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C.4.r Literature Reference(s) (repeat as necessary)
C.4.r.1 Literature Reference(s)
User Guidance This data element should be used for literature article(s) that describe
individual case(s), but not for articles used for data analysis. Citations
should be provided in the style specified by the Vancouver Convention,
known as ‘Vancouver style’, which has been developed by the
International Committee of Medical Journal Editors. The conventional
styles, including styles for special situations, can be found in the following
reference:
International Committee of Medical Journal Editors. Uniform
requirements for manuscripts submitted to biomedical journals. N Engl J
Med 1997 336:309-15.
Conformance Optional
Data Type 500AN
OID None
Value Allowed Free text
nullFlavor: ASKU, NASK
Business Rule(s)
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
C.4.r.2 Included Documents
User Guidance This data element contains the actual content referenced in C.4.r.1 when
the sender chooses to send a copy of the literature article.
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.
ICH ICSR Implementation Guide 12 April 2013
-68-
C.4.r Literature Reference(s) (repeat as necessary)
C.4.r.1 Literature Reference(s)
User Guidance This data element should be used for literature article(s) that describe
individual case(s), but not for articles used for data analysis. Citations
should be provided in the style specified by the Vancouver Convention,
known as ‘Vancouver style’, which has been developed by the
International Committee of Medical Journal Editors. The conventional
styles, including styles for special situations, can be found in the following
reference:
International Committee of Medical Journal Editors. Uniform
requirements for manuscripts submitted to biomedical journals. N Engl J
Med 1997 336:309-15.
Conformance Optional
Data Type 500AN
OID None
Value Allowed Free text
nullFlavor: ASKU, NASK
Business Rule(s)
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
C.4.r.2 Included Documents
User Guidance This data element contains the actual content referenced in C.4.r.1 when
the sender chooses to send a copy of the literature article.
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.