104
ICH ICSR Implementation Guide 12 April 2013
-105-
E.i.3.2e Congenital Anomaly /Birth Defect
User Guidance See Section E.i.3.2.
Conformance Required
Data Type Boolean
OID None
Value Allowed true
nullFlavor: NI
Business Rule(s)
E.i.3.2f Other Medically Important Condition
User Guidance See Section E.i.3.2.
Conformance Required
Data Type Boolean
OID None
Value Allowed true
nullFlavor: NI
Business Rule(s)
E.i.4 Date of Start of Reaction /Event
User Guidance This data element captures the date of the start of the reaction/event.When
multiple terms are reported (e.g. diagnosis with signs and symptoms) and
the reporter does not provide a specific onset date for each reaction/event,
this data element should be populated with the start date of the first
symptom.
Conformance Optional
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
nullFlavor: MSK, ASKU, NASK
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.
Previous Page Next Page