DIN EN ISO 27953-2:2012-09
Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011); German and English version EN ISO 27953-2:2011, only on CD-ROM
| Fecha edición: |
2012-09-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | Part 2 of this standard is based upon EN ISO 27953-2 requirements for regulatory reporting for human pharmaceutical products. Part 2 seeks to create a framework for international regulatory reporting and information sharing by providing a common set of data elements and messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), infections and incidents that may occur upon the administration of one or more human pharmaceutical products to a patient, regardless of source and destination. The standard provides a structure where reports can be exchanged in a clear and unambiguous manner such that the nature of the case, the circumstances in which it arose, and particularly the identity of the medicinal product(s) in question, can be communicated with certainty. Requirements for this use case were initially based upon ICH and conformance includes parallel adoption of ISO vocabulary work items: Data Elements and Structures for the Exchange of Regulated Product Information for Drug Dictionaries (See prEN ISO 11615, 11616, 11238, 11239, and 11240) and Structures and Controlled Vocabularies for Laboratory Test Units for the Reporting of Laboratory Results (See EN ISO 11595). |
| Keywords: | Computer sciences|Data|Data communication|Data exchange|Data processing|Data recording|Data types|Definitions|Drugs|EDI|Electronic Data Interchange|Frame structures|Health data file|Human medicine|Information processing|Information technology|Medical informatics|Medical sciences|Medicaments|Message interchanges|Messages|Models|Patient protection|Patients|Pharmaceuticals|Public health|Records (documents)|Reports|Surveillance (approval) |
| ICS: | 35.240.80 - Aplicaciones de las tecnologías de la información en la sanidad |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 27953-2:2011 Idéntica ISO/HL7 27953-2:2011 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 27953-2:2009-07 |
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