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run-e2c-benefit-risk-change

station__microgram__run-e2c-benefit-risk-change external (needs EXECUTION_BACKEND_URL) microgram 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	`microgram`
family	`mcp-tool-config`

Characteristics:

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

Input schema

efficacy_data_changed booleanrequired — Input parameter: efficacy_data_changed
effect_direction stringrequired — Input parameter: effect_direction
risk_minimization_effective booleanrequired — Input parameter: risk_minimization_effective
new_safety_signal booleanrequired — Input parameter: new_safety_signal
signal_serious booleanrequired — Input parameter: signal_serious
new_indication_approved booleanrequired — Input parameter: new_indication_approved

Example call

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

{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "station__microgram__run-e2c-benefit-risk-change",
    "arguments": {
      "efficacy_data_changed": false,
      "effect_direction": "",
      "risk_minimization_effective": false,
      "new_safety_signal": false,
      "signal_serious": false,
      "new_indication_approved": 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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