99
ICH ICSR Implementation Guide 12 April 2013
-100-
D.10.8.r.7b Reactions (MedDRA code)
User Guidance Medical judgment should be exercised in completing this data element.
The information provided here describes previous experience of the parent
with the drug described in D.10.8.r.
Conformance Optional, but required if D.10.8.r.7a 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
-100-
D.10.8.r.7b Reactions (MedDRA code)
User Guidance Medical judgment should be exercised in completing this data element.
The information provided here describes previous experience of the parent
with the drug described in D.10.8.r.
Conformance Optional, but required if D.10.8.r.7a is populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)