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C.1.6.1.r Documents Held by Sender (repeat as necessary)
C.1.6.1.r.1 Documents Held by Sender
User Guidance A description of the documents held by the sender relevant to this ICSR
(e.g. clinical records, hospital records, autopsy reports, ECG strips, chest
X-ray, or photographs) should be listed individually in this data element.
Conformance Optional, but required if C.1.6.1 is ‘true’.
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)
C.1.6.1.r.2 Included Documents
User Guidance This data element contains the actual content of C.1.6.1.r.1 if the sender
chooses to send the document.
Conformance Optional
Data Type N/A
OID None
Value Allowed Media type: e.g. Application/PDF, image/jpeg, application/DICOM,
text/plain
Representation: e.g.B64
Compression: e.g. DF
Business Rule(s)
For further information on how to attach documents to an ICSR, please
see Section 3.5.
Because a receiver’s system may have particular configurations on
handling attachments, ‘Value Allowed’ is defined by each region.
C.1.7 Does This Case Fulfil the Local Criteria for an Expedited Report?
User Guidance The definition of expedited is dependent upon the sender’s local
regulatory requirements. This data element should be used by the sender
to indicate whether the case fulfils the local expedited requirements. When
the countries of the sender and receiver differ, the receiver should be
aware that this information might not be applicable to the receiver’s
country’s regulatory requirements.
Conformance Required
Data Type Boolean
OID None
Value Allowed false
true
nullFlavor: NI*
Business Rule(s)
*’nullFlavor’ is only allowed when sender is retransmitting a case that
was first received ICH E2B (R2) format, where the equivalent data
element for C.1.7 was optionally not populated in other cases, only ‘false’
or ‘true’ should be used.
ICH ICSR Implementation Guide 12 April 2013
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C.1.6.1.r Documents Held by Sender (repeat as necessary)
C.1.6.1.r.1 Documents Held by Sender
User Guidance A description of the documents held by the sender relevant to this ICSR
(e.g. clinical records, hospital records, autopsy reports, ECG strips, chest
X-ray, or photographs) should be listed individually in this data element.
Conformance Optional, but required if C.1.6.1 is ‘true’.
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)
C.1.6.1.r.2 Included Documents
User Guidance This data element contains the actual content of C.1.6.1.r.1 if the sender
chooses to send the document.
Conformance Optional
Data Type N/A
OID None
Value Allowed Media type: e.g. Application/PDF, image/jpeg, application/DICOM,
text/plain
Representation: e.g.B64
Compression: e.g. DF
Business Rule(s)
For further information on how to attach documents to an ICSR, please
see Section 3.5.
Because a receiver’s system may have particular configurations on
handling attachments, ‘Value Allowed’ is defined by each region.
C.1.7 Does This Case Fulfil the Local Criteria for an Expedited Report?
User Guidance The definition of expedited is dependent upon the sender’s local
regulatory requirements. This data element should be used by the sender
to indicate whether the case fulfils the local expedited requirements. When
the countries of the sender and receiver differ, the receiver should be
aware that this information might not be applicable to the receiver’s
country’s regulatory requirements.
Conformance Required
Data Type Boolean
OID None
Value Allowed false
true
nullFlavor: NI*
Business Rule(s)
*’nullFlavor’ is only allowed when sender is retransmitting a case that
was first received ICH E2B (R2) format, where the equivalent data
element for C.1.7 was optionally not populated in other cases, only ‘false’
or ‘true’ should be used.