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ICH ICSR Implementation Guide 12 April 2013
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D.2.2.1b Gestation Period When Reaction/Event Was Observed in the Foetus (unit)
User Guidance This data element captures the unit for the value of the gestation period
when the reaction/event was observed in the foetus.
Conformance Optional, but required if D.2.2.1a is populated.
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.1.26
Value Allowed UCUM codes for Month, Week, and Day:{Trimester}
Business Rule(s)
D.2.3 Patient Age Group (as per reporter)
User Guidance The terms in Value Allowed for this data element are not defined in this
document and are intended to reflect the term used by the reporter (i.e. as
they were reported by the primary source).This section should be
completed only when the age is not provided with any more precision (e.g.
Sections D.2.1 or D.2.2 is blank).
Conformance Optional
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.9
Value Allowed 0=Foetus
1=Neonate (Preterm and Term newborns)
2=Infant
3=Child
4=Adolescent
5=Adult
6=Elderly
Business Rule(s)
D.3 Body Weight (kg)
User Guidance This data element captures the reported body weight of the patient in
kilograms at the time of the event/reaction.
Conformance Optional
Data Type 6N
OID None
Value Allowed Numeric
Business Rule(s)
Fractions or decimals are allowed using a period (dot).No commas are
allowed in this numeric data element.