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G.k.9.i.3.2b Time Interval between Last Dose of Drug and Start of Reaction /Event (unit)
User Guidance This data element capturesthe unit for the value in G.k.9.i.3.2a.
Conformance Optional, but required if G.k.9.i.3.2a 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.9.i.4 Did Reaction Recur on Re-administration?
User Guidance This data element indicates both if the patient was rechallenged with the
drug and the known outcome. This data element should not be coded if it
was not reported whether or not a rechallenge was done.
Conformance Optional
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.16
Value Allowed 1=yes – yes (rechallenge was done, reaction recurred)
2=yes – no (rechallenge was done, reaction did not recur)
3=yes – unk (rechallenge was done, outcome unknown)
4=no – n/a (no rechallenge was done, recurrence is not applicable)
Business Rule(s)
If the sender does not know whether a rechallenge was performed, this
data element should not be transmitted.
G.k.10.r Additional Information on Drug (coded) (repeat as necessary)
User Guidance This data element capturesany additional information pertinent to the case
that is not covered by the sections above. For example, cases where the
suspect drug was taken by the father, this should be indicated in this data
element as ‘3’ (Drug taken by the father). If the additional information
cannot be described by G.k.10.r,then use the data element G.k.11.
Conformance Optional
Data Type 2N
OID 2.16.840.1.113883.3.989.2.1.1.17
Value Allowed 1=Counterfeit
2=Overdose
3=Drug taken by the father
4=Drug taken beyond expiry date
5=Batch and lot tested and found within specifications
6=Batch and lot tested and found not within specifications
7=Medication error
8=Misuse
9=Abuse
10=Occupational exposure
11=Off label use
Business Rule(s)
ICH ICSR Implementation Guide 12 April 2013
-136-
G.k.9.i.3.2b Time Interval between Last Dose of Drug and Start of Reaction /Event (unit)
User Guidance This data element capturesthe unit for the value in G.k.9.i.3.2a.
Conformance Optional, but required if G.k.9.i.3.2a 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.9.i.4 Did Reaction Recur on Re-administration?
User Guidance This data element indicates both if the patient was rechallenged with the
drug and the known outcome. This data element should not be coded if it
was not reported whether or not a rechallenge was done.
Conformance Optional
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.16
Value Allowed 1=yes – yes (rechallenge was done, reaction recurred)
2=yes – no (rechallenge was done, reaction did not recur)
3=yes – unk (rechallenge was done, outcome unknown)
4=no – n/a (no rechallenge was done, recurrence is not applicable)
Business Rule(s)
If the sender does not know whether a rechallenge was performed, this
data element should not be transmitted.
G.k.10.r Additional Information on Drug (coded) (repeat as necessary)
User Guidance This data element capturesany additional information pertinent to the case
that is not covered by the sections above. For example, cases where the
suspect drug was taken by the father, this should be indicated in this data
element as ‘3’ (Drug taken by the father). If the additional information
cannot be described by G.k.10.r,then use the data element G.k.11.
Conformance Optional
Data Type 2N
OID 2.16.840.1.113883.3.989.2.1.1.17
Value Allowed 1=Counterfeit
2=Overdose
3=Drug taken by the father
4=Drug taken beyond expiry date
5=Batch and lot tested and found within specifications
6=Batch and lot tested and found not within specifications
7=Medication error
8=Misuse
9=Abuse
10=Occupational exposure
11=Off label use
Business Rule(s)