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ACK.A.4 Transmission Acknowledgement Code
User Guidance This data element captures a code to inform the organisation that
submitted the ICH ICSR batch whether to (i) take no further action, (ii)
review the remainder of the acknowledgement to determine which ICSR
message(s) need further action, or (iii) re-send the entire transaction .
Conformance Required
Data Type 2A
OID None
Value Allowed AA – Application Acknowledgement Accept (message successfully
processed, no further action)
AE – Application Acknowledgment Error (error detected, error response
has additional detail, some ICSR message(s) need further action)
AR – Application Acknowledgment Reject (parsing error, no data
extracted, re-send the entire transaction)
Business Rule(s)
ACK.A.5 Batch Validation Error
User Guidance This data element provides a description of the error(s)detected in the ICH
ICSR batch XML. This data element contains an explanation for the code
triggered in ACK.A.4.
Conformance Optional
Data Type 250AN
OID None
Value Allowed Free text
Business Rule(s)
ACK.B ICH ICSR MESSAGE ACKNOWLEDGEMENT
ACK.B.r.1 ICSR Message Number
User Guidance This data element captures the number assigned to each ICH ICSR
message (each message within a batch)by the organisation that submitted
the ICH ICSR.
Conformance Required
Data Type 100AN
OID None
Value Allowed Free text
Business Rule(s)
This is the same as N.2.r.1 and C.1.1 (Sender’s (case) Safety Report
Unique Identifier).
ACK.B.r.2 Local Report Number
User Guidance This data element captures the number assigned to the ICH ICSR message
by the organisation that received the ICH ICSR.
Conformance Optional
Data Type 100AN
OID None