1. Load the ecosystem | 2. Load evidence | 3. Compute the Submission Confidence Index | 4. Understand what is driving the score | 5. Apply a regulatory authority profile | 6. Compare regulatory authority profiles | 7. Risk assessment | 8. Traceability coverage | 9. Sensitivity analysis | 10. Ingesting real submission artifacts | Define-XML | Pinnacle 21 validation output | Combining sources | 11. Launch the dashboard | Summary — demo data workflow

Supported authorities | Submission types per authority | Creating a submission profile | Comparing authority weights | Profile summary | Validating evidence against a profile | Study phase

Overview | Creating a Run Context | Understanding the Evidence Schema | Controlled vocabulary helpers | Building Evidence with as_evidence() | Validating Evidence | Binding Multiple Evidence Tables | Quick Overview with evidence_summary() | Exporting and Importing Evidence | What's Next

Default configuration | Creating a risk register | Computing risk scores | Applying mitigations | Comparing registers | Integration with r4subcore evidence

Default configuration | Building a trace model | Inspecting the trace model | Computing trace levels | Indicator scores from evidence | Partial mapping (orphans)

Default configuration | Decision bands | Building example evidence | Computing pillar scores | Computing the SCI | Detailed explanation | Sensitivity analysis | Custom weights

Available datasets | Pharma study evidence table | ADaM metadata | SDTM metadata | Traceability mapping | Risk register | Regulatory indicator definitions | Oncology trial datasets