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ZINOS
An Italian hospital cloister of warm stone at first light, arches and a quiet courtyard; no people.

Run your trials inside your Italian hospital.

How ZINOS fits AIFA review, Italy's territorial ethics committees, and the rules on research use of health data.

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Trial approval in Italy.

AIFA authorises the trial, and one of 40 territorial ethics committees, or a national committee, gives the opinion.

  1. Protocol and dossier
  2. Submission through CTIS
  3. AIFA assessment
  4. Territorial ethics committee
  5. Trial conduct

Italian rules, and how ZINOS fits.

  • Electronic consent, if the ethics committee approves: eICF with audit trail
  • Retrospective research: safeguards and a published impact assessment
  • Public-sector cloud qualification: on-premise deployment

Where the record sits in Italy.

With on-premise deployment, AIFA and the ethics committee receive what the rules require, and the trial record stays inside your hospital.

  • Hospital information system
  • Laboratory system
  • Imaging and pathology
  • Identity and access
  • Site operating system
  • Data hub
  • Local AI node
  • Audit trail
Scoped access
  • Ethics committee
  • AIFA
  • Sponsor
  • Monitor

Italian requirements, mapped to ZINOS.

RequirementRuleZINOS capability
Ethics opinion before startMinistry of Health decree, 26 January 2023Approval tracking in the site file
Electronic consentNational consent guidelines, v4, May 2026Tablet eICF with audit trail
Research without consentPrivacy Code, Art. 110; Garante, May 2024Configurable pseudonymisation, logged access
25-year trial file retentionClinical Trials Regulation, Art. 58Configurable retention and archival
Each row states a design fact about ZINOS, not a compliance claim.
An Italian hospital cloister of warm stone at first light, arches and a quiet courtyard; no people.

See ZINOS against Italian rules.

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