Category
Standard
Organisation
Type
Standard
Version
2
Access
Open
Status
Active
The HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report has 2 parts. Part 1: The Framework for Adverse Event Reporting, R2 has been published by ANSI as ANSI/HL7 V3 ICSRP1, R2-2012. Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2 has been approved by ANSI as ANSI/HL7 V3 ICSRP2, R2-2012.
The Individual Case Safety Report (ICSR) captures information about adverse events and product problems reported to public health, patient safety/quality improvement organisations or regulatory agencies. The ICSR message supports reporting from various sources such as consumers, hospitals, contract research organisations, clinicians or pharmaceutical product and medical device manufacturers.
The Individual Case Safety Report (ICSR) captures information about adverse events and product problems reported to public health, patient safety/quality improvement organisations or regulatory agencies. The ICSR message supports reporting from various sources such as consumers, hospitals, contract research organisations, clinicians or pharmaceutical product and medical device manufacturers.
Access HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2
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