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Research Data Evidence

Attach a FHIR-native dataset to the exact measurement conditions behind its quality statement.

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Prove readiness · Decision brief

Attach a dataset to the exact measurement conditions that produced its quality statement — and reproduce that statement years later.

Trigger: Study dataset cut, site onboarding, RWE submission package, or a data-quality question from a reviewer
Evidence: Dataset-quality report with validator version, IG pins, terminology snapshot, thresholds, and SHA-256 integrity hash
Decision: Can this dataset be released, and can its quality claim be defended later?
Validation scope: Selected cohort scope, profiles, terminology basis, and per-site environment

Read the pinned measurement basis
Start from the exact profile package, version, source, and activation state used to measure the dataset.
Measure every site the same way
Run a shared, compatibility-checked validation contract against each contributing site or environment and compare the measured results.
Read the dataset-quality evidence
Close the dataset decision on its immutable scope, reproducibility contract, and content-integrity metadata.

What this evidence supports

Records makes the measurement explicit. Your team still owns the decision.

Supports

A reviewable decision basis

A reproducible FHIR quality claim across dataset cuts, contributing sites, and later reviewer questions.

Does not decide

The governance outcome

Study compliance, GxP qualification, scientific validity, or the fitness of non-FHIR stages such as SDTM.

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Related use cases

Product mechanism

How the release quality loop preserves evidence

See how scope, baselines, findings, reruns, and a final decision stay connected.

Define the dataset-quality contract.

Bring the cohort, profile basis, sites, and release decision the evidence must survive.

Discuss research evidence