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ICH ICSR Implementation Guide 12 April 2013
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D.4 Height (cm)
User Guidance This data element captures the reported height of the patient in centimetres
at the time of the event/reaction.
Conformance Optional
Data Type 3N
OID None
Value Allowed Numeric
Business Rule(s)
Provide rounded number. No fractions, decimals, and commas are allowed
in this numeric data element.
D.5 Sex
User Guidance This data element captures the sex of the patient.
Conformance Optional
Data Type 1N
OID 1.0.5218
Value Allowed 1=Male
2=Female
nullFlavor: MSK, UNK, ASKU, NASK
Business Rule(s)
If the sex is known to the sender but cannot be transmitted due to data
privacy requirements, then leave the data element blank and use the
nullFlavor element with ‘MSK’ as masked.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.6 Last Menstrual Period Date
User Guidance This data element captures the date of the last menstrual period of the
patient when it is relevant. Imprecise dates can be included (e.g. month
and year, or year only).Other information on menopause or conditions
related to menopause should be captured in the data element D.7.1.r.
If this report is for a child/foetus, then the mother’s last menstrual period
is captured in the data element D.10.3.
Conformance Optional
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
nullFlavor: MSK
Business Rule(s)
Minimum precision required is the year (i.e. ‘CCYY’).
The date specified cannot refer to a future date.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.