# run-fda-sponsor-ind-safety

`station__microgram__run-fda-sponsor-ind-safety` · external (needs EXECUTION_BACKEND_URL configured) · domain `microgram` · pv-relevance `pv-core`

FDA sponsor IND safety reporting assessment: determines reporting obligation from event characteristics per FDA Guidance 'Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies' (2025) and 21 CFR 312.32

> **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

- `fatal_or_life_threatening` *boolean* (required) — Input parameter: fatal_or_life_threatening
- `study_type` *string* (required) — Input parameter: study_type
- `suspected_adverse_reaction` *boolean* (required) — Input parameter: suspected_adverse_reaction
- `unexpected` *boolean* (required) — Input parameter: unexpected
- `serious` *boolean* (required) — Input parameter: serious

## Example call

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

{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "station__microgram__run-fda-sponsor-ind-safety",
    "arguments": {
      "fatal_or_life_threatening": false,
      "study_type": "",
      "suspected_adverse_reaction": false,
      "unexpected": false,
      "serious": false
    }
  }
}
```

## Related

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