# Microgram: fda-sponsor-ind-safety

`station__algovigilance__microgram-fda-sponsor-ind-safety` · native (always callable) · domain `algovigilance` · 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

## Agent metadata

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

## Input schema

- `suspected_adverse_reaction` *boolean* (required) — Whether there is a reasonable possibility the drug caused the event
- `serious` *boolean* (required) — Whether the event meets serious criteria per 21 CFR 312.32(a)
- `unexpected` *boolean* (required) — Whether the event is not listed in the Investigator Brochure
- `fatal_or_life_threatening` *boolean* — Whether the event resulted in death or was life-threatening
- `study_type` *string* — Type of study: ind, ba_be, ba_be_ind_exempt

## Example call

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

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

## Related

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