125
ICH ICSR Implementation Guide 12 April 2013
-126-
Section. The information requested is the overall duration of drug
administration and covers intermittent administration. This data element
captures the value (quantity) for the duration of the administration.
Conformance Optional, but required if G.k.4.r.6b is populated.
Data Type 5N
OID None
Value Allowed Numeric
Business Rule(s)
G.k.4.r.6b Duration of Drug Administration (unit)
User Guidance This data element captures the unit for the ‘Duration of Drug
Administration’ (G.k.4.r.6a).
Conformance Optional, but required if G.k.4.r.6a is populated.
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.1.26
Value Allowed Constrained UCUM codes
Business Rule(s)
G.k.4.r.7 Batch /Lot Number
User Guidance This data element captures the batch or lot number for the medicinal
product.This information is particularly important for vaccines and
biologics. The most specific information available should be provided.
For expiration date and other related information, see the Additional
Information on Drug (G.k.11).
Conformance Optional
Data Type 35AN
OID None
Value Allowed Free text
Business Rule(s)
G.k.4.r.8 Dosage Text
User Guidance This data element captures free text information when structured dosage
information is not possible, or to provide more detail on structured dosage
data elements. There is no need to duplicate information provided in the
structured dosage data elements.
Conformance Optional
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)
ICH ICSR Implementation Guide 12 April 2013
-126-
Section. The information requested is the overall duration of drug
administration and covers intermittent administration. This data element
captures the value (quantity) for the duration of the administration.
Conformance Optional, but required if G.k.4.r.6b is populated.
Data Type 5N
OID None
Value Allowed Numeric
Business Rule(s)
G.k.4.r.6b Duration of Drug Administration (unit)
User Guidance This data element captures the unit for the ‘Duration of Drug
Administration’ (G.k.4.r.6a).
Conformance Optional, but required if G.k.4.r.6a is populated.
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.1.26
Value Allowed Constrained UCUM codes
Business Rule(s)
G.k.4.r.7 Batch /Lot Number
User Guidance This data element captures the batch or lot number for the medicinal
product.This information is particularly important for vaccines and
biologics. The most specific information available should be provided.
For expiration date and other related information, see the Additional
Information on Drug (G.k.11).
Conformance Optional
Data Type 35AN
OID None
Value Allowed Free text
Business Rule(s)
G.k.4.r.8 Dosage Text
User Guidance This data element captures free text information when structured dosage
information is not possible, or to provide more detail on structured dosage
data elements. There is no need to duplicate information provided in the
structured dosage data elements.
Conformance Optional
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)