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ICH ICSR Implementation Guide 12 April 2013
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C.1 IDENTIFICATION OF THE CASE SAFETY REPORT
This section corresponds to the root of the case safety report. An ICH ICSR message file
contains one and only one ICSR an ICH ICSR batch file contains one or more ICH ICSR
messages. Therefore, there must be one and only one ‘subject’ element within
‘controlActProcess’ in the ICSR message file.

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