01
Where it fits and where it does not
Use these four checks before committing implementation time.
- Use it when
- Research applications retrieving RWD from FHIR-capable EHRs through a named, testable research profile rather than unconstrained base resources.
- Limits
- STU1 is limited to retrospective EHR RWD; prospective eSource, registries, payer data, downstream transformation, and analysis readiness are outside current scope.
- Best for
- Clinical and Real-world evidence and Regulatory teams working across Acquire → Exchange.
- Maturity
- ScalingUsable now, but adoption or tooling is still developing. Pilot the exact stack first.
02
See it in the workflow
This view shows the input, the change the standard introduces, and the resulting output.
- InputWhat starts
Clinical and Real-world evidence and Regulatory source data, metadata, and local mappings
- Vulcan RWD IGWhat changes
Use Vulcan RWD IG as a pinned metadata profile across Acquire → Exchange
- OutputWhat becomes possible
A handoff the next system or team can validate against the same release
03
A concrete example
A research service applies the guide’s cohort searches and must-support elements to retrieve versioned condition, medication, observation, and encounter data from an EHR.
Why it matters: A constrained retrieval contract improves reproducibility, but FHIR output still needs terminology normalization, longitudinal modeling, quality evidence, and bias assessment.
04
What it fits with
Builds on International Patient Access and can combine with jurisdictional core guides; downstream CDISC or OMOP conversion is handled by separate mappings.
- Governance frameworkICH E6(R3)
Both support Clinical and Regulatory and Real-world evidence work and meet around Acquire, Exchange. Compare their roles before treating them as interchangeable.
Explore relationship - StandardFHIR®
Both support Clinical and Real-world evidence work and meet around Acquire, Exchange. Compare their roles before treating them as interchangeable.
Explore relationship - StandardCDISC ODM
Both support Clinical and Regulatory work and meet around Acquire, Exchange. Compare their roles before treating them as interchangeable.
Explore relationship - TerminologyLOINC
Both support Clinical and Real-world evidence work and meet around Acquire, Exchange. Compare their roles before treating them as interchangeable.
Explore relationship
05
Implementation starter
Start with one bounded handoff. Pin, test, and review it before scaling.
Define one handoff, its accountable owner, and the decision Vulcan RWD IG must support.
Pin the exact version and companion artifacts: 1.0.0 · STU1 · FHIR R4 · active 2023-05-26.
Map one representative input to the required metadata profile artifacts.
Test the result against the canonical source and record every exception.
Preserve the source data, mappings, and review evidence before scaling.
06
Test the main limitation
STU1 is limited to retrospective EHR RWD; prospective eSource, registries, payer data, downstream transformation, and analysis readiness are outside current scope.
Run one representative end-to-end pilot and record exactly where Vulcan RWD IG loses context, needs an extension, or depends on another standard.
Machine-readable output may still be unfit for analysis or ML.
Test the output for missing context, provenance, terminology alignment, time leakage, and the intended downstream decision. A constrained retrieval contract improves reproducibility, but FHIR output still needs terminology normalization, longitudinal modeling, quality evidence, and bias assessment.
07
Official resources
Specifications, diagrams, examples, and guides from the organizations that maintain them.
HL7 Vulcan RWD IG 1.0.0
Official publisher or steward guidance for this metadata profile profile.
- Publisher
- HL7 Biomedical Research & Regulation Work Group · Vulcan