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ICH ICSR Implementation Guide 12 April 2013
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D.10.5 Height (cm) of Parent
User Guidance This data element captures the reported height of the parent in centimetres.
Conformance Optional
Data Type 3N
OID None
Value Allowed Numeric
Business Rule(s)
Provide rounded number. No fractions, decimals, and commas are allowed
in this numeric data element
D.10.6 Sex of Parent
User Guidance This data element captures the sex of the parent.
Conformance Required if any data element in D.10 section is populated.
Data Type 1N
OID 1.0.5218
Value Allowed 1=Male
2=Female
nullFlavor: UNK, MSK, ASKU, NASK
Business Rule(s)
If the sex of the parent is known to the sender but cannot be transmitted
due to data privacy requirements, this data element should be left blank
with nullFlavor =MSK.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.10.7 Relevant Medical History and Concurrent Conditions of Parent
D.10.7.1.r Structured Information of Parent (repeat as necessary)
D.10.7.1.r.1a MedDRA Version for Medical History
User Guidance This data element provides the MedDRA version for D.10.7.1.r.1b
Conformance Optional, but required if D.10.7.1.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.10.7.1.r.1b Medical History (disease /surgical procedure /etc.) (MedDRA code)
User Guidance This data element captures the MedDRA LLT code for the medical
condition of the parent. See Section D.7.1.r.
Conformance Optional, but required if D.10.7.1.r.1a is populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
ICH ICSR Implementation Guide 12 April 2013
-95-
D.10.5 Height (cm) of Parent
User Guidance This data element captures the reported height of the parent in centimetres.
Conformance Optional
Data Type 3N
OID None
Value Allowed Numeric
Business Rule(s)
Provide rounded number. No fractions, decimals, and commas are allowed
in this numeric data element
D.10.6 Sex of Parent
User Guidance This data element captures the sex of the parent.
Conformance Required if any data element in D.10 section is populated.
Data Type 1N
OID 1.0.5218
Value Allowed 1=Male
2=Female
nullFlavor: UNK, MSK, ASKU, NASK
Business Rule(s)
If the sex of the parent is known to the sender but cannot be transmitted
due to data privacy requirements, this data element should be left blank
with nullFlavor =MSK.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.10.7 Relevant Medical History and Concurrent Conditions of Parent
D.10.7.1.r Structured Information of Parent (repeat as necessary)
D.10.7.1.r.1a MedDRA Version for Medical History
User Guidance This data element provides the MedDRA version for D.10.7.1.r.1b
Conformance Optional, but required if D.10.7.1.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.10.7.1.r.1b Medical History (disease /surgical procedure /etc.) (MedDRA code)
User Guidance This data element captures the MedDRA LLT code for the medical
condition of the parent. See Section D.7.1.r.
Conformance Optional, but required if D.10.7.1.r.1a is populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric