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ICH ICSR Implementation Guide 12 April 2013
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H.4 Sender's Comments
User Guidance This data element captures the sender's assessment of the case and can be
used to describe disagreement with, and/or alternatives to the diagnoses
given by the reporter(s).Also, in case of linkage of multiple ICSRs using
C.1.10.r, the reason should be provided in these comments.
Conformance Optional
Data Type 20000AN
OID None
Value Allowed Free text
Business Rule(s)
H.5.r Case Summary and Reporter’s Comments in Native Language (repeat as necessary)
This section provides information on the clinical course of the case, therapeutic measures,
outcome and other relevant information, as well as the reporter’s comments on the case in a
language different from that used in Sections H.1, H.2, and H.4.
H.5.r.1a and H.5.r.1b are used in combination to transmit the sender’s and receiver’s comments
in a language other than English, as required in some countries and regions.
H.5.r.1a Case Summary and Reporter’s Comments Text
User Guidance See Section H.5.r.
Conformance Optional
Data Type 100000AN
OID None
Value Allowed Free text
Business Rule(s)
H.5.r.1b Case Summary and Reporter’s Comments Language
User Guidance Provide the language used in H.5.r.1a by using a International Standard,
Codes for the representation of names of languages-- Part 2: alpha-3
code.
Conformance Required if H.5.r.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)
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