36
ICH ICSR Implementation Guide 12 April 2013
-37-
o Date: See Appendix II (A)
o Boolean: Boolean values are represented by:
‘false’ which can also equate to ‘no’
‘true ’which can also equate to ‘yes’*
‘nullflavor’ which can have different meanings in different scenarios. HL7 refers to these
as ‘null flavors’. (See below)
*For the purposes of this IG, there is one exception to this rule for the
‘Investigational Product Blinded’(G.k.2.5) where ‘true’= ‘blinded’.
All mandatory data elements must always be part of the ICSR message, however optional
elements do not have to be transmitted. A blank optional element may not appear in the
XML code. A blank mandatory element needs to appear in the XML code for the message to
be valid.
o Some elements might need to be transmitted as part of a valid ICSR yet might need to be
empty of content for specific reasons. In HL7 messaging it is possible to transmit an
empty element and to code the element to explain the reason for the lack of data. This
allows for the creation of valid messages containing mandatory elements without
transmitting content. This reason for a blank element is referred to as the ‘flavor’ of the
null value.
o nullFlavors: ICH ICSR uses the following codes from the HL7 Messaging Standard to
categorise exceptions. For further information, please see the standard ISO /HL7 27953-
2. Not all nullFlavors are valid for all data types (e.g. PINF and NINF for non-numeric
data elements).
Code Name Definition
NI No
Information
No information whatsoever can be inferred from this
exceptional value. This is the most general exceptional value. It
is also the default exceptional value.
MSK Masked
There is information on this item available but it has not been
provided by the sender due to security, privacy or other
reasons. There could be an alternate mechanism for gaining
access to this information. Note: using this nullFlavor can
provide information considered to be a breach of
confidentiality, even though no detail data is provided. Its
primary purpose is for those circumstances where it is
necessary to inform the receiver that the information does exist
without providing any detail.
UNK Unknown A proper value is applicable, but not known.
NA Not
Applicable
No proper value is applicable in this context (e.g. last menstrual
period for a male).
ICH ICSR Implementation Guide 12 April 2013
-37-
o Date: See Appendix II (A)
o Boolean: Boolean values are represented by:
‘false’ which can also equate to ‘no’
‘true ’which can also equate to ‘yes’*
‘nullflavor’ which can have different meanings in different scenarios. HL7 refers to these
as ‘null flavors’. (See below)
*For the purposes of this IG, there is one exception to this rule for the
‘Investigational Product Blinded’(G.k.2.5) where ‘true’= ‘blinded’.
All mandatory data elements must always be part of the ICSR message, however optional
elements do not have to be transmitted. A blank optional element may not appear in the
XML code. A blank mandatory element needs to appear in the XML code for the message to
be valid.
o Some elements might need to be transmitted as part of a valid ICSR yet might need to be
empty of content for specific reasons. In HL7 messaging it is possible to transmit an
empty element and to code the element to explain the reason for the lack of data. This
allows for the creation of valid messages containing mandatory elements without
transmitting content. This reason for a blank element is referred to as the ‘flavor’ of the
null value.
o nullFlavors: ICH ICSR uses the following codes from the HL7 Messaging Standard to
categorise exceptions. For further information, please see the standard ISO /HL7 27953-
2. Not all nullFlavors are valid for all data types (e.g. PINF and NINF for non-numeric
data elements).
Code Name Definition
NI No
Information
No information whatsoever can be inferred from this
exceptional value. This is the most general exceptional value. It
is also the default exceptional value.
MSK Masked
There is information on this item available but it has not been
provided by the sender due to security, privacy or other
reasons. There could be an alternate mechanism for gaining
access to this information. Note: using this nullFlavor can
provide information considered to be a breach of
confidentiality, even though no detail data is provided. Its
primary purpose is for those circumstances where it is
necessary to inform the receiver that the information does exist
without providing any detail.
UNK Unknown A proper value is applicable, but not known.
NA Not
Applicable
No proper value is applicable in this context (e.g. last menstrual
period for a male).