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ICH ICSR Implementation Guide 12 April 2013
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D.7.1.r.5 Comments
User Guidance This data element provides additional relevant information about the
‘medical condition’ in D.7.1.r.1b that could not be captured otherwise in a
structured data element. For example, in case of prematurity, the birth
weight should be recorded here or in the absence of imprecise dates, a
text description that would aid in understanding the medical history (e.g.
‘since childhood’) can also be provided here.
Conformance Optional
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)
D.7.1.r.6 Family History
User Guidance This data element captures is set to ‘true’ when the medical information
provided in the ‘Structured Information on Relevant Medical
History’(D.7.1.r) is reported also to be present in another family member
(e.g. hereditary diseases). However, this data element is not used when
the same medical concept is already provided in the ‘Relevant Medical
History and Concurrent Conditions of Parent’(D.10.7). When this data
element is set to ‘true’, detailed information should be provided in the
narrative Section H.1.
Conformance Optional
Data Type Boolean
OID None
Value Allowed True
Business Rule(s)
When Parent Medical history already is provided in D.10.7, do not set this
data element to ‘true’ (Yes) for similar medical concepts also coded for
the patient.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including
reaction /event)
User Guidance This data element captures information about any other medical history
that could not be coded in D.7.1.r.
Also, the term ‘None’ should be used here when there is no relevant
medical history and no concurrent conditions reported.
If relevant medical history is not documented at the time of the report, this
data element is set to unknown (i.e. nullFlavor=UNK) and should not be
confused with ‘None’.
Conformance Optional, but required if Section D.7.1 is null.
Data Type 10000AN
OID None
Value Allowed Free text
ICH ICSR Implementation Guide 12 April 2013
-84-
D.7.1.r.5 Comments
User Guidance This data element provides additional relevant information about the
‘medical condition’ in D.7.1.r.1b that could not be captured otherwise in a
structured data element. For example, in case of prematurity, the birth
weight should be recorded here or in the absence of imprecise dates, a
text description that would aid in understanding the medical history (e.g.
‘since childhood’) can also be provided here.
Conformance Optional
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)
D.7.1.r.6 Family History
User Guidance This data element captures is set to ‘true’ when the medical information
provided in the ‘Structured Information on Relevant Medical
History’(D.7.1.r) is reported also to be present in another family member
(e.g. hereditary diseases). However, this data element is not used when
the same medical concept is already provided in the ‘Relevant Medical
History and Concurrent Conditions of Parent’(D.10.7). When this data
element is set to ‘true’, detailed information should be provided in the
narrative Section H.1.
Conformance Optional
Data Type Boolean
OID None
Value Allowed True
Business Rule(s)
When Parent Medical history already is provided in D.10.7, do not set this
data element to ‘true’ (Yes) for similar medical concepts also coded for
the patient.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including
reaction /event)
User Guidance This data element captures information about any other medical history
that could not be coded in D.7.1.r.
Also, the term ‘None’ should be used here when there is no relevant
medical history and no concurrent conditions reported.
If relevant medical history is not documented at the time of the report, this
data element is set to unknown (i.e. nullFlavor=UNK) and should not be
confused with ‘None’.
Conformance Optional, but required if Section D.7.1 is null.
Data Type 10000AN
OID None
Value Allowed Free text