{
  "id": "lib-process:biomedical-engineering--clinical-study-design",
  "_kind": "LibraryProcess",
  "_file": "generated-library/processes.yaml",
  "_cluster": "generated-library",
  "attributes": {
    "displayName": "clinical-study-design",
    "description": "Clinical Study Design and Execution - Design and execute clinical studies for medical device\napproval including IDE studies, pivotal trials, and post-market studies.",
    "libraryPath": "library/specializations/domains/science/biomedical-engineering/clinical-study-design.js",
    "specialization": "biomedical-engineering",
    "references": [
      "- FDA IDE Regulations 21 CFR 812\n- ISO 14155:2020 Clinical Investigation of Medical Devices\n- ICH E6(R2) Good Clinical Practice"
    ],
    "example": "const result = await orchestrate('specializations/domains/science/biomedical-engineering/clinical-study-design', {\n  studyName: 'IMPACT Trial',\n  deviceName: 'Transcatheter Aortic Valve',\n  studyType: 'Pivotal RCT',\n  regulatoryPath: 'PMA'\n});",
    "usesAgents": [
      "general-purpose"
    ]
  },
  "outgoingEdges": [
    {
      "from": "lib-process:biomedical-engineering--clinical-study-design",
      "to": "skill-area:data-analysis",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--clinical-study-design",
      "to": "skill-area:sensor-fusion",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--clinical-study-design",
      "to": "skill-area:statistical-analysis",
      "kind": "lib_requires_skill_area",
      "attributes": {
        "weight": 0.5
      }
    },
    {
      "from": "lib-process:biomedical-engineering--clinical-study-design",
      "to": "domain:biomedical-engineering",
      "kind": "lib_applies_to_domain",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--clinical-study-design",
      "to": "role:biomedical-engineer",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--clinical-study-design",
      "to": "role:research-engineer",
      "kind": "lib_involves_role",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--clinical-study-design",
      "to": "workflow:experiment-design",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 1
      }
    },
    {
      "from": "lib-process:biomedical-engineering--clinical-study-design",
      "to": "workflow:peer-review-cycle",
      "kind": "lib_implements_workflow",
      "attributes": {
        "weight": 0.7
      }
    },
    {
      "from": "lib-process:biomedical-engineering--clinical-study-design",
      "to": "specialization:biomedical-engineering",
      "kind": "lib_belongs_to_specialization",
      "attributes": {
        "weight": 0.9
      }
    }
  ],
  "incomingEdges": []
}