97
ICH ICSR Implementation Guide 12 April 2013
-98-
D.10.8.r.2b Medicinal Product Identifier (MPID)
User Guidance See Section D.8.r.
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.10.8.r.3a PhPID Version Date/Number
User Guidance See Section D.8.r.
Conformance Optional, but required if D.10.8.r.3b is populated.
Data Type Refer to M5 IG.
OID None
Value Allowed Refer to M5 IG.
Business Rule(s)
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID)
User Guidance See Section D.8.r.
Conformance Optional, not allowed if D.10.8.r.2b is populated.
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.10.8.r.4 Start Date
User Guidance This data element captures the start 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.