# Microgram: fda-rwe-study-fitness

`station__algovigilance__microgram-fda-rwe-study-fitness` · native (always callable) · domain `algovigilance` · pv-relevance `pv-core`

FDA real-world evidence study fitness assessment: routes by RWD source and study design to regulatory acceptability per FDA Guidance 'Considerations for the Use of RWD and RWE' (2023)

## Agent metadata

- `idempotent`: true
- `read_only`: true
- `expected_latency_ms`: unknown (not yet contract-tested)
- `cost_tokens_estimate`: unknown

## Input schema

- `rwd_source` *string* (required) — Real-world data source: ehr, claims, registry, patient_generated, linked_database
- `study_design` *string* (required) — Study design: randomized_rwe, single_arm_external_control, observational_cohort, case_control, cross_sectional
- `regulatory_purpose` *string* — Intended use: new_indication, label_expansion, postmarket_safety, postmarket_effectiveness
- `data_quality_verified` *boolean* — Whether data relevance, reliability, and completeness have been verified

## Example call

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

{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "station__algovigilance__microgram-fda-rwe-study-fitness",
    "arguments": {
      "rwd_source": "",
      "study_design": ""
    }
  }
}
```

## Related

- [/tools](/tools) — all 7718 tools
- [/tools/algovigilance__microgram-fda-rwe-study-fitness](/tools/algovigilance__microgram-fda-rwe-study-fitness) — HTML page
- [/tools/algovigilance__microgram-fda-rwe-study-fitness/json](/tools/algovigilance__microgram-fda-rwe-study-fitness/json) — JSON form (agent-friendly)
- [/api/mcp](/api/mcp) — endpoint
- [/AGENTS.md](/AGENTS.md) — agent guide