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C.1.10.r Identification Number of the Report Which Is Linked to This Report (repeat as
necessary)
User Guidance This data element captures an identifier of another report or case that
warrants being evaluated together with this ICSR. This includes, but is not
limited to, a mother/parent-child pair where both had events/reactions,
siblings with common exposure, several reports involving the same
patient, an ICSR previously sent via paper without a conformant E2B
Worldwide Unique Case Identification Number, or several similar reports
from same reporter (cluster). The reason for the linkage between ICSRs
should be provided in H.4.
For example, if a sender wishes to reference (link) an ICSR A to ICSR B,
then the sender populates the data element C.1.10.r in both reports:
ICSR C.1.8.1 C.1.10.r
A123 cc-MAHy-A123 cc-MAHy-B456
B456 cc-MAHy-B456 cc-MAHy-A123
This data element should be populated in both ICSRs when possible,
although there are cases in which one case may not have an E2B
Worldwide Unique Case Identification Number (e.g. legacy paper report
never transmitted in ICH E2B).
Conformance Optional
Data Type 100AN
OID None
Value Allowed Free text
Business Rule(s)
C.1.11 Report Nullification /Amendment
C.1.11.1 Report Nullification /Amendment
User Guidance This data element should be used to indicate that a previously transmitted
ICSR is either considered completely void (nullified) (for example when
the whole case was found to be erroneous), or amended (for example
when, after an internal review or according to an expert opinion, some
items have been corrected, such as adverse event/reaction terms,
seriousness, seriousness criteria or causality assessment). In case of
amendment it is important to use the same ‘Sender’s (case) Safety Report
Unique Identifier’ (C1.1) and ‘Worldwide Unique Case Identification’
(C.1.8) previously submitted (See exceptions in C.1.1).If it becomes
necessary to submit a report that has been previously nullified, a new
‘Sender’s (case) Safety Report Unique Identifier’ (C.1.1) and ‘Worldwide
Unique Identifier’ (C.1.8.1) should be assigned. 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 from a primary
source.
Conformance Optional
Data Type 1N
ICH ICSR Implementation Guide 12 April 2013
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C.1.10.r Identification Number of the Report Which Is Linked to This Report (repeat as
necessary)
User Guidance This data element captures an identifier of another report or case that
warrants being evaluated together with this ICSR. This includes, but is not
limited to, a mother/parent-child pair where both had events/reactions,
siblings with common exposure, several reports involving the same
patient, an ICSR previously sent via paper without a conformant E2B
Worldwide Unique Case Identification Number, or several similar reports
from same reporter (cluster). The reason for the linkage between ICSRs
should be provided in H.4.
For example, if a sender wishes to reference (link) an ICSR A to ICSR B,
then the sender populates the data element C.1.10.r in both reports:
ICSR C.1.8.1 C.1.10.r
A123 cc-MAHy-A123 cc-MAHy-B456
B456 cc-MAHy-B456 cc-MAHy-A123
This data element should be populated in both ICSRs when possible,
although there are cases in which one case may not have an E2B
Worldwide Unique Case Identification Number (e.g. legacy paper report
never transmitted in ICH E2B).
Conformance Optional
Data Type 100AN
OID None
Value Allowed Free text
Business Rule(s)
C.1.11 Report Nullification /Amendment
C.1.11.1 Report Nullification /Amendment
User Guidance This data element should be used to indicate that a previously transmitted
ICSR is either considered completely void (nullified) (for example when
the whole case was found to be erroneous), or amended (for example
when, after an internal review or according to an expert opinion, some
items have been corrected, such as adverse event/reaction terms,
seriousness, seriousness criteria or causality assessment). In case of
amendment it is important to use the same ‘Sender’s (case) Safety Report
Unique Identifier’ (C1.1) and ‘Worldwide Unique Case Identification’
(C.1.8) previously submitted (See exceptions in C.1.1).If it becomes
necessary to submit a report that has been previously nullified, a new
‘Sender’s (case) Safety Report Unique Identifier’ (C.1.1) and ‘Worldwide
Unique Identifier’ (C.1.8.1) should be assigned. 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 from a primary
source.
Conformance Optional
Data Type 1N