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ICH ICSR Implementation Guide 12 April 2013
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G.k.4.r.11 Parent Route of Administration (in case of a parent child /foetus report)
G.k.4.r.11.1 Parent Route of Administration (free text)
User Guidance This data element captures a free text description of the route of
administration when the ‘Parent Route of Administration TermID’
(G.k.4.r.11.2b)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.11.2a Parent 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.11.2b is provided.
Data Type Refer to M5 IG.
OID None
Value Allowed Refer to M5 IG.
Business Rule(s)
G.k.4.r.11.2b Parent Route of Administration TermID
User Guidance This data element captures the known route of administration of the drug
as taken by the parent for the dosage described in G.k.4.r.1 to G.k.4.r.3.
The parent’s 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.
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)
ICH ICSR Implementation Guide 12 April 2013
-129-
G.k.4.r.11 Parent Route of Administration (in case of a parent child /foetus report)
G.k.4.r.11.1 Parent Route of Administration (free text)
User Guidance This data element captures a free text description of the route of
administration when the ‘Parent Route of Administration TermID’
(G.k.4.r.11.2b)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.11.2a Parent 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.11.2b is provided.
Data Type Refer to M5 IG.
OID None
Value Allowed Refer to M5 IG.
Business Rule(s)
G.k.4.r.11.2b Parent Route of Administration TermID
User Guidance This data element captures the known route of administration of the drug
as taken by the parent for the dosage described in G.k.4.r.1 to G.k.4.r.3.
The parent’s 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.
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)