November 28th 2017 Minutes

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Attendees: Eric, Trisha, Ingeborg, Michael, Sharon, Lauren, Paul, Rebeka, Bob, Karnika, Srinivas, Josephine, Rinki

Apologies: Bharath

DV Update

  • Last three weeks all projects have had a call and working on individual projects.
  • Would like as much participation as possible at CSS and Connect.


  • Presentation from Trisha Simpson who leads the PhUSE FHIR group
  • FHIR = Fast HealthCare Interoperability Reasource
  • We are going to continue to work with FHIR to see how difficult it is to pull out the CRFs and data sets and to get a bi-directional data integration
  • FHIR Highlights
  • Easy to learn
  • Data is organised as resources
  • Machine and human readable
  • Easier to find and access

  • We learned that FHIR resources can be used in CDASH and SDTM
  • Some CDASH and SDTM data will still need to be entered
  • HER’s typically use SNOMED, ICD-10 and LOINC
  • CDASH and SDTM do not have specific variables for Encounter type- this addition should be considered
  • Controlled terminology is typically not harmonised

Next Steps for FHIR

  • FHIR only allows for data subscriptions, or data queries- these can be used to extract only the data needed and for real time data access
  • Look into the use of ODM extension to populate CDASH CRFs
  • Additional FHIR extensions to better support research
  • Look at the controlled terminology to use EHR data as esource
  • Utilise the new FHIR resources which are at maturity level 0 and see how useful they will be in our next pilot
  • Plans for Best Practices for Interactive Analyses for Decision Making
    • Paul and Mike to follow up with OSI office
    • Making progress need more support from FDA
    • How can we reach out to FDA to see if they are interested in participating in a pilot
    • Focus on a realistic goal for this year


  • Mike to follow up with OSI to gain support for Sharon's team