{"mcpName":"station__microgram__run-fda-sponsor-ind-safety","slug":"microgram__run-fda-sponsor-ind-safety","label":"run-fda-sponsor-ind-safety","description":"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","domainSlug":"microgram","pvRelevance":"pv-core","backend":"external","agentMetadata":{"idempotent":null,"read_only":null,"expected_latency_ms":null,"cost_tokens_estimate":null,"pipes_to":null},"inputSchema":{"type":"object","properties":{"fatal_or_life_threatening":{"type":"boolean","description":"Input parameter: fatal_or_life_threatening"},"study_type":{"type":"string","description":"Input parameter: study_type"},"suspected_adverse_reaction":{"type":"boolean","description":"Input parameter: suspected_adverse_reaction"},"unexpected":{"type":"boolean","description":"Input parameter: unexpected"},"serious":{"type":"boolean","description":"Input parameter: serious"}},"required":["fatal_or_life_threatening","study_type","suspected_adverse_reaction","unexpected","serious"]},"example":null,"taxonomy":{"rank":{"domain":"Substrata","kingdom":"Constructa","phylum":"Configa","class":"station-config","order":"microgram","family":"mcp-tool-config"},"characteristics":{"substrate":"config","domain":"pv","lifecycle":"continuous","stateful":false,"persistence":"none","authority":"read","compounding":"producer","io_input":"agent-request","io_output":"tool-response"}},"_links":{"html":"/tools/microgram__run-fda-sponsor-ind-safety","markdown":"/tools/microgram__run-fda-sponsor-ind-safety/raw.md","invoke":"/api/mcp","catalog":"/api/mcp"}}