Data Readiness
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54 profiles ·
source-checked 13 Jul 2026

Data model / schema · Public repository tag v8.2.2 · 2025-02-27

Sentinel Common Data Model

Maintained by Sentinel Operations Center · FDA Sentinel Initiative

What it helps you do

Use Sentinel CDM when you need nineteen linked tables supporting standardized queries over enrollment, encounters, diagnoses, procedures, dispensing, prescribing, laboratory, death, patient-reported, and feature-engineering data.

  • Real-world evidence
  • Regulatory
PlanAcquireHarmonizeExchangeLearn + reuse

01

Where it fits—and where it doesn’t

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.
Do not use it as
Do not treat Sentinel CDM as a complete solution on its own. 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
Teams working with Real-world evidence and Regulatory data across Harmonize → Learn + reuse.
Maturity
EstablishedEstablished enough for serious use; still pin the exact release and any implementation profile.

02

See it in the workflow

A standard creates value by changing a handoff, not by existing in a catalog.

  1. InputWhat starts

    Real-world evidence and Regulatory data, metadata, and the local decisions around them

  2. Sentinel CDMWhat changes

    Sentinel CDM applies a shared data model / schema across Harmonize → Learn + reuse

  3. OutputWhat becomes possible

    A more consistent, reviewable handoff for the next system or team

Readiness gateBefore scaling: 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.

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.

05

Implementation starter

Start with one bounded handoff. Pin, test, and review it before scaling.

  1. Name an accountable owner and the decision Sentinel CDM must support.

  2. Pin the exact version and companion artifacts: Public repository tag v8.2.2 · 2025-02-27.

  3. Map one representative input to the required data model / schema artifacts.

  4. Test the result against the canonical source and record every exception.

  5. Preserve the source data, mappings, and review evidence before scaling.

06

Limitation to test first—and the tests that catch it

Risk

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.

Test

Run one representative end-to-end pilot and record exactly where Sentinel CDM loses context, needs an extension, or depends on another standard.

Risk

A structured or machine-readable result can still be unfit for analysis or AI.

Test

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

Why we believe this

Checked against the canonical source plus independent operational evidence from an adopter, regulator, or implementation report.

Evidence notation: E1 + E2. The code is shorthand; the plain-language statement above is the claim.

Formal status
Public repository latest tag v8.2.2; operational deployment mix not verified
Confidence
Medium
Review state
Source-checked · watch
Reviewed by
Regulatory RWD surveillance reviewer
Last verified
13 July 2026
Review again when
Repository tag, landing-page reconciliation, quality-program, or routine-query release
How the evidence method works

08

Source shelf

Official diagrams, examples, specifications, and explainers. Nothing external loads until you choose to open it.

  • Primary sourcePublic repository tag v8.2.2 · 2025-02-27

    Sentinel CDM v8.2.2 public repository tag

    The canonical publisher or steward source used to verify this data model / schema profile.

    Publisher
    Sentinel Operations Center · FDA Sentinel Initiative
    Rights
    Rights remain with the publisher; this knowledge base links to the source rather than copying it.
    Access
    Opens the publisher's source in a new tab; no external media loads on this page.
    Verified
    2026-07-13
    Open at source

Next action

Put this profile in context

Compare its role with adjacent standards or place it inside an end-to-end data pathway before choosing an implementation.