/Project Plan

  • caBIG Semantic Workflows Prototyping

Face to Face November 2007

Tentative Agenda for F2F in November 2007

ISWC HCLS Tutorial 2008

ISWC HCLS Tutorial 2008




  • Stan Huff, Medical Informatician, Intermountain Healthcare
  • Aaron Kamauu, RemedyMD
  • Jerry Potrado, Roche
  • Charlie Barr, Roche
  • Amit Sheth, Wright State University
  • Joey Coyle, Intermountain Healthcare
  • Jyotishman Pathak, Mayo Clinic
  • Rachel Richesson, South Florida University
  • Bo Andersson, AstraZeneca
  • Kerstin Forsberg, AstraZeneca
  • Chimezie Ogbuji, Cleveland Clinic
  • Yan Heras, Intermountain Healthcare
  • Steve Dobson, Pfizer
  • Vijay Bulusu, Pfizer
  • Susie Stephens, Centocor
  • Miguel Valenzuela, Roche
  • Tom Oniki, GE Healthcare
  • Vipul Kashyap, Partners Healthcare
  • Jennifer Fostel, NIEHS, NIH
  • Landen Bain, CDISC
  • Dan Corwin, Lexikos and SemantxLS
  • Joanne Luciano, Predictive Medicine, Inc.
  • Eric Neumann, Clinical Semantics Group
  • Helen Chen, Agfa Healthcare
  • Dan Russler, Oracle
  • Matt Moores, Oracle
  • Holger Stenzhorn, DERI

Use Case Scenarios

  • Rachel Richesson: Use Case Scenario for Screening Patient Populations for Clinical Trial Eligibility
    • Use Case Document containing Sample Protocols
    • Incorporate Stan Huff's suggestions for use case ... enumerated below:
      • Doing mammography
      • see nodules or calcifications
      • lead to testing ==> breast biopsies
      • estrogen receptor results
      • lump was benign or malignant
      • underlying genetics on BRCA1 gene
      • correlate the genetic makeup with phenotypic observations
      • ... and so on ...
  • Narrow down Choices for Problems/Diagnoses (see Media:HCLS$$ClinicalObservationsInteroperability$UsecaseBackground-EMR-CT-Interop-8-27-07.pdf)
  • Initial Functional Requirements Document by Vipul Kashyap
  • Susie Stephen: Use Case Scneario based on known drugs in the market
    • Need to coordinate with Rachel at some point.
  • Jerry Potrado: Propose a narrowly scoped Clinical Trial Design that involves the above examples
  • Miguel Valenzuela: Propose a use case scenario based on 21 CFR 11 Regulgations that involves the above examples
  • Landen Bain: CDISC High Level Use Case
  • Dan Corwin: Core Requirements for a simple matching web service
  • Dan Corwin: EMR Wrappers a way to install matching predicates on an EMR system
  • Dan Corwin: Search Agents how to automate searches for protocol candidates
  • Dan Corwin: : COI Architecture proposed for a prototype use case web app
  • Ronan Fox: Use Case Scenario for Clinical Trial Patient Recruitment



Last modified on 5 October 2012, at 17:15