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G.k.4.r.10 Route of Administration
G.k.4.r.10.1 Route of Administration (free text)
User Guidance This data element captures a free text description of the route of
administration when the ‘Route of Administration TermID’
(G.k.4.r.10.2b) is not available. An appropriate nullFlavor can be used if
the source has not provided or does not know the information.
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.10.2a Route of Administration TermID Version Date /Number
User Guidance This data element provides the version date for the Route of
Administration TermID.
Conformance Optional, but required if G.k.4.r.10.2b is provided.
Data Type Refer to M5 IG.
OID None
Value Allowed Refer to M5 IG.
Business Rule(s)
Until M5 TermID is available, use version number in the ICH E2B(R3)
code list 14.
G.k.4.r.10.2b Route of Administration TermID
User Guidance Route of administration should be provided as TermID using the ICH M5
Route of administration controlled vocabulary. Until M5 is available, use
the existing code list attached in Appendix I (F).No other identifiers
should be used in this data element.
For a parent-child/foetus report, this data element indicates the route of
administration for the child/foetus (patient). This is usually an indirect
exposure, such as transmammary, but can include more usual routes of
administration for other drugs given to the child. The parent’s route of
administration should be provided in G.k.4.r.11.
Conformance Optional
Data Type Refer to M5 IG.
Until M5 is available, this is 3N.
OID Refer to M5 IG.
Until M5 is available, use 2.16.840.1.113883.3.989.2.1.1.14.
Value Allowed Refer to M5 IG.
Until M5 is available, use code list in Appendix I (F).
Business Rule(s)