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ZINOS
A Spanish hospital of pale stone and deep shade at first light, a row of plane trees; no people.

Run your trials inside your Spanish hospital.

How ZINOS fits AEMPS review, CEIm ethics opinions, and Spain's rules on research use of health data.

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Trial approval in Spain.

AEMPS authorises the trial, and one accredited research ethics committee (CEIm) gives the ethics opinion.

  1. Protocol and dossier
  2. Submission through CTIS
  3. AEMPS assessment
  4. Single CEIm opinion
  5. Site agreement
  6. Trial conduct

Spanish rules, and how ZINOS fits.

  • Pseudonymised research data: separation of keys configurable
  • Device investigations: AEMPS, CEIm, and site director
  • Decentralised elements guide, 2024: remote steps logged

Where the record sits in Spain.

With on-premise deployment, AEMPS and the CEIm 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
  • CEIm
  • AEMPS
  • Sponsor
  • Monitor

Spanish requirements, mapped to ZINOS.

RequirementRuleZINOS capability
Ethics opinion before startRoyal Decree 1090/2015Approval tracking in the site file
Pseudonymised research dataOrganic Law 3/2018, additional provision 17Configurable pseudonymisation, logged access
Device investigationsAEMPS authorisation and CEIm opinionVersioned, signed submission documents
25-year trial file retentionClinical Trials Regulation, Art. 58Configurable retention and archival
Each row states a design fact about ZINOS, not a compliance claim.
A Spanish hospital of pale stone and deep shade at first light, a row of plane trees; no people.

See ZINOS against Spanish rules.

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