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ICH ICSR Implementation Guide 12 April 2013
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G.k.9.i.3.1a Time Interval between Beginning of Drug Administration and Start of
Reaction /Event (number)
User Guidance This data element captures the value (amount) for the interval of time
between the start of drug administration and the onset of the reaction.
Even when other dates are provided, this data element is useful also to be
transmitted for circumstances where, for example the interval is very short
minutes, such as in anaphylaxis, or in which only imprecise dates are
known but more information concerning the interval is known. If the
sender wants to provide time intervals as well as dates, then the date of the
first day of administration should be counted as Day 1 of the interval.
Conformance Optional, but required if G.k.9.i.3.1b is populated.
Data Type 5N
OID None
Value Allowed Numeric
Business Rule(s)
G.k.9.i.3.1b Time Interval between Beginning of Drug Administration and Start of
Reaction /Event (unit)
User Guidance This data element captures the unit for the value in G.k.9.i.3.1a.
Conformance Optional, but required if G.k.9.i.3.1a 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.3.2a Time Interval between Last Dose of Drug and Start of Reaction /Event
(number)
User Guidance This data element captures the value (amount) for the interval of time
between the end of drug administration and the onset of the reaction. Even
when other dates are provided, this data element is useful also to be
transmitted for circumstances where, for e.g. the interval is very short
minutes, such as in anaphylaxis, or in which only imprecise dates are
known but more information concerning the interval is known. If the
sender wants to provide time intervals as well as dates, then the date of the
last day of administration should be counted as Day 1 of the interval.
Conformance Optional, but required if G.k.9.i.3.2b is populated.
Data Type 5N
OID None
Value Allowed Numeric
Business Rule(s)
ICH ICSR Implementation Guide 12 April 2013
-135-
G.k.9.i.3.1a Time Interval between Beginning of Drug Administration and Start of
Reaction /Event (number)
User Guidance This data element captures the value (amount) for the interval of time
between the start of drug administration and the onset of the reaction.
Even when other dates are provided, this data element is useful also to be
transmitted for circumstances where, for example the interval is very short
minutes, such as in anaphylaxis, or in which only imprecise dates are
known but more information concerning the interval is known. If the
sender wants to provide time intervals as well as dates, then the date of the
first day of administration should be counted as Day 1 of the interval.
Conformance Optional, but required if G.k.9.i.3.1b is populated.
Data Type 5N
OID None
Value Allowed Numeric
Business Rule(s)
G.k.9.i.3.1b Time Interval between Beginning of Drug Administration and Start of
Reaction /Event (unit)
User Guidance This data element captures the unit for the value in G.k.9.i.3.1a.
Conformance Optional, but required if G.k.9.i.3.1a 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.3.2a Time Interval between Last Dose of Drug and Start of Reaction /Event
(number)
User Guidance This data element captures the value (amount) for the interval of time
between the end of drug administration and the onset of the reaction. Even
when other dates are provided, this data element is useful also to be
transmitted for circumstances where, for e.g. the interval is very short
minutes, such as in anaphylaxis, or in which only imprecise dates are
known but more information concerning the interval is known. If the
sender wants to provide time intervals as well as dates, then the date of the
last day of administration should be counted as Day 1 of the interval.
Conformance Optional, but required if G.k.9.i.3.2b is populated.
Data Type 5N
OID None
Value Allowed Numeric
Business Rule(s)