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Microgram: e2c-benefit-risk-change

station__algovigilance__microgram-e2c-benefit-risk-change native (always callable) algovigilance pv-core Constructa Configa

ICH E2C(R2) Section 7: Determines if the benefit-risk balance has changed since the last PBRER based on new safety signals, efficacy changes, and risk minimization effectiveness

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

new_safety_signal booleanrequired — Input variable new_safety_signal
signal_serious boolean — Input variable signal_serious
efficacy_data_changed boolean — Input variable efficacy_data_changed
effect_direction string — Input variable effect_direction
risk_minimization_effective boolean — Input variable risk_minimization_effective
new_indication_approved boolean — Input variable new_indication_approved

Example call

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

{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "station__algovigilance__microgram-e2c-benefit-risk-change",
    "arguments": {
      "new_safety_signal": 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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/tools/algovigilance__microgram-e2c-benefit-risk-change/raw.md — this page's Markdown twin