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D.10 FOR A PARENT-CHILD /FOETUS REPORT, INFORMATION
CONCERNING THE PARENT
This section should be used in the case of a parent-child/foetus report where the parent had no
reaction/event. Otherwise, this section should not be used. See the user guidance for Section
D.
D.10.1 Parent Identification
User Guidance See the user guidance for D.1.
Conformance Optional
Data Type 60AN
OID None
Value Allowed Free text
nullFlavor: MSK, ASKU, NASK, UNK
Business Rule(s)
If the name or initials of the parent are unknown to the sender, this data
element should be left blank with nullFlavor=UNK.
If the name or initials are 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.10.2 Parent Age Information
The parent age at the time of reaction /event to the child /foetus should be used. Select only
one of the data elements from D.10.2.1 or D.10.2.2. The choice should be based upon the most
precise information available and in conformance with the regional confidentiality requirements.
If the full date of birth is not known, an incomplete date can be used. Alternatively, an
approximate age can be captured in Section D.10.2.2.
D.10.2.1 Date of Birth of Parent
User Guidance This data element captures the date of birth of the parent. An incomplete
date can be used.
Conformance Optional
Data Type Date /Time
OID None
Value Allowed nullFlavor: MSK, ASKU, NASK
Business Rule(s)
Minimum precision required is the year (i.e. ‘CCYY’).
The date specified cannot refer to a future date.
If the date of birth is known to the sender but cannot be transmitted due to
data privacy requirements, this data element should be left blank with
nullFlavor set to ‘MSK’.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
ICH ICSR Implementation Guide 12 April 2013
-93-
D.10 FOR A PARENT-CHILD /FOETUS REPORT, INFORMATION
CONCERNING THE PARENT
This section should be used in the case of a parent-child/foetus report where the parent had no
reaction/event. Otherwise, this section should not be used. See the user guidance for Section
D.
D.10.1 Parent Identification
User Guidance See the user guidance for D.1.
Conformance Optional
Data Type 60AN
OID None
Value Allowed Free text
nullFlavor: MSK, ASKU, NASK, UNK
Business Rule(s)
If the name or initials of the parent are unknown to the sender, this data
element should be left blank with nullFlavor=UNK.
If the name or initials are 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.10.2 Parent Age Information
The parent age at the time of reaction /event to the child /foetus should be used. Select only
one of the data elements from D.10.2.1 or D.10.2.2. The choice should be based upon the most
precise information available and in conformance with the regional confidentiality requirements.
If the full date of birth is not known, an incomplete date can be used. Alternatively, an
approximate age can be captured in Section D.10.2.2.
D.10.2.1 Date of Birth of Parent
User Guidance This data element captures the date of birth of the parent. An incomplete
date can be used.
Conformance Optional
Data Type Date /Time
OID None
Value Allowed nullFlavor: MSK, ASKU, NASK
Business Rule(s)
Minimum precision required is the year (i.e. ‘CCYY’).
The date specified cannot refer to a future date.
If the date of birth is known to the sender but cannot be transmitted due to
data privacy requirements, this data element should be left blank with
nullFlavor set to ‘MSK’.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to