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ICH ICSR Implementation Guide 12 April 2013
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Code Name Definition
ASKU Asked But
Unknown
Information was sought but not found (e.g. patient was asked
but didn't know)
NASK Not Asked This information has not been sought (e.g. patient was not
asked)
NINF Negative
Infinity Negative infinity of numbers.
PINF Positive
Infinity Positive infinity of numbers.
The following examples demonstrate how a nullFlavor can be used to code values in the ICH
ICSR. In these examples, the name of the data element appears after each coded value in a !--
comment tag--:
Example 1.‘Masked’ is expressed by nullFlavor =MSK.
componenttypeCode="COMP"
adverseEventAssessmentclassCode="INVSTG"moodCode="EVN"
subject1typeCode="SBJ"
primaryRoleclassCode="INVSBJ"
player1classCode="PSN"determinerCode="INSTANCE"
namenullFlavor="MSK"/
!--D.1: Patient (name or initials) --
administrativeGenderCode code="D.5"codeSystem="1.0.5218"/
!--D.5 Sex [1] Male [2]Female--
birthTime value="19200101"/
!--D.2.1: Date of Birth --
deceasedTime value="20090101"/
Example2.‘Unknown’ is expressed by nullFlavor=UNK.
roleclassCode="PRS"
code code="PRN"codeSystem="2.16.840.1.113883.5.111"/
associatedPersondeterminerCode="INSTANCE"classCode="PSN"
namenullFlavor="UNK"/
!--D.10.1: Parent Identification--
administrativeGenderCode code="D.10.6"codeSystem="1.0.5218"/
!--D.10.6: Sex of Parent [1]Male [2]Female--
birthTime value="19730101"/
!--D.10.2.1: Date of Birth of Parent --
/associatedPerson