{
  "schemaVersion": 1,
  "datasetId": "i6eal.ki-studienmonitor-eu.v1",
  "dateModified": "2026-08-12",
  "materialFingerprint": "809dbcff8b1974de687649eab5afa93a5b3314f5e3a7492211bb493a414a97a5",
  "sourceFingerprint": "af3965a15574b11d08c3ab45daa8a4e3af91a18acc8f6975325295f3bad1d9d0",
  "sourcePolicy": {
    "officialOnly": true,
    "source": "Clinical Trials Information System (CTIS) public retrieve API",
    "sourceOperator": "European Medicines Agency",
    "allowedHost": "euclinicaltrials.eu",
    "identityRule": "Exact EUCT number from the reviewed 20-study registry; no fuzzy entity matching.",
    "evidenceRule": "Exact artificial intelligence, machine learning, deep learning or neural network phrase in an allowlisted public scientific field.",
    "privacyRule": "Only reviewed trial, application, country, status and exact evidence fields are retained. Raw records, sponsor/contact names, addresses, telephone numbers and email addresses are never written."
  },
  "claimBoundary": {
    "medicinalClinicalTrialsOnly": true,
    "publicationCorpus": false,
    "fundingCorpus": false,
    "efficacyInferred": false,
    "complianceInferred": false,
    "causalInferenceUsed": false
  },
  "methodology": {
    "selection": "Closed registry of 20 verified EUCT identifiers with exact AI-term evidence in reviewed CTIS public scientific fields.",
    "identity": "EUCT number only. Similar names, sponsors and titles are never merged.",
    "privacy": "The bootstrap sanitizes the in-memory CTIS response immediately. Raw records, contacts, addresses, telephone numbers and email addresses are never written.",
    "histories": "Application and country status history reproduces allowlisted CTIS public record fields. Collector observation events are kept separately.",
    "limits": "Presence in this dataset does not establish efficacy, safety, causality, regulatory compliance or a material role of AI in the intervention."
  }
}