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ICH ICSR Implementation Guide 12 April 2013
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G.k.4.r.9 Pharmaceutical Dose Form
G.k.4.r.9.1 Pharmaceutical Dose Form (free text)
User Guidance This data element captures a free text description of the pharmaceutical
dose form when the ‘Pharmaceutical Dose Form TermID’ (G.k.4.r.9.2b)
is not available.
Conformance Optional
Data Type 60 AN
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.
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number
User Guidance This data element provides the version date for the Pharmaceutical Dose
Form TermID.
Conformance Optional, but required if the ‘Pharmaceutical Dose Form TermID’
(G.k.4.r.9.2b)is provided.
Data Type Refer to M5 IG.
OID None
Value Allowed Refer to M5 IG.
Business Rule(s)
G.k.4.r.9.2bPharmaceutical Dose Form TermID
User Guidance If PhPID (G.k.2.1.2) is unavailable, the pharmaceutical dose form should
be provided as a TermID using the ICH M5 Pharmaceutical Dose Form
controlled vocabulary. If the Pharmaceutical Dose Form TermID is not
available, free text in G.k.4.r.9.1 should be used.
Conformance Optional
Data Type Refer to M5 IG.
OID Refer to M5 IG.
Value Allowed Refer to M5 IG.
Business Rule(s)
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