Project Scope |
Increasing interest in eSource keeps the issue of data integration between Research Systems (EDC, CTMS, CDMS, etc) and healthcare systems (EHR, etc) as a consistent want for Sponsors of Clinical Investigators and Regulators. Previous efforts to make this a repeatable, scalable solution have not met with |
wide-scale adoption, for a variety of reasons.Some common historical points of view have included:
Many of these issues are on the path to being resolved; |
Potential Solution
Review the HL7 FHIR standard as a basis for future data integrations between Research Systems and Healthcare systems. It will include looking at the existing FHIR based Research standards (including DAF and SDC
Project Lead
Geoff Low
Other Initiatives
CDISC EHR to CDASH (E2C) Group
- The CDISC E2C group is the mechanics or the 'how'; it is predicated on the fact that there is a need for a migration of data from the EHR system to the research system; it has broadened from it's original scope to incorporate the view of the EHR system being the CCD (per RDF) to include FHIR. I think this is an important evolution, there is much more enthusiasm around FHIR than I've seen around any technological healthcare standard - ever!
- The PhUSE group is the why - it's taking a look at the standard (and the initiatives) around FHIR and applying them to a few scenarios within the research domain. The expected output will be a white paper with the conclusions of the group about how FHIR will (or will not, perhaps) change clinical research in the future. There will be subsequent projects that will dig into any of the use cases identified to show Pharma and other stakeholders the utility - these will utilise the rules and mappings put together in the E2C project.
- Follow on from the PhUSE Semantic Technologies keyCRF Project
Recommended Solutions
HL7 have been publishing a new draft standard; Fast Healthcare Interoperability Resources (FHIR). This is an entirely different paradigm, built around Resources and using REST as a architectural style. Thisgovernment programs have pushed the adoption and accessibility of electronic health records. In addition, there are a number of stakeholders in the Research Industry that are making the use of healthcare resources a priority for the future; examples include Transcelerate eSource initiative and HL7 Vulcan Accelerator. |
Project Leads | |
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Geoff Low, Medidata Solutions | |
Nicola Newton, PHUSE Project Assistant |
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Objectives & Deliverables | Timelines |
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Begin work on two new Use Cases | Q2 2023 |
Continue to identify opportunities for presenting and recruiting | Q2 2023 |
Published Deliverables | Date |
Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms Using a CDISC ODM API | 2018 |
Recommended Solutions
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- The publication of the Federal Notice in 2015 and the updated Draft Guidance in 2016 have shown the FDA's commitment to increased adoption of eSource in Clinical Research. In particular, the Draft Guidance showed a renewed focus on bi-directional integration of data between Research and Healthcare systems; something that would not easily be achieved given current technology and processes. FHIR offers the possibility of making this a reality.
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Stakeholders/Initiatives Specific Actions
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