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G.k.7.r Indication for Use in Case (repeat as necessary)
G.k.7.r.1 Indication as Reported by the Primary Source
User Guidance This data element captures the original reporter's words and /or short
phrases used to describe the indication for drug use in an English
translation for international transmission. ‘Not specified’ or ‘Unknown’
can be used if the source has not provided or does not know the
information, respectively.
Conformance Optional
Data Type 250AN
OID None
Value Allowed Free text
nullFlavor: ASKU, NASK, UNK
Business Rule(s)
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
Please use nullFlavor with original text attribute in XML instance (See
Appendix I (D) the Reference Instance).
G.k.7.r.2a MedDRA Version for Indication
User Guidance This data element provides the MedDRA version for G.k.7.r.2b
Conformance Optional, but required if G.k.7.r.2b is populated.
Data Type 4AN
OID None
Value Allowed Numeric and ‘. ‘(dot)
Business Rule(s)
Only 1 MedDRA version is allowed per ICSR.
For MedDRA version 15.1 value allowed is ‘15.1’.
G.k.7.r.2b Indication (MedDRA code)
User Guidance This data element captures the MedDRA LLT code for the indication of
the medicinal product.
Conformance Optional, but required if G.k.7.r.2a is provided.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)
When nullFlavor is used in G.k.7.r.1, the MedDRA term ‘Drug use for
unknown indication’ (LLT=10057097) should be used.
ICH ICSR Implementation Guide 12 April 2013
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G.k.7.r Indication for Use in Case (repeat as necessary)
G.k.7.r.1 Indication as Reported by the Primary Source
User Guidance This data element captures the original reporter's words and /or short
phrases used to describe the indication for drug use in an English
translation for international transmission. ‘Not specified’ or ‘Unknown’
can be used if the source has not provided or does not know the
information, respectively.
Conformance Optional
Data Type 250AN
OID None
Value Allowed Free text
nullFlavor: ASKU, NASK, UNK
Business Rule(s)
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
Please use nullFlavor with original text attribute in XML instance (See
Appendix I (D) the Reference Instance).
G.k.7.r.2a MedDRA Version for Indication
User Guidance This data element provides the MedDRA version for G.k.7.r.2b
Conformance Optional, but required if G.k.7.r.2b is populated.
Data Type 4AN
OID None
Value Allowed Numeric and ‘. ‘(dot)
Business Rule(s)
Only 1 MedDRA version is allowed per ICSR.
For MedDRA version 15.1 value allowed is ‘15.1’.
G.k.7.r.2b Indication (MedDRA code)
User Guidance This data element captures the MedDRA LLT code for the indication of
the medicinal product.
Conformance Optional, but required if G.k.7.r.2a is provided.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)
When nullFlavor is used in G.k.7.r.1, the MedDRA term ‘Drug use for
unknown indication’ (LLT=10057097) should be used.