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ICH ICSR Implementation Guide 12 April 2013
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D.10.8.r.5 End Date
User Guidance This data element captures the stop date of relevant past drug history for
the parent.
Conformance Optional
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
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.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.10.8.r.6a MedDRA Version for Indication
User Guidance This data element provides the MedDRA version for D.10.8.r.6b.
Conformance Optional, but required if D.10.8.r.6b 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.10.8.r.6b Indication (MedDRA code)
User Guidance This data element captures the MedDRA LLT code for the indication of
the medicinal product.
Conformance Optional, but required if D.10.8.r.6a is populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)
D.10.8.r.7a MedDRA Version for Reaction
User Guidance This data element provides the MedDRA version for D.10.8.r.7b
Conformance Optional, but required if D.10.8.r.7b 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’.
ICH ICSR Implementation Guide 12 April 2013
-99-
D.10.8.r.5 End Date
User Guidance This data element captures the stop date of relevant past drug history for
the parent.
Conformance Optional
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
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.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.10.8.r.6a MedDRA Version for Indication
User Guidance This data element provides the MedDRA version for D.10.8.r.6b.
Conformance Optional, but required if D.10.8.r.6b 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.10.8.r.6b Indication (MedDRA code)
User Guidance This data element captures the MedDRA LLT code for the indication of
the medicinal product.
Conformance Optional, but required if D.10.8.r.6a is populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)
D.10.8.r.7a MedDRA Version for Reaction
User Guidance This data element provides the MedDRA version for D.10.8.r.7b
Conformance Optional, but required if D.10.8.r.7b 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’.