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C.1.5 Date of Most Recent Information for This Report
User Guidance This data element captures the date each time follow-up information is
received by the sender from a primary source. However, if the case is
amended for any other reason (e.g. after internal review by the sender) this
date should not be changed, and the data element C.1.11.1 should be
populated with the value ‘amendment,’ indicating that the case was
amended by the sender. (See the user guidance for C.1.11.1)
Conformance Required
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
Business Rule(s)
Minimum precision required is the day (i.e. ‘CCYYMMDD’).
The date specified cannot refer to a future date.
The ‘Date of Most Recent Information for this Report’ should be changed each time
follow-up information is received by the sender.
The date originally reported in C.1.5 should not be changed in an amended or
nullified report if no new information on the case has been received.
C.1.6 Additional Available Documents Held by Sender
The documents received from the primary source (e.g. clinical records, hospital records, autopsy
reports, ECG strips, chest X-ray, photographs) should be listed individually. List all the
documents held by the sender, even if they are not actually forwarded to the receiver. Literature
reference documents, when available, are described in Section C.4, and are not duplicated in
C.1.6.
C.1.6.1 Are Additional Documents Available?
User Guidance When retransmitting information, the sender (retransmitter) indicates
‘true’ in this data element only if they have the documents available.
Conformance Required
Data Type Boolean
OID None
Value Allowed false
true
Business Rule(s)
For further information on how to attach documents to an ICSR, please
see Section 3.5.
ICH ICSR Implementation Guide 12 April 2013
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C.1.5 Date of Most Recent Information for This Report
User Guidance This data element captures the date each time follow-up information is
received by the sender from a primary source. However, if the case is
amended for any other reason (e.g. after internal review by the sender) this
date should not be changed, and the data element C.1.11.1 should be
populated with the value ‘amendment,’ indicating that the case was
amended by the sender. (See the user guidance for C.1.11.1)
Conformance Required
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
Business Rule(s)
Minimum precision required is the day (i.e. ‘CCYYMMDD’).
The date specified cannot refer to a future date.
The ‘Date of Most Recent Information for this Report’ should be changed each time
follow-up information is received by the sender.
The date originally reported in C.1.5 should not be changed in an amended or
nullified report if no new information on the case has been received.
C.1.6 Additional Available Documents Held by Sender
The documents received from the primary source (e.g. clinical records, hospital records, autopsy
reports, ECG strips, chest X-ray, photographs) should be listed individually. List all the
documents held by the sender, even if they are not actually forwarded to the receiver. Literature
reference documents, when available, are described in Section C.4, and are not duplicated in
C.1.6.
C.1.6.1 Are Additional Documents Available?
User Guidance When retransmitting information, the sender (retransmitter) indicates
‘true’ in this data element only if they have the documents available.
Conformance Required
Data Type Boolean
OID None
Value Allowed false
true
Business Rule(s)
For further information on how to attach documents to an ICSR, please
see Section 3.5.