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ICH ICSR Implementation Guide 12 April 2013
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D.8.r.6a MedDRA Version for Indication
User Guidance This data element provides the MedDRA version for D.8.r.6b.
Conformance Optional, but required if D.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.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.8.r.6a is populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)
D.8.r.7a MedDRA Version for Reaction
User Guidance This data element provides the MedDRA version for D.8.r.7b.
Conformance Optional, but required if D.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’.
D.8.r.7bReaction (MedDRA code)
User Guidance Medical judgment should be exercised in completing this data element.
The information provided here describes previous experience with the
drug described in D.8.r.See Section D.8.r. A MedDRA LLT code should
be used.
Conformance Optional, but required if D.8.r.7a is populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)