ISO-27953-1 › Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting
The following bibliographic material is provided to assist you with your purchasing decision:
ISO 27953-1:2011 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 can occur upon the administration or use of one or more products.
The messaging format is based upon the HL7 Reference Information Model (RIM) and can be extended or constrained to accommodate a variety of reporting use cases. ISO 27953-1:2011 will be harmonized over time with other HL7 public health and patient safety reporting standards to help ensure that messaging constructs and vocabulary are harmonized in the HL7 Public Heath and Regulatory Reporting domains.
The data elements used in ISO 27953-1:2011 were identified as consistent across many of the use cases and can be applied to a variety of reporting scenarios. Specific reporting requirements within organizations or regions might vary.
To find similar documents by classification:
35.240.80 (IT applications in health care technology Including computer tomography)
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ISO/IEC-13211-1Information technology - Programming languages - Prolog - Part 1: General core
ISO/IEC-16022
Information technology - Automatic identification and data capture techniques - Data Matrix bar code symbology specification
IEC-60529
Degrees of protection provided by enclosures (IP Code)
Document Number
ISO/HL7 27953-1:2011
Revision Level
1ST EDITION REPRINT
Status
Current
Publication Date
Oct. 15, 2012
Committee Number
ISO/TC 215