Data Element
Study Name
Description

Study subject is part of
Submitted By: Mitra Rocca / Food and Drug Administration
Data Element Information
Use Case Description(s)
Use Case Description Leverage EHRs to find out, if a patient has been enrolled in a clinical trial. (e.g. COVID-19 trial)
Estimate the breadth of applicability of the use case(s) for this data element Clinical researchers, regulators and medical product manufacturers, patients
Link to use case project page https://www.fda.gov/drugs/coronavirus-covid-19-drugs/covid-19-real-world-data-rwd-data-elements-harmonization-project
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) CDISC standards, HL7 FHIR researchstudy, researchsubject (formerly known as Data Access Framework (DAF))
Additional Specifications https://www.hl7.org/fhir/researchstudy.html
Current Use Not currently captured or accessed with an organization
Extent of exchange N/A
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) None
Restrictions on Use (e.g. licensing, user fees) None
Privacy and Security Concerns None
Estimate of Overall Burden Implement the data elements within the researchsubject in EHR systems.

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