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determine-expedited-reporting

station__pv-engine__determine-expedited-reporting external (needs EXECUTION_BACKEND_URL) pv-engine pv-core Constructa Configa

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.

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	`guardian`
family	`mcp-tool-config`

Characteristics:

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

Input schema

is_serious booleanrequired — Meets ICH E2A seriousness criteria
is_unexpected booleanrequired — 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

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
    }
  }
}

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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