The inputs | One call to a score | Reading the score | The gap, made actionable | Scoring more of the package | Takeaways

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

Default configuration | Building a trace model | Inspecting the trace model | Computing trace levels | Indicator scores from evidence | Partial mapping (orphans) | Coverage report for the ADRG | Multi-step derivation chains | Focusing on the problems

Default configuration | Decision bands | Building example evidence | Computing pillar scores | Computing the SCI | Detailed explanation | Sensitivity analysis | Custom weights | Confidence intervals | Critical findings cap the band | Tracking readiness over time

A Pinnacle 21 export | Reading the report | Converting to evidence

The columns | Controlled vocabularies | Run context | Validation | Schema versioning

The evidence | The score | Where the score comes from | Is the score stable? | What this answers

The inputs | Building the model | Trace levels | Coverage as indicators

The register | The risk picture | Working the highest risks | Before and after | Feeding the readiness score

Default configuration | Creating a risk register | Computing risk scores | Applying mitigations | Comparing registers | Integration with r4subcore evidence | Reduction summary | Risk heatmap | Alternative risk models

What can and cannot be validated | A worked evidence table | Construct validity: the score responds to degradation | Discriminant validity: clean and broken packages separate | Concurrent validity: agreement with an independent count | Robustness: stability under alternative weights | A calibration finding | The limit of this validation | What a predictive study would need

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

The metadata contract | Evidence from metadata | Evidence from an ADaM dataset | One call to a score | How the pieces map to the SCI

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

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