--STRESU standardized result units - same value accross one domain?

Pinnacle 21 Product Suggestions Validation Rule Suggestions
1

Hi Amelia,

Yes, you are correct.

There is a rule SD0007: “Standard Units (–STRESU) must be consistent for all records with same Short Name of Measurement, Test or Examination (–TESTCD), Category (–CAT), Specimen Type (–SPEC) and Method of Test or Examination (–METHOD)”. The severity of this rule is “Error”.

Thanks,

Sergiy

2

Hi Sergyi,

Thank you for your fast reply.

Looking at config-send-3.0.xml from the released OpenCDISC Validator 1.3, I see that this rule SD0007 is enabled only for pp.xpt.

I don’t know yet about other domains, but shouln’t this rule be enabled at least for:

  • BW “Body Weights”,

  • OM “Organ Measurements”,

  • LB “Laboratory Tests Results” ?

Thanks!

3

Hi Amelia,

The SD0007 has been assigned to all Findings domains in SEND and all SDTM profiles. If you prefer to not wait for the next official release of the validator, go to our SVN site to download most recent config files:

http://svn.opencdisc.org/validator/trunk/config/

Thank you for your valuable input!

Best Regards,

Sergiy Sirichenko

4

Hello all,

SEND specs allows you to specify some numeric results (e.g. for weighings) in both “collected” and “standardized” form, where:

a) the “collected” form is “Result of the measurement or finding as originally received or collected.” (–ORRES and --ORRESU variables);

b) the “standardized” form is the “the result value for all findings or derived from ORRES in a standard format or standard units” (–STRESC, --STRESN, --STRESU variables).

SEND specs also say that the sponsor might choose the “standard unit” to be used for the standardized variables: --STRESC, --STRESN, --STRESU. And this unit should be used consistently accross each domain.

What I understand from this is that:

  • –ORRESU can have various values into the same dataset; e.g. BWORRES in BW.xpt for one study can contain both “g” and “kg” values, for distinct rows;

  • –STRESU must have the same values in the entire dataset; e.g. if BWSTRESU in BW.xpt for one study contains both “g” and “kg” values - we might have a problem, since we are not using the same unit of measure for the “standardized” result.

My questions are:

  • Is my understanding of the problem correct? Or we are not bound to use just one standardized unit for --STRESU?

  • If so - shouldn’t the validator implement such a rule?

Thanks!

Amelia