Data Model

Structured Research Data Model

The Intelligence Layer converts response-level symptom scores into structured, exportable research data — ready for registry integration, RWE reporting, sponsor summaries, and downstream statistical analysis.

Export Schema (simplified)

{
  "instrument": "CARE-NFL-PRO-v2.0",
  "respondent_type": "patient | caregiver | clinician",
  "visit": "baseline | follow_up",
  "domains": [
    {
      "domain_id": "cognition",
      "domain_label": "Cognition",
      "score": 0,
      "severity_band": "Mild | Moderate | Severe | Very Severe",
      "questions": [
        {
          "question_id": "q_cog_01",
          "subdomain": "memory",
          "response_value": 0
        }
      ]
    }
  ],
  "overall_score": 0,
  "highest_burden_domain": "",
  "pattern_flags": [],
  "generated_summary": "",
  "timestamp": ""
}

Production note: Final production implementation should include participant ID, study ID, site ID, visit window, consent status, IRB protocol reference, instrument version, data provenance, audit trail, and export controls.

Before Production Use

☐HIPAA-compliant hosting environment
☐Secure authentication and role-based access
☐Encrypted data storage
☐Audit logs
☐Consent and HIPAA authorization flow
☐IRB-approved protocol linkage
☐Study-specific visit schedule
☐Participant ID and site ID assignment
☐Version-controlled instrument library
☐Data dictionary
☐Export schema
☐Clinician/researcher review workflow
☐Validation plan
☐Adverse event and safety observation routing, if applicable
☐Privacy policy and terms update
☐No real patient data in demo mode