# determine-expedited-reporting

`station__pv-engine__determine-expedited-reporting` · external (needs EXECUTION_BACKEND_URL configured) · domain `pv-engine` · pv-relevance `pv-core`

Determine expedited reporting type and deadline per ICH E2A/E2D and regional requirements. Evaluates seriousness, expectedness, fatality, DME status, and regulatory region to determine: 7-day (FDA IND fatal/life-threatening SUSAR), 15-day (serious unexpected), 90-day (serious expected), or non-expedited. Supports FDA, EMA, PMDA, Health Canada, TGA, MHRA, NMPA regions.

> **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

- `is_serious` *boolean* (required) — Meets ICH E2A seriousness criteria
- `is_unexpected` *boolean* (required) — Not in Reference Safety Information (Company Core Data Sheet)
- `is_fatal` *boolean* — Event resulted in death
- `is_life_threatening` *boolean* — Life-threatening at time of event
- `is_dme` *boolean* — Designated Medical Event (CIOMS VIII)
- `region` *string* — Regulatory region: fda, ema, pmda, hc, tga, mhra, nmpa, ich (default: ich)
- `context` *string* — Report context: clinical_trial, post_marketing, literature, solicited (default: post_marketing)
- `is_study_endpoint` *boolean* — Event is a study endpoint (exempt from expedited reporting)

## Example call

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

{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "station__pv-engine__determine-expedited-reporting",
    "arguments": {
      "is_serious": false,
      "is_unexpected": false
    }
  }
}
```

## Related

- [/tools](/tools) — all 3062 tools
- [/tools/pv-engine__determine-expedited-reporting](/tools/pv-engine__determine-expedited-reporting) — HTML page
- [/tools/pv-engine__determine-expedited-reporting/json](/tools/pv-engine__determine-expedited-reporting/json) — JSON form (agent-friendly)
- [/api/mcp](/api/mcp) — endpoint
- [/AGENTS.md](/AGENTS.md) — agent guide