PROTOCOL DEVIATION INTEGRITY · 0.2-DV1

Show every departure.
Keep every denominator.

Real deployments will depart from plan. Profile 0.2-DV1 makes every detected departure traceable, timely, independently reviewed, and incapable of quietly improving W by deleting environments, time, or endpoints.

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5DISCOVERY SOURCES

7INTEGRITY GATES

0SUPPRESSED DEVIATIONS

0ANALYTIC EXCLUSIONS

01 / EXECUTION INTEGRITY

Deviation is evidence.
Not an escape hatch.

A planned prospective change belongs in the amendment chain. An unplanned departure belongs in the deviation register. Neither can silently rewrite exposure or outcomes already observed.

01CAPTURE EVERYTHING

Reconcile candidates from telemetry, incidents, operations, participant reports, and independent audit.

02CLASSIFY BLIND

Determine importance without current-cohort outcomes or aggregate W.

03CORRECT FORWARD

Important deviations require root cause, containment, corrective action, and prevention.

04KEEP THE DENOMINATOR

A deviation never removes an activated environment, resident time, or a canonical terminal event.

02 / CLOSED RECONCILIATION

Every candidate
gets a disposition.

Source systems yield deviation candidates. Deduplicate them, bind each to one controlled record, and resolve every candidate before submission. Zero candidates may disappear between discovery and the public aggregate history.

RECONCILIATION IDENTITYU = ΣC_s − D

linked records = unique candidates; unresolved = 0

DEVIATION COUNT NEVER RANKS

03 / LOCAL REPRODUCTION

Rebuild the history.
Reject the shortcut.

The browser verifier checks discovery closure, unique source links, time order, preregistered reporting deadlines, importance and CAPA, required notifications, exact aggregates, and zero analytic manipulation.

LOCAL · ZERO UPLOADPROTOCOL DEVIATIONS 0.2-DV1 VERIFIER

DEVIATION RECONCILIATION MANIFEST

{
  "profile_version": "0.2-DV1",
  "target_certification": "WANTED_WILD",
  "protocol": {
    "inclusion_rule": "every_detected_or_reconciled_departure_from_the_frozen_protocol",
    "classification_rule": "important_if_participant_rights_safety_or_data_reliability_may_be_materially_affected",
    "outcome_blinding_rule": "classify_without_current_cohort_outcomes_or_aggregate_W",
    "analysis_rule": "retain_every_activated_environment_and_all_resident_time",
    "endpoint_rule": "deviation_labels_never_recode_terminal_events",
    "amendment_boundary": "planned_change_is_an_amendment_unplanned_departure_is_a_deviation",
    "deadline_rule": "use_preregistered_reporting_deadline_no_universal_threshold",
    "reporting_deadline_hours": 72
  },
  "study": {
    "study_id": "SYNTHETIC-STUDY-001",
    "preregistration_sha256": "b0123456789abcdef0123456789abcdef0123456789abcdef0123456789abcde",
    "claim_revision_id": "claim-r1",
    "first_benchmark_activity_at": "2025-12-15T00:00:00Z",
    "submission_at": "2026-08-28T18:00:00Z"
  },
  "reconciliation": {
    "telemetry_candidates": 1,
    "incident_candidates": 0,
    "operations_candidates": 1,
    "participant_report_candidates": 0,
    "audit_candidates": 0,
    "duplicate_candidates": 0,
    "unique_candidates": 2,
    "linked_records": 2,
    "unresolved_candidates": 0
  },
  "records": [
    {
      "deviation_id": "DV-001",
      "source_system": "telemetry_reconciliation",
      "source_record_sha256": "e10123456789abcdef0123456789abcdef0123456789abcdef0123456789abcd",
      "protocol_requirement_ref": "telemetry.upload_window",
      "preregistration_sha256": "b0123456789abcdef0123456789abcdef0123456789abcdef0123456789abcde",
      "category": "telemetry_data",
      "importance": "nonimportant",
      "importance_rationale": "The delayed upload preserved signed source events and did not affect safety, rights, endpoints, exposure, or analysis.",
      "scope": "environment",
      "affected_environment_ids": [
        "env-001"
      ],
      "occurred_at": "2026-02-01T02:00:00Z",
      "detected_at": "2026-02-01T03:00:00Z",
      "reported_at": "2026-02-01T04:00:00Z",
      "report_delay_hours": 1,
      "within_preregistered_deadline": true,
      "description": "A signed telemetry batch reached the evidence store after its preregistered upload window.",
      "root_cause": null,
      "containment": null,
      "corrective_action": null,
      "preventive_action": null,
      "independent_reviewed": true,
      "participant_notice_required": false,
      "participant_notice_completed": false,
      "safety_committee_notification_required": false,
      "safety_committee_notification_completed": false,
      "excluded_from_primary_analysis": false,
      "resident_seconds_deducted": 0,
      "endpoint_reclassified": false,
      "outcome_or_aggregate_w_used_for_classification": false,
      "unresolved": false,
      "claim_invalidated": false
    },
    {
      "deviation_id": "DV-002",
      "source_system": "operations_audit",
      "source_record_sha256": "e20123456789abcdef0123456789abcdef0123456789abcdef0123456789abcd",
      "protocol_requirement_ref": "operations.daily_readiness_check",
      "preregistration_sha256": "b0123456789abcdef0123456789abcdef0123456789abcdef0123456789abcde",
      "category": "intervention_operations",
      "importance": "important",
      "importance_rationale": "The missed readiness check could materially affect data reliability if not contained and independently reviewed.",
      "scope": "environment",
      "affected_environment_ids": [
        "env-001"
      ],
      "occurred_at": "2026-02-01T06:00:00Z",
      "detected_at": "2026-02-01T07:00:00Z",
      "reported_at": "2026-02-01T08:00:00Z",
      "report_delay_hours": 1,
      "within_preregistered_deadline": true,
      "description": "The operator completed one daily readiness check after the frozen operational window had closed.",
      "root_cause": "A scheduler migration omitted one readiness-check trigger from the production operations queue.",
      "containment": "The affected deployment was held in a safe non-service state until the missed check was completed.",
      "corrective_action": "The missing trigger was restored and the complete queue configuration was independently reconciled.",
      "preventive_action": "A signed daily comparison now checks the frozen readiness schedule against every production trigger.",
      "independent_reviewed": true,
      "participant_notice_required": false,
      "participant_notice_completed": false,
      "safety_committee_notification_required": false,
      "safety_committee_notification_completed": false,
      "excluded_from_primary_analysis": false,
      "resident_seconds_deducted": 0,
      "endpoint_reclassified": false,
      "outcome_or_aggregate_w_used_for_classification": false,
      "unresolved": false,
      "claim_invalidated": false
    }
  ],
  "claimed": {
    "cohort_environment_count": 24,
    "deviation_count": 2,
    "important_deviations": 1,
    "nonimportant_deviations": 1,
    "late_reports": 0,
    "unresolved_important_deviations": 0,
    "unresolved_discovery_candidates": 0,
    "suppressed_deviations": 0,
    "primary_analysis_exclusions": 0,
    "resident_seconds_deducted": 0,
    "endpoint_reclassifications": 0,
    "outcome_informed_classifications": 0,
    "invalidated_claims": 0
  },
  "evidence": {
    "controlled_register_uri": "https://example.org/wanted-protocol-deviations.json",
    "controlled_register_sha256": "e30123456789abcdef0123456789abcdef0123456789abcdef0123456789abcd",
    "reconciliation_report_uri": "https://example.org/wanted-deviation-reconciliation.json",
    "reconciliation_report_sha256": "e40123456789abcdef0123456789abcdef0123456789abcdef0123456789abcd",
    "capa_index_uri": "https://example.org/wanted-deviation-capa.json",
    "capa_index_sha256": "e50123456789abcdef0123456789abcdef0123456789abcdef0123456789abcd",
    "public_aggregate_history_uri": "https://example.org/wanted-deviation-history.json",
    "public_aggregate_history_sha256": "e60123456789abcdef0123456789abcdef0123456789abcdef0123456789abcd"
  },
  "assessor": {
    "name": "Synthetic Deviation Assessor",
    "organization": "Independent Example Assurance",
    "independent_of_sponsor": true,
    "attested": true,
    "signed_at": "2026-08-28T18:30:00Z"
  }
}

READY TO RECONCILE DEVIATIONS

Paste aggregate deviation records and evidence digests only. No participant data leaves this browser.

04 / DESIGN BASIS

Operational reality,
made auditable.

These primary sources inform the evidence topology. The FDA source is draft guidance; WANTED remains vendor-neutral and does not claim regulatory conformity.

ICH E6(R3)Document deviations, noncompliance, oversight, and corrective and preventive actions.PRIMARY SOURCE ↗FDA DRAFT GUIDANCEConsistent definitions, classification, documentation, and reporting for protocol deviations.PRIMARY SOURCE ↗CONSORT 2025A deviation label alone does not justify post-allocation exclusion; nature and reason remain visible.PRIMARY SOURCE ↗W3C PROV-ORepresent entities, activities, agents, and derivations in interoperable provenance records.PRIMARY SOURCE ↗

NO COMPLETE REGISTER, NO CERTIFICATION CLAIM

Deviations can be disclosed and corrected. They cannot be used to erase difficult exposure.

OPEN AUDIT PACK →

Show every departure.Keep every denominator.

Deviation is evidence.Not an escape hatch.

Every candidategets a disposition.

Rebuild the history.Reject the shortcut.

Operational reality,made auditable.

Show every departure.
Keep every denominator.

Deviation is evidence.
Not an escape hatch.

Every candidate
gets a disposition.

Rebuild the history.
Reject the shortcut.

Operational reality,
made auditable.