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D.1 Patient (name or initials)
User Guidance It is important that this data element is populated. The identification of the
patient might be prohibited by certain national confidentiality laws or
directives. The information should be provided when it is in conformance
with the confidentiality requirements.
Conformance Required
Data Type 60AN
OID None
Value Allowed Free text
nullFlavor: MSK
Business Rule(s)
If the initials are known to the sender but cannot be transmitted due to data
privacy requirements, this data element should be left blank with
nullFlavor =MSK.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (if
allowable)
Record numbers can include the health professional record(s) number(s), hospital record(s)
number(s), or patient/subject identification number in a study. The most appropriate data
element should be used in order to indicate the source of the number and facilitate record
retrieval when possible and desirable.
The patient identification in a clinical trial can be transmitted below in the ‘Patient Medical
Record Number(s) and Source(s) of the Record Number (Investigation
number)’(D.1.1.4).Multiple elements should be extracted from the source database, like Centre
ID, Patient ID and a random (check) number, and concatenated in this element to assure a
unique patient identification.
D.1.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (GP
Medical Record Number)
User Guidance See Section D.1.1.
Conformance Optional
Data Type 20AN
OID 2.16.840.1.113883.3.989.2.1.1.4and 2.16.840.1.113883.3.989.2.1.3.7
Value Allowed Free text
nullFlavor: MSK
Business Rule(s)
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
The following notation will be used to represent D.1.1.1:
id extension="medical record number"
root="2.16.840.1.113883.3.989.2.1.3.7"/
code code="gpmrn"codeSystem="2.16.840.1.113883.3.989.2.1.1.4"/
ICH ICSR Implementation Guide 12 April 2013
-76-
D.1 Patient (name or initials)
User Guidance It is important that this data element is populated. The identification of the
patient might be prohibited by certain national confidentiality laws or
directives. The information should be provided when it is in conformance
with the confidentiality requirements.
Conformance Required
Data Type 60AN
OID None
Value Allowed Free text
nullFlavor: MSK
Business Rule(s)
If the initials are known to the sender but cannot be transmitted due to data
privacy requirements, this data element should be left blank with
nullFlavor =MSK.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (if
allowable)
Record numbers can include the health professional record(s) number(s), hospital record(s)
number(s), or patient/subject identification number in a study. The most appropriate data
element should be used in order to indicate the source of the number and facilitate record
retrieval when possible and desirable.
The patient identification in a clinical trial can be transmitted below in the ‘Patient Medical
Record Number(s) and Source(s) of the Record Number (Investigation
number)’(D.1.1.4).Multiple elements should be extracted from the source database, like Centre
ID, Patient ID and a random (check) number, and concatenated in this element to assure a
unique patient identification.
D.1.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (GP
Medical Record Number)
User Guidance See Section D.1.1.
Conformance Optional
Data Type 20AN
OID 2.16.840.1.113883.3.989.2.1.1.4and 2.16.840.1.113883.3.989.2.1.3.7
Value Allowed Free text
nullFlavor: MSK
Business Rule(s)
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
The following notation will be used to represent D.1.1.1:
id extension="medical record number"
root="2.16.840.1.113883.3.989.2.1.3.7"/
code code="gpmrn"codeSystem="2.16.840.1.113883.3.989.2.1.1.4"/