# Microgram: fda-e19-selective-safety

`station__algovigilance__microgram-fda-e19-selective-safety` · native (always callable) · domain `algovigilance` · pv-relevance `pv-core`

ICH E19 selective safety data collection scope: routes by trial phase and prior data availability per ICH E19 'A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials' (2022)

## Agent metadata

- `idempotent`: true
- `read_only`: true
- `expected_latency_ms`: unknown (not yet contract-tested)
- `cost_tokens_estimate`: unknown

## Input schema

- `trial_phase` *string* (required) — Trial phase: late_phase3, phase3b, phase4, post_approval_commitment
- `prior_safety_database` *string* (required) — Size of prior safety database: large_adequate, moderate, limited
- `well_characterized_safety` *boolean* (required) — Whether the safety profile is well-characterized from prior development
- `population_differs` *boolean* — Whether trial population significantly differs from prior studied population

## Example call

```json
POST /api/mcp
Content-Type: application/json

{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "station__algovigilance__microgram-fda-e19-selective-safety",
    "arguments": {
      "trial_phase": "",
      "prior_safety_database": "",
      "well_characterized_safety": false
    }
  }
}
```

## Related

- [/tools](/tools) — all 7718 tools
- [/tools/algovigilance__microgram-fda-e19-selective-safety](/tools/algovigilance__microgram-fda-e19-selective-safety) — HTML page
- [/tools/algovigilance__microgram-fda-e19-selective-safety/json](/tools/algovigilance__microgram-fda-e19-selective-safety/json) — JSON form (agent-friendly)
- [/api/mcp](/api/mcp) — endpoint
- [/AGENTS.md](/AGENTS.md) — agent guide