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ICH ICSR Implementation Guide 12 April 2013
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C.2.r PRIMARY SOURCE(S) OF INFORMATION (REPEAT AS NECESSARY)
The primary source of the information is the person who provides the facts about the ICSR. In
case of multiple sources, the ‘Primary Source for Regulatory Purposes’ (C.2.r.5) is the person
who first reported the facts to the sender. The primary source should be distinguished from
senders and retransmitters the latter is captured in Section C.3.
Reporter’s
Name
Reporter’s
Address and
Telephone
Reporter’s
Country
Code
Qualification
Primary
Source for
Regulatory
Purposes
Data Element
C.2.r.1.1
C.2.r.1.2
C.2.r.1.3
C.2.r.1.4
C.2.r.2.1
C.2.r.2.2
C.2.r.2.3
C.2.r.2.4
C.2.r.2.5
C.2.r.2.6
C.2.r.2.7
C.2.r.3 C.2.r.4 C.2.r.5
User Guidance The identification of the reporter (primary source) could be prohibited by
certain national or regional confidentiality requirements. The information
should be provided when it is in conformance with confidentiality
requirements.
However, at least one subsection for each Primary Source should be
completed to ensure that it is an identifiable reporter.
If only the name of the reporter is known and confidentiality requirements
prohibit transmission of the reporter’s full name or initials, the data elements
C.2.r.1.2, C.2.r.1.3, and/or C.2.r.1.4 can be masked and ‘populated’ with a
nullFlavor as appropriate, in compliance with confidentiality requirements or
reporter request. Please see Section 3.3.6 for further guidance on the use of