h Hanna
on

 

Hi,

I am just wondering what set of characters that Rule FDAC216 accepts? Does it only accept wlatin1?

Forums: SDTM

j Jozef
on February 22, 2017

I haven't looked into the source code for rule FDAC216, but ....
I do however know that principally, SAS Transport 5 (as it is still a relict of the IBM mainframe time with punchcards and so), only support ASCII-7. This excludes "special" (well according to your language and culture you may find it "special" or not) European characters like ü, ß, many scandinavian characters, not to speak about asian characters. Essentially, only those characters you will find on a US keyboard ..., or technically spoken, the first 128 ASCII symbols. See e.g. http://www.pharmasug.org/proceedings/2016/BB/PharmaSUG-2016-BB15.pdf.

Really time the FDA stops requiring SAS Transport 5 and moves to XML and to Unicode (UTF-8).
 

s Sergiy
on February 22, 2017

Hi Hanna, 

Description of SD1021 (FDAC216) check in Rules tab of validadation report says "Character values should not have leading space ' ' characters, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables."

Kind Regards,

Sergiy 

h Hanna
on February 23, 2017

Thank you for your above answers. I understand that FDAC216 checks ALL domains and only checks for leading spaces and "."

There is also FDAC214 that checks: Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM).

So FDAC214 only checks FINDINGS, TS, RELREC and SUPPQUAL. My question is; why isn't FDAC214 check applicable for ALL domains and all variables instead of just FINDINGS, TS, RELREC and SUPPQUAL?

 

s Sergiy
on February 23, 2017

Hi Hanna, 

SD1029/FDAC214 check applies only to variable which values can be used as Names and Labels of new variables during common cases of data transpose conversion.

For example, 1. attaching SUPPQUAL to parent domain as new variables 2. Conversion Vital Signs data from vertical to horizontal structure with one record representing all assessments (new variables HEIGHT (Height), TEMP (Body Temperature), etc. represent a value of VSSTRESN) for a particular timepoint. 

Applying SD1029 check to all character variable would be too harsh. For example, this business rule is not applicable to studies which utilized local international languages.

Regards, 

Sergiy

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