# run-fda-e19-selective-safety

`station__microgram__run-fda-e19-selective-safety` · external (needs EXECUTION_BACKEND_URL configured) · domain `microgram` · 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)

> **Note:** This tool routes through an external execution backend. If `EXECUTION_BACKEND_URL` is unset on the server, calls return JSON-RPC error `-32603 "Tool execution backend not configured"`. Tools with `backend: native` execute in-process and are always callable.

## Agent metadata

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

## Input schema

- `population_differs` *boolean* (required) — Input parameter: population_differs
- `well_characterized_safety` *boolean* (required) — Input parameter: well_characterized_safety
- `trial_phase` *string* (required) — Input parameter: trial_phase
- `prior_safety_database` *string* (required) — Input parameter: prior_safety_database

## Example call

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

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

## Related

- [/tools](/tools) — all 3062 tools
- [/tools/microgram__run-fda-e19-selective-safety](/tools/microgram__run-fda-e19-selective-safety) — HTML page
- [/tools/microgram__run-fda-e19-selective-safety/json](/tools/microgram__run-fda-e19-selective-safety/json) — JSON form (agent-friendly)
- [/api/mcp](/api/mcp) — endpoint
- [/AGENTS.md](/AGENTS.md) — agent guide