VigiCore Signal Automation

Workspace summary

Signal detection and validation workspace

Create controlled signal runs, approve column mappings, review calculated outputs, generate audit-ready reports, and manage follow-up validation evidence.

Current User Pending Tenant pending

Tracked Runs 0 Saved in the tenant run register

Selected Run None No run selected

Records Integrity Controlled Cloud Storage Primary controlled storage with optional secondary archive

Authentication

Session and token profile

Frontend mode

Loading auth configuration...

Token state

Loading token state...

Security

Runtime controls

Security controls are unavailable until the session is established.

Recent runs

Run register

Run ID	Client	Status	Source System	Data Cutoff	Action
No runs loaded.

Step 1

Initialize run

Step 2

Upload source file

No run selected

No source file uploaded for the selected run.

Detected profile

Source inspection

Detected sheets

Not available

Detected columns

Not available

Mapping policy

Execution prerequisites

Required mappings: Case ID, Product / Drug, and Event PT.

Optional fields improve traceability and report richness, but the required mappings must be confirmed before execution.

Mapping approval

Approve columns and execute

Source sheet Report filter

Run target

Mapped output is standardized before entering the validated signal calculation engine.

Case ID Product / Drug Event PT Case type Report source Country Priority Receipt / chronology Case version

Source preview

Top source rows

Upload a file to inspect the detected source preview.

Signal settings

Current calculation controls

Minimum N Minimum PRR Minimum ROR Minimum Chi-square Minimum PRR LB Reactivation PRR Delta Comparator Stability Threshold Stability Warning Shrinkage Method EB05 Threshold Bayesian Alpha Bayesian Beta IC025 Threshold Enable Bayesian/IC Mode Priority Mapping P1 Priority Mapping P2 Priority Mapping P3 Priority Mapping P4 Priority Mapping P5 Spontaneous source terms (comma-separated) INI case-type terms (comma-separated) FU case-type terms (comma-separated) External evidence policy Enable FAERS/openFDA checks

Configuration scope

Reviewer-controlled parameters

Thresholds, mappings, Bayesian options, case/source classifications, and external evidence policy are tenant-managed and applied automatically to new staged run executions unless overridden with run-level thresholds.

Results context

Selected run summary

No run executed yet for the selected record.

Run selector

Load saved run

Select run

Results preview

Evaluated Drug-Event pairs

	Drug	Event PT	N	Serious	PRR	ROR	Chi-square	PRR LB	Status	Stability	Bayesian View
Execute or load a run to preview signal output here.

Run analytics

Current summary metrics

Select run for analytics

Load a run to review signal, sparse-data, and comparison-ready summary metrics.

Analytics status

Run interpretation context

Analytics reflect selected run context, signal totals, sparse-data impact, and run-level comparison-safe summaries used during workflow review.

Historical runs

Saved run inventory

Run ID	Client	Status	Source System	Data Cutoff	Action
No runs loaded.

Comparison

Generate comparison report

Comparison outputs will appear here once two runs are selected.

Generated outputs

Run reports and parity results

Run report and parity validation outputs will appear here.

Run ID	Client	Artifact	Storage reference
No generated reports are listed yet.

Report retention

Primary and archive destinations

Primary system of record: controlled cloud report storage.

Secondary archive path: optional enterprise archive integration when enabled.

Validation

Internal case-series validation module

Select one DEC from Results Viewer to continue.

Select one internally flagged DEC from Results Viewer, then upload the target line listing and narrative listing to generate an internal case review validation package.

Literature search

PubMed validation module