153
ICH ICSR Implementation Guide 12 April 2013
-154-
PORR_MT049016UV
User
Guidance
‘The Human Pharmaceuticals Base Model RMIM is designed to support a report
about an investigation into an adverse event(s) or reaction(s) suffered by a
person that experienced an intervention (substance administration or procedure)
within a therapeutic context. The suspect event may or may not have a causal
relationship with the intervention and the model supports events suffered by
associated persons e.g. mother/child or siblings‘ (ISO/HL7 27953-2).
PORR_MT049023UV
User
Guidance
‘The A_HumanPharmaceuticalsPRRI RMIM captures information about the acts
that describe how a product was used by an investigative subject. The
information includes use of a product (substance administration and device
procedures) and any associated clinical or laboratory information directly
related to the product's use at a particular point in time, e.g. related to an
adverse event, or as part of a subject's medical history. The model also supports
other patient care or healthcare-related processes such as actions taken to
mitigate or reduce harm’ (ISO/HL7 27953-2).
ICSR Common Product Model CMET
POCP_MT010200UV
User
Guidance
This schema is derived from ‘E_ProductKind CMET’ which supports specified
drug information.
For ICH ICSR messages, this schema defines drug information such as
identifiers (e.g. Medicinal Product Identifier (MPID) (G.k.2.1.1b) and
Pharmaceutical Product Identifier (PhPID) (G.k.2.1.2b)) and the Pharmaceutical
Dose Form (G.k.4.r.9).
POCP_MT020200UV
User
Guidance
This schema is derived from ‘R_ProductReportable CMET’ which supports
information of drugs in reports and drugs for administration.
For ICH ICSR messages, this schema defines the Batch /Lot Number
(G.k.4.r.7).
POCP_MT030100UV
User
Guidance
This schema is derived from ‘R_ProductRelatedAssignedEntity CMET’:
‘A combination of a person and/or organisation involved in the product life
cycle in some way (e.g. creation and review of a product labeling document,
performing a testing activity)‘ (ISO/HL7 27953-2).
For ICH ICSR messages, this schema defines the Identification of the Country
Where the Drug Was Obtained (G.k.2.4).
ICH ICSR Implementation Guide 12 April 2013
-154-
PORR_MT049016UV
User
Guidance
‘The Human Pharmaceuticals Base Model RMIM is designed to support a report
about an investigation into an adverse event(s) or reaction(s) suffered by a
person that experienced an intervention (substance administration or procedure)
within a therapeutic context. The suspect event may or may not have a causal
relationship with the intervention and the model supports events suffered by
associated persons e.g. mother/child or siblings‘ (ISO/HL7 27953-2).
PORR_MT049023UV
User
Guidance
‘The A_HumanPharmaceuticalsPRRI RMIM captures information about the acts
that describe how a product was used by an investigative subject. The
information includes use of a product (substance administration and device
procedures) and any associated clinical or laboratory information directly
related to the product's use at a particular point in time, e.g. related to an
adverse event, or as part of a subject's medical history. The model also supports
other patient care or healthcare-related processes such as actions taken to
mitigate or reduce harm’ (ISO/HL7 27953-2).
ICSR Common Product Model CMET
POCP_MT010200UV
User
Guidance
This schema is derived from ‘E_ProductKind CMET’ which supports specified
drug information.
For ICH ICSR messages, this schema defines drug information such as
identifiers (e.g. Medicinal Product Identifier (MPID) (G.k.2.1.1b) and
Pharmaceutical Product Identifier (PhPID) (G.k.2.1.2b)) and the Pharmaceutical
Dose Form (G.k.4.r.9).
POCP_MT020200UV
User
Guidance
This schema is derived from ‘R_ProductReportable CMET’ which supports
information of drugs in reports and drugs for administration.
For ICH ICSR messages, this schema defines the Batch /Lot Number
(G.k.4.r.7).
POCP_MT030100UV
User
Guidance
This schema is derived from ‘R_ProductRelatedAssignedEntity CMET’:
‘A combination of a person and/or organisation involved in the product life
cycle in some way (e.g. creation and review of a product labeling document,
performing a testing activity)‘ (ISO/HL7 27953-2).
For ICH ICSR messages, this schema defines the Identification of the Country
Where the Drug Was Obtained (G.k.2.4).