| 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) |
| Estimated number of stakeholders capturing, accessing using or exchanging | 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 |
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| 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 |
| Number of organizations/individuals with which this data element has been electronically exchanged | 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 |
Information from the submission form |
|---|---|
| status |
Description
candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
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