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ICH ICSR Implementation Guide 12 April 2013
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G.k.2.3.r.1 Substance /Specified Substance Name
User Guidance If a ‘Substance Name TermID’ (G.k.2.3.r.2b) is not available, provide a
text description of the substance. A medical device can be described here.
Conformance Required if either of G.k.2.1.1, G.k.2.1.2or G.k.2.3.r.2b Substance Name
TermID is unavailable.
Data Type 250 AN
OID None
Value Allowed Free text
Business Rule(s)
G.k.2.3.r.2a Substance/Specified Substance TermID Version Date/Number
User Guidance This data element provides the version date for the Substance Name
TermID.
Conformance Optional, but required if G.k.2.3.r.2b is provided.
Data Type Refer to M5 IG.
OID None
Value Allowed Refer to M5 IG.
Business Rule(s)
G.k.2.3.r.2b Substance/Specified Substance TermID
User Guidance If both MPID (G.k.2.1.1) and PhPID (G.k.2.1.2) are unavailable, use the
Substance Name TermID. Until the ICH M5 IG is available, this data
element will be left blank.
Conformance Optional
Data Type Refer to M5 IG.
OID Refer to M5 IG.
Value Allowed Refer to M5 IG.
Business Rule(s)
G.k.2.3.r.3a Strength (number)
User Guidance If PhPID (G.k.2.1.2) is unavailable, this data element provides the lower
numerator of the strength for the substance or if not a range, the numerator
of the strength when known.
Conformance Optional
Data Type 10N
OID None
Value Allowed Numeric
Business Rule(s)