136
ICH ICSR Implementation Guide 12 April 2013
-137-
G.k.11 Additional Information on Drug (free text)
User Guidance This data element captures any additional drug information in free text
format not described in G.k.10.r. For example, expiry date for the lot
number described in G.k.4.r.7 would be captured in this data element.
Conformance Optional
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)
If provided, this element needs to be separated and independent from any
value selected in the code list for G.k.10.r.
ICH ICSR Implementation Guide 12 April 2013
-137-
G.k.11 Additional Information on Drug (free text)
User Guidance This data element captures any additional drug information in free text
format not described in G.k.10.r. For example, expiry date for the lot
number described in G.k.4.r.7 would be captured in this data element.
Conformance Optional
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)
If provided, this element needs to be separated and independent from any
value selected in the code list for G.k.10.r.