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D.7 Relevant Medical History and Concurrent Conditions (not including reaction /event)
D.7.1.r Structured Information on Relevant Medical History (repeat as necessary)
Medical judgment should be exercised in completing this section. Only information pertinent to
understanding the case is desired (such as diseases, conditions such as pregnancy, surgical
procedures, psychological trauma, risk factors, etc.). In case of prematurity, the birth weight
when known should be recorded in the data element ‘Comments’ (D.7.1.r.5). If precise dates are
not known and a text description is pertinent to understanding the medical history, or if concise
additional information is helpful in showing the relevance of the past medical history, such
information can be included in the ‘Comments’ (D.7.1.r.5). In order to identify relevant medical
information of the family (e.g. hereditary diseases), the data element ‘Family History’
(D.7.1.r.6) should be set to ‘true’ (Yes) for the appropriate medical history of the patient.
If there is no relevant medical history and no concurrent conditions for inclusion in D.7.1, then
D.7.2 is required. If the reason is that the relevant medical history is not documented at the time
of the report then the value for D.7.2 is ‘Unknown’. This should not be confused with ‘None’.
In the first case the NullFlavor is used with the value ‘UNK’ and in the second case the text
‘None’ will be transmitted.
The designation of ‘r’ in this section indicates that each item is repeatable and that it
corresponds to the same ‘r’ in all subsections. A separate block (r) should be used for each
relevant medical history term. For example, if two conditions are reported, the first condition
would be described in items D.7.1.1.1 through D.7.1.1.6, and the other condition would be
described in items D.7.1.2.1 through D.7.1.2.6.
D.7.1.r.1a MedDRA Version for Medical History
User Guidance This data element provides the MedDRA version for D.7.1.r.1b.
Conformance Optional, but required if D.7.1.r.1b is populated.
Data Type 4AN
OID None
Value Allowed Numeric and ‘. ‘(dot)
Business Rule(s)
Only 1 MedDRA version is allowed per ICSR.
For MedDRA version 15.1 value allowed is ‘15.1’.
D.7.1.r.1b Medical History (disease /surgical procedure /etc.) (MedDRA code)
User Guidance See Section D.7.1.r.
Conformance Optional, but required if D.7.1.r.1a is populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)
ICH ICSR Implementation Guide 12 April 2013
-82-
D.7 Relevant Medical History and Concurrent Conditions (not including reaction /event)
D.7.1.r Structured Information on Relevant Medical History (repeat as necessary)
Medical judgment should be exercised in completing this section. Only information pertinent to
understanding the case is desired (such as diseases, conditions such as pregnancy, surgical
procedures, psychological trauma, risk factors, etc.). In case of prematurity, the birth weight
when known should be recorded in the data element ‘Comments’ (D.7.1.r.5). If precise dates are
not known and a text description is pertinent to understanding the medical history, or if concise
additional information is helpful in showing the relevance of the past medical history, such
information can be included in the ‘Comments’ (D.7.1.r.5). In order to identify relevant medical
information of the family (e.g. hereditary diseases), the data element ‘Family History’
(D.7.1.r.6) should be set to ‘true’ (Yes) for the appropriate medical history of the patient.
If there is no relevant medical history and no concurrent conditions for inclusion in D.7.1, then
D.7.2 is required. If the reason is that the relevant medical history is not documented at the time
of the report then the value for D.7.2 is ‘Unknown’. This should not be confused with ‘None’.
In the first case the NullFlavor is used with the value ‘UNK’ and in the second case the text
‘None’ will be transmitted.
The designation of ‘r’ in this section indicates that each item is repeatable and that it
corresponds to the same ‘r’ in all subsections. A separate block (r) should be used for each
relevant medical history term. For example, if two conditions are reported, the first condition
would be described in items D.7.1.1.1 through D.7.1.1.6, and the other condition would be
described in items D.7.1.2.1 through D.7.1.2.6.
D.7.1.r.1a MedDRA Version for Medical History
User Guidance This data element provides the MedDRA version for D.7.1.r.1b.
Conformance Optional, but required if D.7.1.r.1b is populated.
Data Type 4AN
OID None
Value Allowed Numeric and ‘. ‘(dot)
Business Rule(s)
Only 1 MedDRA version is allowed per ICSR.
For MedDRA version 15.1 value allowed is ‘15.1’.
D.7.1.r.1b Medical History (disease /surgical procedure /etc.) (MedDRA code)
User Guidance See Section D.7.1.r.
Conformance Optional, but required if D.7.1.r.1a is populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)