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Normas DIN – AENOR
DIN EN ISO 27953-1:2012-09

DIN EN ISO 27953-1:2012-09

Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting (ISO 27953-1:2011); German and English version EN ISO 27953-1:2011, only on CD-ROM

Informatique de santé - Rapports de sécurité de cas individuel (ICSRs) en pharmacovigilance - Partie 1: Cadre pour rapporter un événement défavorable (ISO 27953-1:2011); Version allemande et anglaise EN ISO 27953-1:2011, seulement en CD-ROM

Medizinische Informatik - Pharmakovigilanz - Einzelfallbericht für unerwünschte Arzneimittelwirkungen - Teil 1: Grundstruktur für Berichte über unerwünschte Arzneimittelwirkungen (ISO 27953-1:2011); Deutsche und Englische Fassung EN ISO 27953-1:2011, nur auf CD-ROM

Fecha:
2012-09 /Active
Equivalencias internacionales:

EN ISO 27953-1 (2011-12)

ISO/HL7 27953-1 (2011-12)

Relación con otras normas DIN:
Resumen:
Part 1 of this standard seeks to establish an international framework for data exchange and information sharing by providing a common messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that may occur upon the administration or use of one or more products. Part 1 is based upon the HL7 Reference Information Model and can be extended or constrained to accommodate a variety of reporting requirements based upon EN ISO 27953-2 and other regional and international requirements summarized in the storyboard section of this ballot. It should be noted that Part 1 will be harmonized over time with other HL7 public health and patient safety incident reporting standards to help ensure messaging constructs and vocabulary are harmonized across the PORR domain. Furthermore, Part 1 of this standard does not govern or dictate reporting requirements for any product. The use cases (storyboards) described in this standard are for demonstration purposes only and are provided to help demonstrate the standard's scalability and interoperability across multiple stakeholders and product types. Future releases of this standard may be developed to include conformance profiles and vocabulary for all or a limited subset of the use cases. Note that the data elements that were found to be consistent across all use cases are summarized as Generic Transmission Use Case Data Elements in this part. These data elements should be considered as a generic set of data elements that can be applied to any reporting scenario. Specific reporting requirements within organizations or regions may use all or only a subset of these data elements. Note this standard does not specify a vocabulary subset for these data elements in this release.
Keywords:
Computer sciences, Data, Data exchange, Data processing, Data recording, Data types, Definitions, Drugs, EDI, Electronic Data Interchange, Frame structures, Health data file, Information processing, Information technology, Medical informatics, Medical sciences, Medicaments, Message interchanges, Messages, Models, Patient protection, Patients, Pharmaceuticals, Public health, Records (documents), Reports, Surveillance (approval)
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