{
  "$schema": "https://json-schema.org/draft/2020-12/schema",
  "$id": "urn:nm-medical-psilocybin:raci:core-extended-data-set:2026-09-11",
  "title": "Core / Extended Data Set",
  "description": "Field-level schema recommended by the Research and Continuous Improvement Committee, New Mexico Medical Psilocybin Program. Revision 2026-09-11. Document created by Gregory Evans, gregory.l.evans@gmail.com.",
  "$comment": "Created by Gregory Evans (gregory.l.evans@gmail.com). Questions about this schema go to that address.",
  "info": {
    "version": "2026-09-11",
    "created_by": {
      "name": "Gregory Evans",
      "email": "gregory.l.evans@gmail.com",
      "workgroup": "RACI Data Reporting and Architecture, New Mexico Medical Psilocybin Program"
    },
    "contact": "gregory.l.evans@gmail.com",
    "tiers": {
      "Core": "The data set RACI recommends for every participant and every session. Compliance is the subset of Core the department requires.",
      "Extended": "Opt-in research data. Requires ongoing consent.",
      "Engagement": "Platform and continuity-of-care features. Beyond regulatory minimums."
    },
    "compliance": "true marks the subset of Core the department requires. The department sets that subset; Core extends beyond it."
  },
  "field_count": 136,
  "sections": [
    {
      "number": 1,
      "name": "Patient Demographics",
      "fields": [
        {
          "field": "Patient Identifier",
          "tier": "Core",
          "entered_by": "Patient",
          "timepoint": "Intake",
          "type_or_value_set": "not stated",
          "definition": "Anonymized unique ID.",
          "compliance": true,
          "section": 1
        },
        {
          "field": "Year of Birth",
          "tier": "Core",
          "entered_by": "Patient",
          "timepoint": "Intake",
          "type_or_value_set": "YYYY",
          "definition": "(YYYY) Age influences metabolism and cardiovascular risk.",
          "compliance": true,
          "section": 1
        },
        {
          "field": "Sex at Birth",
          "tier": "Core",
          "entered_by": "Patient",
          "timepoint": "Intake",
          "type_or_value_set": "Male / Female / Intersex",
          "definition": "(Male / Female / Intersex) Affects pharmacokinetics.",
          "compliance": true,
          "section": 1
        },
        {
          "field": "Gender Identity",
          "tier": "Core",
          "entered_by": "Patient",
          "timepoint": "Intake",
          "type_or_value_set": "CDC SOGI",
          "definition": "(CDC SOGI) LGBTQ+ access equity.",
          "compliance": true,
          "section": 1
        },
        {
          "field": "Race / Ethnicity",
          "tier": "Core",
          "entered_by": "Patient",
          "timepoint": "Intake",
          "type_or_value_set": "OMB",
          "definition": "(OMB) Equity tracking for Hispanic/Indigenous populations.",
          "compliance": true,
          "section": 1
        },
        {
          "field": "Tribal Affiliation",
          "tier": "Core",
          "entered_by": "Patient",
          "timepoint": "Intake",
          "type_or_value_set": "not stated",
          "definition": "Equity Fund utilization by Indigenous populations.",
          "compliance": false,
          "section": 1
        },
        {
          "field": "Household Income",
          "tier": "Core",
          "entered_by": "Patient",
          "timepoint": "Intake",
          "type_or_value_set": "% FPL",
          "definition": "(% FPL) Treatment Equity Fund subsidy eligibility.",
          "compliance": false,
          "section": 1
        },
        {
          "field": "Veteran Status",
          "tier": "Core",
          "entered_by": "Patient",
          "timepoint": "Intake",
          "type_or_value_set": "not stated",
          "definition": "PTSD outcome tracking in veterans.",
          "compliance": false,
          "section": 1
        },
        {
          "field": "Diagnosed Disability",
          "tier": "Core",
          "entered_by": "Patient",
          "timepoint": "Intake",
          "type_or_value_set": "No / Yes",
          "definition": "(No / Yes) ACLU compliance.",
          "compliance": false,
          "section": 1
        },
        {
          "field": "Zip Code",
          "tier": "Core",
          "entered_by": "Patient",
          "timepoint": "Intake",
          "type_or_value_set": "not stated",
          "definition": "Geographic access disparity (rural vs urban).",
          "compliance": true,
          "section": 1
        },
        {
          "field": "State of Residence",
          "tier": "Core",
          "entered_by": "Patient",
          "timepoint": "Intake",
          "type_or_value_set": "not stated",
          "definition": "Out-of-state jurisdictional reporting.",
          "compliance": true,
          "section": 1
        }
      ]
    },
    {
      "number": 2,
      "name": "Clinical Baseline",
      "fields": [
        {
          "field": "Patient Identifier",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Intake",
          "type_or_value_set": "not stated",
          "definition": "Linked to Demographics.",
          "compliance": true,
          "section": 2
        },
        {
          "field": "Engagement Identifier",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Intake",
          "type_or_value_set": "not stated",
          "definition": "Foreign key to Engagement. One baseline per engagement.",
          "compliance": true,
          "section": 2
        },
        {
          "field": "Medical readiness",
          "tier": "Core",
          "entered_by": "Medical Screener",
          "timepoint": "Intake",
          "type_or_value_set": "Imported value",
          "definition": "Medical readiness determination from the screening report. Imported from the screening system.",
          "compliance": false,
          "section": 2
        },
        {
          "field": "Primary Diagnosis",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Intake",
          "type_or_value_set": "ICD-10",
          "definition": "(ICD-10) e.g., F33.2 Major Depressive Disorder.",
          "compliance": true,
          "section": 2
        },
        {
          "field": "Diagnosis Duration",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Intake",
          "type_or_value_set": "not stated",
          "definition": "Acute distress vs chronic condition.",
          "compliance": false,
          "section": 2
        },
        {
          "field": "Treatment History",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Intake",
          "type_or_value_set": "Count of failed meds",
          "definition": "(Count of failed meds) Verifies treatment-resistant status.",
          "compliance": false,
          "section": 2
        },
        {
          "field": "Baseline Severity",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Intake",
          "type_or_value_set": "Scores in Clinical Outcomes at Follow-up Interval = Baseline",
          "definition": "Baseline scores are recorded in Clinical Outcomes with Follow-up Interval = Baseline, using the same instrument fields.",
          "compliance": false,
          "section": 2
        },
        {
          "field": "Screen-out decision",
          "tier": "Core",
          "entered_by": "Medical Screener",
          "timepoint": "Intake",
          "type_or_value_set": "proceeded / deferred / excluded / referred elsewhere / patient declined",
          "definition": "Outcome of screening. Rationale is recorded in Screen-out rationale.",
          "compliance": false,
          "section": 2
        },
        {
          "field": "Screen-out rationale",
          "tier": "Core",
          "entered_by": "Medical Screener",
          "timepoint": "Intake",
          "type_or_value_set": "Coded reasons plus free text",
          "definition": "Reason for a deferred, excluded, referred, or declined screening outcome. Coded reasons plus free text.",
          "compliance": false,
          "section": 2
        },
        {
          "field": "Referral From",
          "tier": "Extended",
          "entered_by": "Admin Clinician",
          "timepoint": "Intake",
          "type_or_value_set": "not stated",
          "definition": "Referral source (physician, self, etc.).",
          "compliance": false,
          "section": 2
        },
        {
          "field": "Health Assessment",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Intake",
          "type_or_value_set": "not stated",
          "definition": "Medical clearance for treatment.",
          "compliance": false,
          "section": 2
        },
        {
          "field": "Current medications",
          "tier": "Core",
          "entered_by": "Medical Screener",
          "timepoint": "Intake",
          "type_or_value_set": "RxNorm",
          "definition": "All current medications at intake. Interaction and washout relevance. Captured again per session under Session Logistics.",
          "compliance": false,
          "section": 2
        },
        {
          "field": "Polysubstance / Supplement / Peptide Use",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Intake",
          "type_or_value_set": "Structured list plus Other with text. Categories include SSRIs, SNRIs, GLP-1s, supplements, peptides, recreational substances",
          "definition": "[NEW] Recreational, supplement, and peptide use including GLP-1s. Interaction and safety screening.",
          "compliance": false,
          "section": 2
        },
        {
          "field": "Support Tier",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Intake",
          "type_or_value_set": "Tier 1 Standard Support / Tier 2 Enhanced Clinical Support / Tier 3 Specialist Supported Care / Tier 4 Not Appropriate for Participation at This Time",
          "definition": "[NEW] Clinical Support Framework tier assigned at evaluation, per the Patient Qualification and Safety Committee.",
          "compliance": false,
          "section": 2
        }
      ]
    },
    {
      "number": 3,
      "name": "Medicine Data (lot-level)",
      "fields": [
        {
          "field": "Product Lot #",
          "tier": "Core",
          "entered_by": "Licensed Grower",
          "timepoint": "Per lot, at testing",
          "type_or_value_set": "not stated",
          "definition": "Traceability for recalls, contamination, dosage.",
          "compliance": true,
          "section": 3
        },
        {
          "field": "Psilocybin",
          "tier": "Core",
          "entered_by": "Licensed Grower",
          "timepoint": "Per lot, at testing",
          "type_or_value_set": "mg/g",
          "definition": "(mg/g) Measured per gram.",
          "compliance": false,
          "section": 3
        },
        {
          "field": "Psilocin",
          "tier": "Core",
          "entered_by": "Licensed Grower",
          "timepoint": "Per lot, at testing",
          "type_or_value_set": "mg/g",
          "definition": "(mg/g) Measured per gram.",
          "compliance": false,
          "section": 3
        },
        {
          "field": "Baeocystin",
          "tier": "Core",
          "entered_by": "Licensed Grower",
          "timepoint": "Per lot, at testing",
          "type_or_value_set": "mg/g",
          "definition": "(mg/g) Minor alkaloid; required NM panel.",
          "compliance": false,
          "section": 3
        },
        {
          "field": "Norbaeocystin",
          "tier": "Core",
          "entered_by": "Licensed Grower",
          "timepoint": "Per lot, at testing",
          "type_or_value_set": "mg/g",
          "definition": "(mg/g) Minor alkaloid; required NM panel.",
          "compliance": false,
          "section": 3
        },
        {
          "field": "Aeruginascin",
          "tier": "Core",
          "entered_by": "Licensed Grower",
          "timepoint": "Per lot, at testing",
          "type_or_value_set": "mg/g",
          "definition": "(mg/g) Antagonist activity; safety-relevant.",
          "compliance": false,
          "section": 3
        },
        {
          "field": "Max Theoretical Psilocin (MTP)",
          "tier": "Extended",
          "entered_by": "Calculated",
          "timepoint": "Per lot, at testing",
          "type_or_value_set": "Calculated: MTP/g = Psilocin + (Psilocybin x 0.719)",
          "definition": "MTP/g = Psilocin + (Psilocybin x 0.719). Normalizes potency.",
          "compliance": false,
          "section": 3
        },
        {
          "field": "Available Psilocin Fraction (AFP)",
          "tier": "Extended",
          "entered_by": "Calculated",
          "timepoint": "Per lot, at testing",
          "type_or_value_set": "Calculated: AFP = Psilocin / MTP",
          "definition": "AFP = Psilocin / MTP.",
          "compliance": false,
          "section": 3
        },
        {
          "field": "Onset Category",
          "tier": "Extended",
          "entered_by": "Calculated",
          "timepoint": "Per lot, at testing",
          "type_or_value_set": "Calculated: Rapid (AFP >= 0.40), Balanced (0.21-0.39), Sustained (<= 0.20)",
          "definition": "Rapid (AFP >= 0.40), Balanced (0.21-0.39), Sustained (<= 0.20).",
          "compliance": false,
          "section": 3
        },
        {
          "field": "Species / Cultivar",
          "tier": "Extended",
          "entered_by": "Licensed Grower",
          "timepoint": "Per lot, at testing",
          "type_or_value_set": "not stated",
          "definition": "Links batch to chemotype/lineage; dose-response by cultivar.",
          "compliance": false,
          "section": 3
        },
        {
          "field": "Drug Checking / Potency Source",
          "tier": "Core",
          "entered_by": "Licensed Grower",
          "timepoint": "Per lot, at testing",
          "type_or_value_set": "Certificate of analysis property on the lot record",
          "definition": "[NEW] Potency verification is a property of the lot record, from the laboratory certificate of analysis.",
          "compliance": false,
          "section": 3
        }
      ]
    },
    {
      "number": 4,
      "name": "Engagement",
      "fields": [
        {
          "field": "Engagement Identifier",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Engagement open; updated on status change",
          "type_or_value_set": "not stated",
          "definition": "Parent key linking all sessions, entries, reviews.",
          "compliance": true,
          "section": 4
        },
        {
          "field": "Patient Identifier",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Engagement open; updated on status change",
          "type_or_value_set": "not stated",
          "definition": "Linked to Demographics.",
          "compliance": true,
          "section": 4
        },
        {
          "field": "Engagement Open Date",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Engagement open; updated on status change",
          "type_or_value_set": "YYYY-MM-DD",
          "definition": "(YYYY-MM-DD) Date initiated.",
          "compliance": false,
          "section": 4
        },
        {
          "field": "Engagement Status",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Engagement open; updated on status change",
          "type_or_value_set": "Active / Complete / Paused / Discontinued",
          "definition": "(Active / Complete / Paused / Discontinued).",
          "compliance": true,
          "section": 4
        },
        {
          "field": "Discontinuation Reason",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Engagement open; updated on status change",
          "type_or_value_set": "not stated",
          "definition": "Reason and responsible party if discontinued/paused.",
          "compliance": false,
          "section": 4
        },
        {
          "field": "Primary Prescriber ID",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Engagement open; updated on status change",
          "type_or_value_set": "not stated",
          "definition": "License ID of prescriber who set dose range.",
          "compliance": false,
          "section": 4
        },
        {
          "field": "Planned dosage range",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Engagement open; updated on status change",
          "type_or_value_set": "MTP low - MTP high",
          "definition": "Practitioner-recommended dosage range in the treatment plan (MTP low - MTP high).",
          "compliance": false,
          "section": 4
        }
      ]
    },
    {
      "number": 5,
      "name": "Session Registry",
      "fields": [
        {
          "field": "Session Identifier",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Each session",
          "type_or_value_set": "not stated",
          "definition": "Primary key for session-linked data.",
          "compliance": true,
          "section": 5
        },
        {
          "field": "Engagement Identifier",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Each session",
          "type_or_value_set": "not stated",
          "definition": "Foreign key to Engagement.",
          "compliance": true,
          "section": 5
        },
        {
          "field": "Patient Identifier",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Each session",
          "type_or_value_set": "not stated",
          "definition": "Linked to Demographics.",
          "compliance": true,
          "section": 5
        },
        {
          "field": "Session Type",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Each session",
          "type_or_value_set": "Preparatory / Dosing / Integration / Check-in / Emergency",
          "definition": "(Preparatory / Dosing / Integration / Check-in / Emergency).",
          "compliance": true,
          "section": 5
        },
        {
          "field": "Session Sequence",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Each session",
          "type_or_value_set": "Integer",
          "definition": "(Integer) Order within engagement.",
          "compliance": false,
          "section": 5
        },
        {
          "field": "Session Date",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Each session",
          "type_or_value_set": "YYYY-MM-DD",
          "definition": "(YYYY-MM-DD).",
          "compliance": true,
          "section": 5
        },
        {
          "field": "Provider ID",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Each session",
          "type_or_value_set": "not stated",
          "definition": "License ID of provider.",
          "compliance": true,
          "section": 5
        },
        {
          "field": "Provider Role",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Each session",
          "type_or_value_set": "Prescriber / Facilitator / Integration Therapist / Peer Support",
          "definition": "(Prescriber / Facilitator / Integration Therapist / Peer Support).",
          "compliance": false,
          "section": 5
        },
        {
          "field": "Session Notes",
          "tier": "Engagement",
          "entered_by": "Admin Clinician",
          "timepoint": "Each session",
          "type_or_value_set": "Free text",
          "definition": "Free-text session notes.",
          "compliance": false,
          "section": 5
        },
        {
          "field": "Session outcome status",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Each session",
          "type_or_value_set": "routine / challenging experience / adverse event / serious adverse event / follow-up pending / unable to determine",
          "definition": "Outcome classification of the session.",
          "compliance": false,
          "section": 5
        },
        {
          "field": "Linked Dosing Session ID",
          "tier": "Extended",
          "entered_by": "Admin Clinician",
          "timepoint": "Each session",
          "type_or_value_set": "not stated",
          "definition": "For prep/integration sessions, references the dosing session.",
          "compliance": false,
          "section": 5
        }
      ]
    },
    {
      "number": 6,
      "name": "Session Logistics",
      "fields": [
        {
          "field": "Session Identifier",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "not stated",
          "definition": "Foreign key to Session Registry.",
          "compliance": true,
          "section": 6
        },
        {
          "field": "Product Lot #",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "not stated",
          "definition": "Foreign key to Medicine Data. Lot administered in this session.",
          "compliance": true,
          "section": 6
        },
        {
          "field": "Facilitator License",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "not stated",
          "definition": "Links outcomes to provider for QI.",
          "compliance": true,
          "section": 6
        },
        {
          "field": "Concomitant Meds (incl. SSRIs/SNRIs)",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "RxNorm",
          "definition": "Per-session medications, including SSRIs and SNRIs.",
          "compliance": false,
          "section": 6
        },
        {
          "field": "Washout Compliance",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "Yes / No / N/A",
          "definition": "(Yes / No / N/A) Pre-session washout protocol.",
          "compliance": false,
          "section": 6
        },
        {
          "field": "Dosage",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "Number (grams)",
          "definition": "(Number) Weight in grams administered.",
          "compliance": true,
          "section": 6
        },
        {
          "field": "Calculated MTP Dose",
          "tier": "Core",
          "entered_by": "Calculated",
          "timepoint": "Dosing session",
          "type_or_value_set": "Calculated: Dosage weight x MTP/g",
          "definition": "Dosage weight x MTP/g. Actual psilocin-equivalent.",
          "compliance": false,
          "section": 6
        },
        {
          "field": "Dosage Form",
          "tier": "Extended",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "powder, whole, capsule, troche",
          "definition": "(powder, whole, capsule, troche) Delivery efficacy.",
          "compliance": false,
          "section": 6
        },
        {
          "field": "Route of administration",
          "tier": "Extended",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "Dropdown: chew / tea / lemon tek / other",
          "definition": "Route of administration. Other is recorded in Route of administration, other.",
          "compliance": false,
          "section": 6
        },
        {
          "field": "Route of administration, other",
          "tier": "Extended",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "Free text",
          "definition": "Route of administration when not on the list.",
          "compliance": false,
          "section": 6
        },
        {
          "field": "Admin Mode",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "Individual / Dyad / Group",
          "definition": "(Individual / Dyad / Group) Cost and safety.",
          "compliance": false,
          "section": 6
        },
        {
          "field": "Setting Type",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "Clinic / Home / Retreat Center",
          "definition": "(Clinic / Home / Retreat Center) Safety profile.",
          "compliance": false,
          "section": 6
        },
        {
          "field": "Prep Time",
          "tier": "Extended",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "Minutes",
          "definition": "(Minutes) Facilitator prep time.",
          "compliance": false,
          "section": 6
        },
        {
          "field": "Time of Admin",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "HH:MM",
          "definition": "(HH:MM) Exact ingestion time.",
          "compliance": false,
          "section": 6
        },
        {
          "field": "Time of First Onset",
          "tier": "Extended",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "HH:MM",
          "definition": "(HH:MM) First perceptual change.",
          "compliance": false,
          "section": 6
        },
        {
          "field": "Time of Peak",
          "tier": "Extended",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "HH:MM",
          "definition": "(HH:MM) Maximum intensity.",
          "compliance": false,
          "section": 6
        },
        {
          "field": "Time of Resolution",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "Dosing session",
          "type_or_value_set": "HH:MM",
          "definition": "(HH:MM) Return to functional baseline / discharge-ready.",
          "compliance": false,
          "section": 6
        },
        {
          "field": "Integration Methods / Practices Used",
          "tier": "Extended",
          "entered_by": "Admin Clinician",
          "timepoint": "Integration sessions",
          "type_or_value_set": "Dropdown: fixed modality list, plus Other with short text",
          "definition": "Integration modality used in the session. Fixed list maintained in committee guidance; Other with short text.",
          "compliance": false,
          "section": 6
        }
      ]
    },
    {
      "number": 7,
      "name": "Challenging Events / Adverse Events",
      "fields": [
        {
          "field": "Event Identifier",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "At event; updated at follow-up",
          "type_or_value_set": "not stated",
          "definition": "Primary key for the event record.",
          "compliance": false,
          "section": 7
        },
        {
          "field": "Session Identifier",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "At event; updated at follow-up",
          "type_or_value_set": "not stated",
          "definition": "Foreign key to Session Registry.",
          "compliance": true,
          "section": 7
        },
        {
          "field": "Product Lot # (AE linkage)",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "At event; updated at follow-up",
          "type_or_value_set": "not stated",
          "definition": "Product lot carried into the event record.",
          "compliance": false,
          "section": 7
        },
        {
          "field": "Harm Reduction / QI Tier",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "At event; updated at follow-up",
          "type_or_value_set": "Tier 1 / Tier 2 / Tier 3 / Tier 4",
          "definition": "Event tier per the Harm Reduction / QI Framework. Separate from CTCAE severity.",
          "compliance": true,
          "section": 7
        },
        {
          "field": "Event class",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "At event; updated at follow-up",
          "type_or_value_set": "Medical / Psychiatric / Safety and conduct",
          "definition": "Tier 4 subdivision from the framework, applied to every tier.",
          "compliance": true,
          "section": 7
        },
        {
          "field": "Event subtype",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "At event; updated at follow-up",
          "type_or_value_set": "medical / psychiatric / behavioral / safety incident / conduct or ethics violation / medication or administration error / cultural or spiritual mismatch / product or lot safety signal",
          "definition": "Finer classification of the event.",
          "compliance": false,
          "section": 7
        },
        {
          "field": "Participant direct report source",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "At event; updated at follow-up",
          "type_or_value_set": "facilitator / DOH direct / portal / follow-up session / post-session survey / caregiver or third party",
          "definition": "Channel through which the event was reported.",
          "compliance": false,
          "section": 7
        },
        {
          "field": "Event Description",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "At event; updated at follow-up",
          "type_or_value_set": "Narrative",
          "definition": "Narrative of the event.",
          "compliance": false,
          "section": 7
        },
        {
          "field": "Severity",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "At event; updated at follow-up",
          "type_or_value_set": "CTCAE v6.0 (Grades 1-5)",
          "definition": "CTCAE v6.0 (Grades 1-5).",
          "compliance": true,
          "section": 7
        },
        {
          "field": "Intervention",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "At event; updated at follow-up",
          "type_or_value_set": "Verbal / Rescue Meds / EMS",
          "definition": "(Verbal / Rescue Meds / EMS) Service burden.",
          "compliance": false,
          "section": 7
        },
        {
          "field": "Suicidality",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "At event; updated at follow-up",
          "type_or_value_set": "C-SSRS Score",
          "definition": "(C-SSRS Score) Treatment-emergent risk.",
          "compliance": false,
          "section": 7
        },
        {
          "field": "Duration of AE",
          "tier": "Core",
          "entered_by": "Admin Clinician",
          "timepoint": "At event; updated at follow-up",
          "type_or_value_set": "Minutes/Hours",
          "definition": "(Minutes/Hours) Transient vs persistent.",
          "compliance": false,
          "section": 7
        },
        {
          "field": "AE Domain (Palitsky framework)",
          "tier": "Extended",
          "entered_by": "Admin Clinician",
          "timepoint": "At event; updated at follow-up",
          "type_or_value_set": "not stated",
          "definition": "[NEW] Map to Palitsky's 54-item framework: pharmacological, psycho-spiritual, psychotherapy-related, sociocultural. Referenced from the Palitsky framework.",
          "compliance": false,
          "section": 7
        }
      ]
    },
    {
      "number": 8,
      "name": "Clinical Outcomes",
      "fields": [
        {
          "field": "Outcome Record Identifier",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "not stated",
          "definition": "Primary key for the outcome record.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Engagement Identifier",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "not stated",
          "definition": "Foreign key to Engagement.",
          "compliance": true,
          "section": 8
        },
        {
          "field": "Patient Identifier",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "not stated",
          "definition": "Linked to Demographics.",
          "compliance": true,
          "section": 8
        },
        {
          "field": "Session Identifier",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "not stated",
          "definition": "Foreign key to Session Registry. Acute-experience rows only.",
          "compliance": true,
          "section": 8
        },
        {
          "field": "Date of Follow-up",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "YYYY-MM-DD",
          "definition": "(YYYY-MM-DD).",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Follow-up Interval",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "Baseline / 24hr / 4wk / 3mo / 6mo",
          "definition": "(Baseline / 24hr / 4wk / 3mo / 6mo).",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Setting Type",
          "tier": "Extended",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "Clinic / Home / Retreat / Virtual",
          "definition": "(Clinic / Home / Retreat / Virtual).",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Session Modality",
          "tier": "Extended",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "not stated",
          "definition": "Therapeutic approaches in follow-up integration.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Mystical Experience Score",
          "tier": "Extended",
          "entered_by": "Integration Clinician",
          "timepoint": "After dosing session",
          "type_or_value_set": "Score; instrument per Mystical Experience instrument used",
          "definition": "Characterization of the acute session experience: meaningful/mystical experience (no baseline). Instrument recorded in Mystical Experience instrument used.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Mystical Experience instrument used",
          "tier": "Extended",
          "entered_by": "Integration Clinician",
          "timepoint": "After dosing session",
          "type_or_value_set": "MEQ-30 / MEQ-4",
          "definition": "Instrument used for the Mystical Experience Score. Preferred instrument MEQ-30; accepted alternative MEQ-4.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Challenging Experience Score",
          "tier": "Extended",
          "entered_by": "Integration Clinician",
          "timepoint": "After dosing session",
          "type_or_value_set": "Score; instrument per Challenging Experience instrument used",
          "definition": "Characterization of the acute session experience: challenging experience (no baseline). Instrument recorded in Challenging Experience instrument used.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Challenging Experience instrument used",
          "tier": "Extended",
          "entered_by": "Integration Clinician",
          "timepoint": "After dosing session",
          "type_or_value_set": "CEQ-26 / CEQ-7",
          "definition": "Instrument used for the Challenging Experience Score. Preferred instrument CEQ-26; accepted alternative CEQ-7.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Ego Dissolution Score",
          "tier": "Extended",
          "entered_by": "Integration Clinician",
          "timepoint": "After dosing session",
          "type_or_value_set": "Score; instrument per Ego Dissolution instrument used",
          "definition": "EDI. Instrument recorded in Ego Dissolution instrument used.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Ego Dissolution instrument used",
          "tier": "Extended",
          "entered_by": "Integration Clinician",
          "timepoint": "After dosing session",
          "type_or_value_set": "EDI",
          "definition": "Instrument used for the Ego Dissolution Score. Preferred instrument EDI; no accepted alternative listed.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Depression Score",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "Score; instrument per Depression instrument used",
          "definition": "Depression symptom severity score at baseline and follow-up. Instrument recorded in Depression instrument used. Primary TRD endpoint.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Depression instrument used",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "PHQ-9 / MADRS / QIDS-SR16 / GRID-HAMD",
          "definition": "Instrument used for the Depression Score. Preferred instrument PHQ-9; accepted alternatives MADRS, QIDS-SR16, GRID-HAMD.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Depression administration role",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "patient self-report / facilitator / licensed provider / integration clinician / trained rater",
          "definition": "Role of the person who administered the depression instrument.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "PTSD Score",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "Score; instrument per PTSD instrument used",
          "definition": "PTSD symptom severity score at baseline and follow-up (where PTSD is the qualifying condition). Instrument recorded in PTSD instrument used. Primary PTSD endpoint.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "PTSD instrument used",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "PCL-5 / CAPS-5",
          "definition": "Instrument used for the PTSD Score. Preferred instrument PCL-5; accepted alternative CAPS-5.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "PTSD administration role",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "patient self-report / facilitator / licensed provider / integration clinician / trained rater",
          "definition": "Role of the person who administered the PTSD instrument.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Anxiety Score",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "Score; instrument per Anxiety instrument used",
          "definition": "Anxiety severity score at baseline and follow-up. Instrument recorded in Anxiety instrument used.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Anxiety instrument used",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "OASIS / GAD-7 / STAI",
          "definition": "Instrument used for the Anxiety Score. Preferred instrument OASIS; accepted alternatives GAD-7, STAI.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Substance Use",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "Score; instrument per Substance Use instrument used",
          "definition": "Substance use, risk, and protective recovery factors at treatment baseline and follow-up once accepted into the SUD pathway. Instrument recorded in Substance Use instrument used.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Substance Use instrument used",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "BAM / TLFB",
          "definition": "Instrument used for Substance Use. Preferred instrument BAM (Brief Addiction Monitor); accepted alternative TLFB.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Substance Use administration role",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "patient self-report / facilitator / licensed provider / integration clinician / trained rater",
          "definition": "Role of the person who administered the substance use instrument.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Wellbeing Score",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "Score; instrument per Wellbeing instrument used",
          "definition": "Positive wellbeing score at baseline and follow-up. Instrument recorded in Wellbeing instrument used.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Wellbeing instrument used",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "WHO-5 / SWLS",
          "definition": "Instrument used for the Wellbeing Score. Preferred instrument WHO-5; accepted alternative SWLS.",
          "compliance": false,
          "section": 8
        },
        {
          "field": "Therapeutic Alliance (risk factor)",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Baseline / 24hr / 4wk / 3mo / 6mo per Follow-up Interval",
          "type_or_value_set": "WAI-SR, 12 items, 1 to 5 scale, patient and therapist versions",
          "definition": "Therapeutic alliance rated at each follow-up interval as a risk factor. Preferred instrument WAI-SR.",
          "compliance": false,
          "section": 8
        }
      ]
    },
    {
      "number": 9,
      "name": "Patient Portal (Engagement layer)",
      "fields": [
        {
          "field": "Entry Identifier",
          "tier": "Engagement",
          "entered_by": "Patient",
          "timepoint": "Continuous, participant-initiated",
          "type_or_value_set": "not stated",
          "definition": "Primary key for the portal entry.",
          "compliance": false,
          "section": 9
        },
        {
          "field": "Patient Identifier",
          "tier": "Engagement",
          "entered_by": "Patient",
          "timepoint": "Continuous, participant-initiated",
          "type_or_value_set": "not stated",
          "definition": "Linked to Demographics.",
          "compliance": false,
          "section": 9
        },
        {
          "field": "Engagement Identifier",
          "tier": "Engagement",
          "entered_by": "Patient",
          "timepoint": "Continuous, participant-initiated",
          "type_or_value_set": "not stated",
          "definition": "Foreign key to Engagement.",
          "compliance": false,
          "section": 9
        },
        {
          "field": "Entry Timestamp",
          "tier": "Engagement",
          "entered_by": "Patient",
          "timepoint": "Continuous, participant-initiated",
          "type_or_value_set": "YYYY-MM-DD HH:MM",
          "definition": "(YYYY-MM-DD HH:MM).",
          "compliance": false,
          "section": 9
        },
        {
          "field": "Entry Type",
          "tier": "Engagement",
          "entered_by": "Patient",
          "timepoint": "Continuous, participant-initiated",
          "type_or_value_set": "Journal / Check-in Response",
          "definition": "(Journal / Check-in Response).",
          "compliance": false,
          "section": 9
        },
        {
          "field": "Journal Text",
          "tier": "Engagement",
          "entered_by": "Patient",
          "timepoint": "Continuous, participant-initiated",
          "type_or_value_set": "Free text",
          "definition": "Free-text integration narrative.",
          "compliance": false,
          "section": 9
        },
        {
          "field": "Prompted Question",
          "tier": "Engagement",
          "entered_by": "Patient",
          "timepoint": "Continuous, participant-initiated",
          "type_or_value_set": "not stated",
          "definition": "Question the app sent.",
          "compliance": false,
          "section": 9
        },
        {
          "field": "Check-in Response Text",
          "tier": "Engagement",
          "entered_by": "Patient",
          "timepoint": "Continuous, participant-initiated",
          "type_or_value_set": "not stated",
          "definition": "Response to prompted check-in.",
          "compliance": false,
          "section": 9
        },
        {
          "field": "Distress Flag (self-reported)",
          "tier": "Core",
          "entered_by": "Patient",
          "timepoint": "Continuous, participant-initiated",
          "type_or_value_set": "None / Mild / Moderate / Severe",
          "definition": "(None / Mild / Moderate / Severe) Compliance-relevant trigger.",
          "compliance": false,
          "section": 9
        }
      ]
    },
    {
      "number": 10,
      "name": "Clinician Review + Feedback Loop",
      "fields": [
        {
          "field": "Review Identifier",
          "tier": "Engagement",
          "entered_by": "Integration Clinician",
          "timepoint": "Each review",
          "type_or_value_set": "not stated",
          "definition": "Unique ID for the review event.",
          "compliance": false,
          "section": 10
        },
        {
          "field": "Patient Identifier",
          "tier": "Engagement",
          "entered_by": "Integration Clinician",
          "timepoint": "Each review",
          "type_or_value_set": "not stated",
          "definition": "Linked to Demographics.",
          "compliance": false,
          "section": 10
        },
        {
          "field": "Engagement Identifier",
          "tier": "Engagement",
          "entered_by": "Integration Clinician",
          "timepoint": "Each review",
          "type_or_value_set": "not stated",
          "definition": "Foreign key to Engagement.",
          "compliance": false,
          "section": 10
        },
        {
          "field": "Entry Identifier",
          "tier": "Engagement",
          "entered_by": "Integration Clinician",
          "timepoint": "Each review",
          "type_or_value_set": "not stated",
          "definition": "Foreign key to the Patient Portal entry reviewed.",
          "compliance": false,
          "section": 10
        },
        {
          "field": "Review Timestamp",
          "tier": "Engagement",
          "entered_by": "Integration Clinician",
          "timepoint": "Each review",
          "type_or_value_set": "Timestamp",
          "definition": "When review completed.",
          "compliance": false,
          "section": 10
        },
        {
          "field": "Reviewing Clinician ID",
          "tier": "Engagement",
          "entered_by": "Integration Clinician",
          "timepoint": "Each review",
          "type_or_value_set": "not stated",
          "definition": "License/ID of reviewer.",
          "compliance": false,
          "section": 10
        },
        {
          "field": "Clinical Assessment",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Each review",
          "type_or_value_set": "No Concern / Monitor / Outreach Warranted / Escalate",
          "definition": "(No Concern / Monitor / Outreach Warranted / Escalate).",
          "compliance": false,
          "section": 10
        },
        {
          "field": "Action Taken",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Each review",
          "type_or_value_set": "No Action / Scheduled Follow-up / Outreach Call / Emergency Referral",
          "definition": "(No Action / Scheduled Follow-up / Outreach Call / Emergency Referral).",
          "compliance": false,
          "section": 10
        },
        {
          "field": "Review Notes",
          "tier": "Engagement",
          "entered_by": "Integration Clinician",
          "timepoint": "Each review",
          "type_or_value_set": "Free text",
          "definition": "Free-text observations/rationale.",
          "compliance": false,
          "section": 10
        },
        {
          "field": "Suicidality Flag",
          "tier": "Core",
          "entered_by": "Integration Clinician",
          "timepoint": "Each review",
          "type_or_value_set": "Yes / No",
          "definition": "(Yes / No) Triggered C-SSRS/suicidality protocol?",
          "compliance": false,
          "section": 10
        },
        {
          "field": "Signal-to-Response Trigger",
          "tier": "Core",
          "entered_by": "Reviewer",
          "timepoint": "Each review",
          "type_or_value_set": "Distress Flag = Severe / Suicidality Flag = Yes / Clinical Assessment = Escalate / Harm Reduction Tier = 3 or 4 / Session outcome status = adverse event or serious adverse event",
          "definition": "[NEW] Which signal opened this review and made a response required. Recorded per review.",
          "compliance": false,
          "section": 10
        },
        {
          "field": "Review Cadence",
          "tier": "Core",
          "entered_by": "Reviewer",
          "timepoint": "Each review",
          "type_or_value_set": "Prompt (Tier 4 within 24 to 48 hours; Tier 3 within 5 business days) / Routine monthly / Quarterly trend",
          "definition": "[NEW] Review type. Prompt windows follow the Harm Reduction / QI Framework reporting timelines.",
          "compliance": false,
          "section": 10
        },
        {
          "field": "Response Owner",
          "tier": "Core",
          "entered_by": "Reviewer",
          "timepoint": "Each review",
          "type_or_value_set": "Reviewing clinician / Facilitator / Prescriber / DOH",
          "definition": "[NEW] Role that owns the response once a trigger fires. Recorded per review.",
          "compliance": false,
          "section": 10
        },
        {
          "field": "Response Protocol / Outcome",
          "tier": "Core",
          "entered_by": "Reviewer",
          "timepoint": "Each review",
          "type_or_value_set": "Resolved / Ongoing / Referred out / No response needed; plus date closed",
          "definition": "[NEW] Outcome of Action Taken and the date the review closed. Closes the loop.",
          "compliance": false,
          "section": 10
        }
      ]
    }
  ],
  "_provenance": {
    "document_created_by": "Gregory Evans",
    "contact": "gregory.l.evans@gmail.com",
    "revision": "2026-09-11"
  }
}