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Microgram: fda-sponsor-ind-safety

station__algovigilance__microgram-fda-sponsor-ind-safety native (always callable) algovigilance pv-core Constructa Configa

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

Taxonomy

Linnaean classification joined from the algovigilance taxonomy index via the parent config's rank.

Rank	Value
domain	`Substrata`
kingdom	`Constructa`
phylum	`Configa`
class	`station-config`
order	`algovigilance`
family	`mcp-tool-config`

Characteristics:

substrate: config
domain: pv
lifecycle: continuous
authority: read
compounding: producer
io: agent-request → tool-response

Input schema

suspected_adverse_reaction booleanrequired — Whether there is a reasonable possibility the drug caused the event
serious booleanrequired — Whether the event meets serious criteria per 21 CFR 312.32(a)
unexpected booleanrequired — 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

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
    }
  }
}

How to invoke from a client

From any MCP-aware client, add https://algovigilance.com/api/mcp as an MCP server, then call this tool by name. From a raw HTTP client, send the JSON-RPC body above to /api/mcp.

Agent-friendly formats

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