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G.k.2.5 Investigational Product Blinded
User Guidance This data element is applicable only to ICSRs from clinical trials. The
ICH E2A guideline recommends that the case safety reports with blinded
therapy should not be reported. However, if it is important to exchange a
blinded case safety report during a clinical trial, this data element should
be used as follows: until the investigational product is un-blinded, the
status ‘blinded’ should be indicated by using ‘true’ in this data element.
When this data element is ‘true’, Section G.k.2 Drug Identification
should be populated with the characteristics of the investigational product.
When more than one investigational product is potentially suspect, each
suspect product should be represented in separate G.k blocks. After un-
blinding, if appropriate, ‘placebo’ should be reported in G.k.2.3.r as a
suspect drug.
Conformance Optional
Data Type Boolean
OID None
Value Allowed true
Business Rule(s)
The value for this data element should be set to ‘true’ for ICSRs from
clinical trials when the product status is still blinded at the time the ICSR
is created. Otherwise, this data element should not be transmitted.
G.k.3 Holder and Authorisation /Application Number of Drug
If the ICH M5 MPID is not available for the reported medicinal product, the name of the holder
should be provided along with the authorisation or application number in the country where the
drug was obtained when the case report is sent to that country. Pharmaceutical companies
should provide this information for their own suspect drug(s).
G.k.3.1 Authorisation /Application Number
User Guidance If MPID (G.k.2.1.1) is unavailable, This data element captures the
Authorisation or Application number of the medicinal product for the
country where it was obtained when the case report is sent to that country.
Pharmaceutical companies should provide this information at least for
their own suspect drug(s).
Conformance Optional
Data Type 35 AN
OID 2.16.840.1.113883.3.989.2.1.3.4
Value Allowed Free text
BusinessRule(s)
The following notation will be used to represent G.k.3.1:
id extension="authorisation /application number"
root="2.16.840.1.113883.3.989.2.1.3.4"/
The root indicates the namespace of G.k.3.1, the actual authorisation/
application number is populated at id extension.
ICH ICSR Implementation Guide 12 April 2013
-122-
G.k.2.5 Investigational Product Blinded
User Guidance This data element is applicable only to ICSRs from clinical trials. The
ICH E2A guideline recommends that the case safety reports with blinded
therapy should not be reported. However, if it is important to exchange a
blinded case safety report during a clinical trial, this data element should
be used as follows: until the investigational product is un-blinded, the
status ‘blinded’ should be indicated by using ‘true’ in this data element.
When this data element is ‘true’, Section G.k.2 Drug Identification
should be populated with the characteristics of the investigational product.
When more than one investigational product is potentially suspect, each
suspect product should be represented in separate G.k blocks. After un-
blinding, if appropriate, ‘placebo’ should be reported in G.k.2.3.r as a
suspect drug.
Conformance Optional
Data Type Boolean
OID None
Value Allowed true
Business Rule(s)
The value for this data element should be set to ‘true’ for ICSRs from
clinical trials when the product status is still blinded at the time the ICSR
is created. Otherwise, this data element should not be transmitted.
G.k.3 Holder and Authorisation /Application Number of Drug
If the ICH M5 MPID is not available for the reported medicinal product, the name of the holder
should be provided along with the authorisation or application number in the country where the
drug was obtained when the case report is sent to that country. Pharmaceutical companies
should provide this information for their own suspect drug(s).
G.k.3.1 Authorisation /Application Number
User Guidance If MPID (G.k.2.1.1) is unavailable, This data element captures the
Authorisation or Application number of the medicinal product for the
country where it was obtained when the case report is sent to that country.
Pharmaceutical companies should provide this information at least for
their own suspect drug(s).
Conformance Optional
Data Type 35 AN
OID 2.16.840.1.113883.3.989.2.1.3.4
Value Allowed Free text
BusinessRule(s)
The following notation will be used to represent G.k.3.1:
id extension="authorisation /application number"
root="2.16.840.1.113883.3.989.2.1.3.4"/
The root indicates the namespace of G.k.3.1, the actual authorisation/
application number is populated at id extension.