Validation Rule Suggestions

Hi all,

This rule states that:

Hi all,

The OpenCDISC tool provides validation rules with category = "Terminology" and content of the following form: "Value for $SENDCol not found in ($Codelist) CT codelist" (CT0004 -> CT1046).

Apparently the rules apply to all CT codelists, both extensible and not extensible.

And I'm not 100% sure that these rules should apply to extensible codelists - where the user is allowed to add new entries (that are not found into the standard CT codelist).

So in my opinion:

Hi all,

I'm getting the following warning for TS: "Value for TSVAL not found in (ROUTE) CT codelist".

My route value is not in the list of SEND Controlled Terms for the ROUTE CodeList, but it is added in define.xml as below:

The SDTM I.G. for 3.1.2 (and in the update for 3.1.3) has DS domain examples showing "OTHER EVENT" (dscat) records populated with the EPOCH nonnull.  See p. 108, with Other Event of dsdecod=TREATMENT UNBLINDED, dscat=OTHER EVENT and nonnull EPOCH=TREATMENT PHASE.   The example was not changed for 3.1.3. 

Other examples show EPOCH as null for dscat of PROTOCOL MILESTONE.

CDISC released in 2012 an updated final standard for the TS domain, with new variables TSVALNF, TSVALCD, TSVCDREF and TSVCDVER.  The use of TSVALNF (null flavor) allows for null values of TSVAL, which would otherwise trip a validation error.

Will the next release of OpenCDISC accommodate the updated domain standard, and remove the error flag for null TSVAL when these variables are included with a nonnull TSVALNF value?

Thank you very much.

Joan

Hi all,

Wouldn't be usefull a cross-check for ARMCD and SETCD values between DM and TX?

Currently I can have one  set of values for ARMCD/SETCD in DM.xpt and different ones in TX.xpt and no consistency error/warning is reported...

Thanks!

Hello all,

When processing a dataset that contains tumor.xpt and define.xml entries for it, the OpenCDISC Validator reports:

SD0061 - "Domain referenced in define.xml but dataset is missing": "Domains referenced in data definition document (define.xml) should be included in the submission".

The dataset contains the tumor.xpt file and define.xml references it correctly (I think):

Hello all,

I was wondering if any validation related to the content of TUMOR.XPT was implemented into the Validator.

Best regards,

Amelia

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...