{
  "id": "workflow:drug-trial-protocol-review",
  "_kind": "Workflow",
  "_file": "workflows/workflows/workflows-pharma.yaml",
  "_cluster": "workflows",
  "attributes": {
    "displayName": "Drug Trial Protocol Review",
    "workflowKind": "governance",
    "triggerType": "event-driven",
    "typicalCadence": "per-trial-phase",
    "complexity": "cross-team",
    "description": "Reviews clinical trial protocol design and amendments -- evaluating\nprimary and secondary endpoint definitions for statistical power,\nvalidating inclusion/exclusion criteria against target patient\npopulation feasibility, assessing randomization and blinding\nmethodology, reviewing informed consent documents for regulatory\ncompleteness, verifying protocol alignment with ICH-GCP guidelines and\nIRB requirements, and analyzing site selection criteria against\nenrollment projections. Produces protocol review reports, feasibility\nassessments, and amendment impact analyses. Excludes patient enrollment\nexecution.\n"
  },
  "outgoingEdges": [
    {
      "from": "workflow:drug-trial-protocol-review",
      "to": "role:data-scientist",
      "kind": "involves_role",
      "attributes": {}
    },
    {
      "from": "workflow:drug-trial-protocol-review",
      "to": "role:security-reviewer",
      "kind": "involves_role",
      "attributes": {}
    },
    {
      "from": "workflow:drug-trial-protocol-review",
      "to": "role:principal-engineer",
      "kind": "involves_role",
      "attributes": {}
    },
    {
      "from": "workflow:drug-trial-protocol-review",
      "to": "skill-area:python-data-pipelines",
      "kind": "requires_skill_area",
      "attributes": {}
    },
    {
      "from": "workflow:drug-trial-protocol-review",
      "to": "skill-area:domain-driven-design",
      "kind": "requires_skill_area",
      "attributes": {}
    },
    {
      "from": "workflow:drug-trial-protocol-review",
      "to": "domain:pharmaceuticals",
      "kind": "applies_to_domain",
      "attributes": {}
    },
    {
      "from": "workflow:drug-trial-protocol-review",
      "to": "domain:compliance",
      "kind": "applies_to_domain",
      "attributes": {}
    },
    {
      "from": "workflow:drug-trial-protocol-review",
      "to": "responsibility:review-architecture-changes",
      "kind": "triggers_responsibility",
      "attributes": {}
    },
    {
      "from": "workflow:drug-trial-protocol-review",
      "to": "responsibility:regulatory-filing",
      "kind": "triggers_responsibility",
      "attributes": {}
    },
    {
      "from": "workflow:drug-trial-protocol-review",
      "to": "org-unit:compliance-team",
      "kind": "performed_by_org_unit",
      "attributes": {}
    },
    {
      "from": "workflow:drug-trial-protocol-review",
      "to": "org-unit:research-engineering",
      "kind": "performed_by_org_unit",
      "attributes": {}
    }
  ],
  "incomingEdges": []
}