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For a dosage regimen that involves more than one dosage form, and where provision of
structured dosage information is not possible, the information should be provided as text in
SectionG.k.4.r.8.
Note: More dosing examples are provided in Appendix I (G)
G.k.4.r.1a Dose (number)
User Guidance This data element captures the value (number) of each administered dose.
Conformance Optional
Data Type 8N
OID None
Value Allowed Numeric
Business Rule(s)
G.k.4.r.1b Dose (unit)
User Guidance This data element captures the unit for the dose value in G.k.4.r.1a.
Conformance Optional, but required if G.k.4.r.1a is populated.
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.1.25
Value Allowed Constrained UCUM codes: {DF}
BusinessRule(s)
UCUM allows using non-unit expression for symbols not in UCUM. In
this case, {DF} can be used in XML message.
G.k.4.r.2 Number of Units in the Interval
User Guidance This data element captures the value (amount) for the time interval
between each administered dose (G.k.4.r.1aand G.k.4.r.1b) If either
G.k.4.r.2 or G.k.4.r.3 is unknown, both should be left blank unless the
definition of the time interval unit is ‘cyclical’, ‘as necessary’, or ‘total’.
Conformance Optional
Data Type 4N
OID None
Value Allowed Numeric
Business Rule(s)
G.k.4.r.3 Definition of the Time Interval Unit
User Guidance This data element captures the UCUM code that best describes the unit for
the dosing time interval (G.k.4.r.2).When a specific time interval for drug
administration is not known, but is confirmed that the drug is used
cyclically or as necessary, then ‘Cyclical’ or ‘As Necessary’ can be used
in this data element. When the total amount of a drug is provided without
any particular dose and dosing interval (e.g. in the case of an overdose),
the quantity and unit (G.k.4.r.1a and G.k.4.r.1b) is provided along with
ICH ICSR Implementation Guide 12 April 2013
-124-
For a dosage regimen that involves more than one dosage form, and where provision of
structured dosage information is not possible, the information should be provided as text in
SectionG.k.4.r.8.
Note: More dosing examples are provided in Appendix I (G)
G.k.4.r.1a Dose (number)
User Guidance This data element captures the value (number) of each administered dose.
Conformance Optional
Data Type 8N
OID None
Value Allowed Numeric
Business Rule(s)
G.k.4.r.1b Dose (unit)
User Guidance This data element captures the unit for the dose value in G.k.4.r.1a.
Conformance Optional, but required if G.k.4.r.1a is populated.
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.1.25
Value Allowed Constrained UCUM codes: {DF}
BusinessRule(s)
UCUM allows using non-unit expression for symbols not in UCUM. In
this case, {DF} can be used in XML message.
G.k.4.r.2 Number of Units in the Interval
User Guidance This data element captures the value (amount) for the time interval
between each administered dose (G.k.4.r.1aand G.k.4.r.1b) If either
G.k.4.r.2 or G.k.4.r.3 is unknown, both should be left blank unless the
definition of the time interval unit is ‘cyclical’, ‘as necessary’, or ‘total’.
Conformance Optional
Data Type 4N
OID None
Value Allowed Numeric
Business Rule(s)
G.k.4.r.3 Definition of the Time Interval Unit
User Guidance This data element captures the UCUM code that best describes the unit for
the dosing time interval (G.k.4.r.2).When a specific time interval for drug
administration is not known, but is confirmed that the drug is used
cyclically or as necessary, then ‘Cyclical’ or ‘As Necessary’ can be used
in this data element. When the total amount of a drug is provided without
any particular dose and dosing interval (e.g. in the case of an overdose),
the quantity and unit (G.k.4.r.1a and G.k.4.r.1b) is provided along with