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201805 Clinical Research Track

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Track Name

Clinical Research

Submitting WG/Project/Implementer Group

Biopharma FHIR Project Group

Justification

This track will continue to evaluate use of FHIR for clinical research of new biopharmaceutical experimental treatments, seeking to advance the use of FHIR resources as eSource data used to pre-populate clinical research case report forms for both regulated and non-regulated clinical research. Plans for this connection include participation from at least 3 clinical data system implementers and pharmaceutical companies. 3 detailed use case scenarios will be proposed, 2 of which build on prior work at previous connectathons, and one exploring a new area for writing back with updates to clinical data from a clinical system. This work will inform development of profiles and IGs to support clinical research using FHIR, which will likely inform projects of the BR&R workgroup.

Clinical Research studies currently require the redundant entry of clinical data that already typically reside in Meaningful Use conformant EHR systems. EHR data represents original records in electronic format that can be used as eSource and directly imported into clinical research EDC databases so as to improve the quality and consistency of data between EHR and EDC systems and eliminate the need for redundant data entry. Establishing interoperability between EHR and EDC systems to streamline and modernize clinical investigations should improve data accuracy, patient safety, and clinical research efficiency. Given the extreme cost and extended time required for randomized clinical trials, it would be substantially better to utilize EHR source data to directly populate clinical trial databases wherever feasible. As stated in its May 2016 FDA draft guidance titled “Use of Electronic Health Record Data in Clinical Investigations” FDA “encourages sponsors and clinical investigators to work with the entities that control the EHRs, such as health care organizations, to use EHRs and EDC systems that are interoperable. . . Establishing interoperability between EHR and EDC systems to streamline and modernize clinical investigations should improve data accuracy, patient safety, and clinical research efficiency.”


Proposed Track Lead

See Connectathon_Track_Lead_Responsibilities Geoff Low, Medidata

Expected participants

Medidata, UCB, Parexel

Roles

Please include information here regarding how much advance preparation will be required if creating a client and/or server.

Role 1 Name

Scenarios

Scenario Step 1 Name

Action:
Precondition:
Success Criteria:
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TestScript(s)

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