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ICH ICSR Implementation Guide 12 April 2013
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C.3.2 Sender’s Organisation
User Guidance This data element captures the sender’s organisation name (e.g. company
name or regulatory authority name).
Conformance Required if the ‘Sender Type’ (C.3.1) is not coded as 7 (Patient /
Consumer).
Data Type 100AN
OID None
Value Allowed Free text
Business Rule(s)
C.3.3 Person Responsible for Sending the Report
Sender’s
Department
Sender’s
Title
Sender’s
Given Name
Sender’s
Middle Name
Sender’s
Family Name
Data Element C.3.3.1 C.3.3.2 C.3.3.3 C.3.3.4 C.3.3.5
User Guidance The name of person in the company or agency who is responsible for the
authorisation of report dissemination. This would usually be the same person
who signs the covering memo for paper submissions.
The identification of the person responsible for sending the ICSR could be
prohibited by certain national or international confidentiality requirements.
The information should be provided when it is in conformance with
confidentiality requirements.
Business Rule(s)
Depending on the local legal requirements regarding confidentiality, it might
be necessary to omit some of the elements used to identify the person
responsible for sending the report in the transmitted message.
C.3.3.1 Sender’s Department
User Guidance This data element captures the name of the sender’s department.
Conformance Optional
Data Type 60AN
OID None
Value Allowed Free text
Business Rule(s)
See the business rules for C.3.3.
C.3.3.2 Sender’s Title
User Guidance This data element captures the sender’s title.
Conformance Optional
Data Type 50AN
OID None
Value Allowed Free text
Business Rule(s)
See the business rules for C.3.3.
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