01
Where it fits and where it does not
Use these four checks before committing implementation time.
- Use it when
- FDA-style distributed active surveillance of drugs, biologics, devices, and vaccines using partner-held healthcare data.
- Limits
- The public repository’s latest tag is v8.2.2 while the landing page still names v8.1.0 and v8.2.0 concurrently; the current partner deployment mix is not publicly verified.
- Best for
- Real-world evidence and Regulatory teams working across Harmonize → Learn + reuse.
- Maturity
- EstablishedSuitable for production assessment. Pin the exact release and any implementation profile.
02
See it in the workflow
This view shows the input, the change the standard introduces, and the resulting output.
- InputWhat starts
Real-world evidence and Regulatory source data, metadata, and local mappings
- Sentinel CDMWhat changes
Use Sentinel CDM as a pinned data model / schema across Harmonize → Learn + reuse
- OutputWhat becomes possible
A handoff the next system or team can validate against the same release
03
A concrete example
A data partner maps claims and clinical sources into the pinned SCDM, passes Sentinel quality review, and runs centrally distributed surveillance programs locally.
Why it matters: The distributed model supports reproducible safety features, but portability, labeling, site shift, privacy, and algorithm execution must follow Sentinel governance.
04
What it fits with
Shares source code systems with other RWD models but is optimized for Sentinel tools and surveillance workflows rather than general OMOP or PCORnet analytics.
- Governance frameworkICH E6(R3)
Both support Regulatory and Real-world evidence work and meet around Harmonize, Learn + reuse. Compare their roles before treating them as interchangeable.
Explore relationship - Governance frameworkICH M14
Both support Real-world evidence and Regulatory work and meet around Harmonize, Learn + reuse. Compare their roles before treating them as interchangeable.
Explore relationship - Data model / schemaOMOP CDM
Both support Real-world evidence work and meet around Harmonize, Learn + reuse. Compare their roles before treating them as interchangeable.
Explore relationship - TerminologyLOINC
Both support Real-world evidence work and meet around Harmonize, Learn + reuse. 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 Sentinel CDM must support.
Pin the exact version and companion artifacts: Public repository tag v8.2.2 · 2025-02-27.
Map one representative input to the required data model / schema 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
The public repository’s latest tag is v8.2.2 while the landing page still names v8.1.0 and v8.2.0 concurrently; the current partner deployment mix is not publicly verified.
Run one representative end-to-end pilot and record exactly where Sentinel CDM 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. The distributed model supports reproducible safety features, but portability, labeling, site shift, privacy, and algorithm execution must follow Sentinel governance.
07
Official resources
Specifications, diagrams, examples, and guides from the organizations that maintain them.
Sentinel CDM v8.2.2 public repository tag
Official publisher or steward guidance for this data model / schema profile.
- Publisher
- Sentinel Operations Center · FDA Sentinel Initiative