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ICH ICSR Implementation Guide 12 April 2013
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blocks).Relationships between elements vary, as indicated by:
1 ...1 (unique and mandatory)
0 ...1 (unique and optional)
1 ...n (one to many and mandatory) or
0 ...n (one to many and optional).
Diagrams in Section 3.4 provide the next level of detail and are intended to help business users
understand how the various portions of the ICSR relate to one another, while helping
application developers understand how to populate an XML message designed and developed to
meet the E2B(R3) specification.
Figure 1: The ICH ICSR Structure
ICH ICSR Implementation Guide 12 April 2013
-22-
blocks).Relationships between elements vary, as indicated by:
1 ...1 (unique and mandatory)
0 ...1 (unique and optional)
1 ...n (one to many and mandatory) or
0 ...n (one to many and optional).
Diagrams in Section 3.4 provide the next level of detail and are intended to help business users
understand how the various portions of the ICSR relate to one another, while helping
application developers understand how to populate an XML message designed and developed to
meet the E2B(R3) specification.
Figure 1: The ICH ICSR Structure