Medical Research / I+D scaffold

A complete program, not a fragment: it compiles as written. Copy it, rename the placeholder identifiers to your domain, and run axon check — the compiler will tell you what your renaming broke. An MCP client can also generate it through the axon.compose tool by naming the medic_research domain.

// AXON Medical Research / I+D scaffold — clinical research + trial
// management pattern (HIPAA + GxP + IRB).
//
// Differs from `healthcare.axon` (patient care) and `pharmatech.axon`
// (drug discovery): this scaffold targets CLINICAL RESEARCH — study
// participant management, adverse-event recording, IRB-supervised
// trial workflows, informed-consent tracking, trial-data audit
// chains. Persona is clinical-researcher; compliance is HIPAA + GxP
// + 21 CFR Part 11 + IRB approval.

// ── Regulated data types ──────────────────────────────────────────

type StudyParticipant compliance [HIPAA, GxP] {
    participant_id:   Text
    study_id:         Text
    enrolled_at:      Text
    consent_status:   Text
    arm:              Text
}

type AdverseEvent compliance [HIPAA, GxP] {
    event_id:             Text
    participant_id:       Text
    study_id:             Text
    // `severity` is a reserved AXON keyword (shield.severity:) — use
    // a non-keyword field name for type bodies.
    severity_class:       Text
    onset:                Text
    description:          Text
    causality_assessment: Text
}

type ProtocolDeviation compliance [GxP] {
    deviation_id:      Text
    study_id:          Text
    description:       Text
    impact:            Text
}

type EventReceipt {
    accepted_at:       Text
    reviewer_assigned: Text
}

type DeviationReceipt {
    accepted_at:       Text
    severity_class:    Text
    irb_notification:  Text
}

type RecordAERequest         { event: AdverseEvent }
type RecordDeviationRequest  { deviation: ProtocolDeviation }

// ── Identity + grounding ──────────────────────────────────────────

persona ClinicalResearcher {
    domain: ["clinical-research", "trial-management", "good-clinical-practice", "irb-protocol"]
    tone: precise
    confidence_threshold: 0.92
    cite_sources: true
}

context TrialReview {
    memory: persistent
    language: "en"
    depth: exhaustive
    max_tokens: 4096
    temperature: 0.1
}

anchor InformedConsentVerified {
    require: evidence_backed
    confidence_floor: 0.95
    unknown_response: "Cannot record without verified informed consent — routing to coordinator."
    on_violation: raise ConsentVerificationError
}

// ── Shields — HIPAA + GxP gates ───────────────────────────────────

shield TrialShield {
    scan:       [prompt_injection, pii_leak, data_exfil, hallucination]
    on_breach:  quarantine
    severity:   critical
    redact:     [participant_id]
    compliance: [HIPAA, GxP, SOC2]
}

// ── Flows ─────────────────────────────────────────────────────────

flow RecordAdverseEvent(event: AdverseEvent) -> FlowEnvelope<EventReceipt> {
    step Classify {
        given: event
        ask: "Classify severity per ICH-GCP standards; assess causality; cite the relevant protocol section."
        output: FlowEnvelope<EventReceipt>
    }
    return Classify.output
}

flow RecordProtocolDeviation(deviation: ProtocolDeviation) -> FlowEnvelope<DeviationReceipt> {
    step Assess {
        given: deviation
        ask: "Classify the deviation's impact; recommend IRB notification urgency per the v1.13.1 CFR 56 thresholds."
        output: FlowEnvelope<DeviationReceipt>
    }
    return Assess.output
}

// ── HTTP boundaries ───────────────────────────────────────────────

axonendpoint AdverseEventAPI {
    method:      post
    path:        "/v1/trials/{study_id}/adverse-events"
    body:        RecordAERequest
    execute:     RecordAdverseEvent
    output:      FlowEnvelope<EventReceipt>
    shield:      TrialShield
    backend:     auto
    compliance:  [HIPAA, GxP, SOC2]
    retries:     1
    timeout:     15s
    requires:    ["medic_research.trials.write"]
}

axonendpoint ProtocolDeviationAPI {
    method:      post
    path:        "/v1/trials/{study_id}/deviations"
    body:        RecordDeviationRequest
    execute:     RecordProtocolDeviation
    output:      FlowEnvelope<DeviationReceipt>
    shield:      TrialShield
    backend:     auto
    compliance:  [GxP, SOC2]
    retries:     1
    timeout:     15s
    requires:    ["medic_research.trials.write"]
}