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ICH ICSR Implementation Guide 12 April 2013
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E.i.1 Reaction /Event as Reported by the Primary Source
E.i.1.1a Reaction /Event as Reported by the Primary Source in Native Language
User Guidance This data element captures the original reporter's words and/or short
phrases used to describe the reaction/event. Text should be provided in the
native language it was received, when it is received in a language other
than English.
Conformance Optional
Data Type 250AN
OID None
Value Allowed Free text
Business Rule(s)
E.i.1.1b Reaction /Event as Reported by the Primary Source Language
User Guidance Provide the language used in E.i.1.1a by using a International Standard,
Codes for the representation of names of languages-- Part 2: alpha-3
code.
Conformance Optional, but required if E.i.1.1a is populated.
Data Type 3A
OID 2.16.840.1.113883.6.100
Value Allowed ISO 639-2/RA, alpha-3
Business Rule(s)
E.i.1.2 Reaction /Event as Reported by the Primary Source for Translation
User Guidance This data element captures the original reporter's words and/or short
phrases used to describe the reaction/event should be provided in an
English translation for international transmission.
Conformance Optional
Data Type 250AN
OID None
Value Allowed Free text
Business Rule(s)
E.i.2.1a MedDRA Version for Reaction /Event
User Guidance This data element provides the MedDRA version for E.i.2.1b.
Conformance Required
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’.