Project ScopeIncreasing 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; government 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) | |
Katie Warren (PHUSE Project Assistant) |
Objectives & Deliverables | Timelines | ||
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Review FHIR Specification for applicability as a Research Standard | Q12021 | ||
Identify 3-6 use cases which illustrate how FHIR Resources can enable effective data sharing between Healthcare and Research Systems | Q12021 | ||
Presentation at FHIR DeyDays | Q22022 | ||
May FHIR Connectathon | Q22022 | ||
FHIR DeyDays | Q2 2022 | ||
September Connectathon | Q3 2022 | ||
EU Connect | Q4 2022 | ||
Implementation Guide for SoA | Q2 2023 | IG for ballot | Q12023 |
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Planning for September Connectathon is ongoing. Aiming on refocussing from prev use case to next. Need implementation support from EHR vendors Developing relationship with Vulcan Coordinating with Real World Evidence team (Vulcan) |
Published Deliverables | Date |
Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms Using a CDISC ODM API | 2018 |
Project Members | Organisation |
---|---|
Aditya Gadiko | MMS |
Andy Richardson | Zenetar |
Barbara Blockley | Industry |
Dan Li | Sanofi |
Denzin Coskun | Industry |
Greg Jones | Oracle Health Sciences |
Hugh Glover | Blue Wave Informatics |
Ingeborg Holt | IBM |
Project Members | Organisation |
Jeff Abolafia | Pinnacle 21 |
Jozef Aerts | XML4Pharma |
Michael Ward | Eli Lilly |
Mike Hamidi | Pfizer |
Raj Sodhi | Amgen |
Ramaiah Muvvala | Inductive Quotient Analytics |
Rebecca Baker | CDISC |
Rahul Thandavan | Roche |
Scott Bahlavoon | Nektar |
Stacy Tegan | TransCelerate BioPharma Inc |
Warda Saeed | Eli Lilly |
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