MedGaugeE.2 Drug and device R&D Active
Third-party evaluation for drug and device development, including clinical trial matching, literature evidence and verification of registration dossiers, composed from D.5, D.6 and D.10. Graded by before-and-after comparison of coverage, error detection rate and report consistency.
Evidence: none. No benchmark card lists this capability yet. No level is issued: methodology 0.1.0 sets no level thresholds. For scenario capabilities the state is derived from the D-domain capabilities they are composed of (the lowest among them); levels for E are issued only by signed L5 override.
- Domain
- E · Scenario
- Evidence form
- program
- Veto constraints
- —
- Depends on
- D.5 Bioinformatics QC and recomputationD.6 Guideline evidence verificationD.10 Research assistance
- Required by
- —
- Internal task families
- —
- External anchors
- —
- Version
- 0.1.0 · 0.1.0
Definition in detail
Third-party evaluation in drug and device development requires coverage, error detection and consistent reports across trial matching, literature evidence and dossier verification.
Inputs a task gives
- Baseline measurements of coverage, error detection and report consistency
- Eligibility criteria with candidate record sets
- Literature sets and dossier sections with cited evidence
- Workflow materials for the component capabilities D.5, D.6 and D.10
Artifact required
The component artifacts defined by D.5, D.6 and D.10, and a scenario run record with indicator values before and after and links to the component result records.
How it is graded
Graded by before-and-after scenario indicators: coverage, error detection rate and report consistency, computed by program from the run record against the baseline. Levels L1 to L4 are to be derived by program from verified result records once their thresholds are set; methodology 0.1.0 sets none and issues no level. L5 (role candidate) is never derived: it requires written before-and-after evidence on the scenario indicators and external anchors pointing the same way, and is granted only by a signed level override in registry/level-overrides with evidence links and the signer named.
In scope
- Trial matching, literature evidence and dossier verification as one workflow
- Consistency of reports across repeated runs
Out of scope
- Scoring of each component artifact - graded under D.5, D.6 and D.10
- Regulatory classification of a product built on the scenario - recorded in regulatory_context, not graded
Typical failures
Expected failure patterns; not measured rates.
- Coverage gains offset by unverifiable entries that reviewers must check
- Report conclusions that change between runs on the same material
- Error detection measured on a different item mix before and after
Standards: std-medgauge-capability-framework
Benchmarks
No benchmark card lists this capability.
Grading references
No grading reference is mapped to this capability.