AdverseEventReporting / ProductRole — ProductRole
Active
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FHIR: 0 resource(s),
0 attribute(s) mapped
Qualified: AdverseEventReporting::ProductRole
This class provides information on the medical product(s) (i.e., medical device or drug) that is either suspected to have caused an adverse event, or that was in use at the time of the adverse event and which may or may not have contributed to the event. Note that this class is used to navigate from the Case Safety Report to observations about the drug or device, which in turn point to the drug and device classes.
"The characterisation of the drug role as provided by the primary reporter or, if this information is missing, by the sender. All spontaneous reports should have at least one suspect drug...." - ICH E2B(R3), G.k.1.
Attributes / الخصائص
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No attributes yet.
FHIR Mapping (MOH → FHIR) / مواءمة FHIR
No FHIR resource mapping for this class.
Mappings (MOH → Models) / المواءمات
No benchmark mappings for this class.
Consumer Mappings / مواءمة المستفيدين
No consumer mappings for this class.