Validation Rule Suggestions

Hello,

SEND specs:

The parameters listed as “Yes” in the “Should Include” column should always be included in the Trial Summary dataset, in order to provide proper study definition.

There are a lot of parameters with "Should Include"="Yes" (AGEU, ROUTE, etc), but the validator does not seem to report warning / error when one of these parameters is missing from TS.xpt...

Is this a validation that will be implemented in the future?

Or the recommendation from SEND specs can be ignored?

At the validation of a dataset in which dm.xpt does not contain any AGE, AGEU, AGETXT columns, I get the following warning:

"AGEU    SE0057    SEND Expected variable not found".

Note that AGE and AGETXT are Permisible in SEND3 specs, while AGEU is Expected. Why is the tool complaining about a missing "Expected" variable?

Also... if we want to make sure that we have AGE/AGETXT and AGEU always... shouldn't complain first about the AGE? Or, if the AGE is missing, AGEU should not be required to be populated...

Hi all,

I'm having the following situation:

If I populate TFRESCAT for situations when TFSTRESC=TFORRES is empty and TFSTAT=NOT DONE, the SD0045 warning is trigerred: "Missing value for --STRESC, when --RESCAT is populated".

But TFRESCAT is a Required variable, so if I try to leave it empty, the SD0002 error  is trigerred: "NULL value in -- variable marked as Required".

I could either:

a) change optionality for TFRESCAT from Required to Permissible (as for MIRESCAT); but the SEND requirements will no longer be followed...

Hello,

This rule fires when there are unscheduled/unplanned visits in a domain and the visit is not in the TV domain. However, we would never expect unplanned visits to be in the TV domain since it only hold planned visits.

Is it possible to modify the rule so that if the VISIT contains the word "Unscheduled" the rule does not fire

Regards,

David

Rule SE0001 seems to be included in SD0007. See below:

SE0001 - "Inconsistent value for Standard Units" - Standard Units (--STRESU) variable values must be consistent for all records with same Short Name of Measurement, Test or Examination (--TESTCD) and  Specimen Type (--SPEC) variables values.

SD0007 - "Inconsistent value for Standard Units" - 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).

Hi all,

I noticed that the following rule was excluded from the latest config-send-3.0.xml from SVN:

CT0009 = "Value for DOMAIN not found in (DOMAIN) CT codelist" = "Domain Abbreviation (DOMAIN) variable values should be populated with terms found in 'Domain Abbreviation' (C66734) CDISC controlled terminology codelist".

I was wondering what was the reason for removing this rule. The rule seems legit.

When the disposition date (DSSTDTC) is specified with a precision of date/time (e.g., 2012-12-31T10:59:03) whereas the exposure end date (EXENDTC) is specified only to the date-level (e.g., 2012-12-31), rule SD0082 ("Exposure end date must be less than or equal to latest disposition date") fires.

It appears as though the processing assumes that the EXENDTC without a time specified must be 12am (e.g., 2012-12-31T00:00:00), so it will always appear as before the DSSTDTC.

I would like to request the removal of validation rule SE0063 ("SEND/dataset variable label mismatch") from the SEND 3.0 ruleset.

There is no stipulation in the SENDIG or SDTM that the SAS XPT file variables' Label field must be populated with the Variable Label from the implementation guide.  In addition, this information is redundant with what is already represented in the define.xml.

Troy Smyrnios

Would it be possible to add to each rule description in the Rules tab the corresponding WebSDM ID (e.g.  IR5136)?

Hello there,

After checking out the latest version of config-send-3.0.xml from SVN, I get the following warning: "SD1054" - "Non-recommended variable length" for variables like BWBLFL, BWFAST, BWEXCLFL, CLEXCLFL.The warning's description is: "The length of flags variables (----FL, --FAST, --OCCUR, --PRESP) is expected to be 2".

But the values for those type of variables (that are controlled by the CL.C66742.NY code list) are "Y" or null.