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ICH ICSR Implementation Guide 12 April 2013
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F.r.1 Test Date
User Guidance This data element captures the date of the test or procedure. Imprecise
dates can be used.
Conformance Optional, but required if F.r.2 is populated.
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
nullFlavor =UNK
Business Rule(s)
Minimum precision required is the year (i.e. ‘CCYY’).
The date specified cannot refer to a future date.
If the test date is unknown, use NullFlavor =UNK.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
F.r.2 Test Name
F.r.2.1 Test Name (free text)
F.r.2.2a MedDRA Version for Test Name
User Guidance This data element captures a free text description of the test when an
appropriate MedDRA code is unavailable.
Conformance Optional, but required if F.r.1 is populated and F.r.2.2b is not populated.
Data Type 250AN
OID None
Value Allowed Free text
Business Rule(s)
ICH ICSR Implementation Guide 12 April 2013
-109-
F.r.1 Test Date
User Guidance This data element captures the date of the test or procedure. Imprecise
dates can be used.
Conformance Optional, but required if F.r.2 is populated.
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
nullFlavor =UNK
Business Rule(s)
Minimum precision required is the year (i.e. ‘CCYY’).
The date specified cannot refer to a future date.
If the test date is unknown, use NullFlavor =UNK.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
F.r.2 Test Name
F.r.2.1 Test Name (free text)
F.r.2.2a MedDRA Version for Test Name
User Guidance This data element captures a free text description of the test when an
appropriate MedDRA code is unavailable.
Conformance Optional, but required if F.r.1 is populated and F.r.2.2b is not populated.
Data Type 250AN
OID None
Value Allowed Free text
Business Rule(s)