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 |
|
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. |
Data Element |
---|
Study Name
Description
Study subject is part of |
|
Comment