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ICH ICSR Implementation Guide 12 April 2013
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D.8.r.1 Name of Drug as Reported
User Guidance This data element captures the name of the medicinal product as used by
the reporter. It is recognized that a single product can have different
proprietary names in different countries, even when it is produced by a
single manufacturer. Trade name, generic name or class of drug can be
used.
Conformance Required
Data Type 250AN
OID None
Value Allowed Free text
nullFlavor: NA*
Business Rule(s)
*Nullflavor=NA should be used when there is no previous exposure to a
drug or vaccine.
D.8.r.2a MPID Version Date/Number
User Guidance This data element provides the version date for D.8.r.2b.
Conformance Optional, but required if D.8.r.2b is populated.
Data Type Refer to M5 IG.
OID None
Value Allowed Refer to M5 IG.
Business Rule(s)
D.8.r.2b Medicinal Product Identifier (MPID)
User Guidance Based on D.8.r.1 and the ICH M5 IG, this data element captures the most
specific identifier, being either the MPID or the PhPID. If an MPID or a
PhPID for the reported medicinal product is not available, these data
elements should be left blank.
Conformance Optional
Data Type Refer to M5 IG.
OID Refer to M5 IG.
Value Allowed Refer to M5 IG.
Business Rule(s)
Any given drug entry may have either MPID or PhPID, but NOT both.
D.8.r.3a PhPID Version Date/Number
User Guidance This data element provides the version date for D.8.r.3b.
Conformance Optional, but required if D.8.r.3b is populated.
Data Type Refer to M5 IG.
OID None
Value Allowed Refer to M5 IG.
Business Rule(s)