Validation Rule Suggestions

Description

This is where folks can suggest additional rules for the Pinnacle 21 Validator.

March 20, 2013

For Version 1.4, we have new rules SD1080,1081, and 1082that check variable length and send out following messages (ERROR in case of SD1082).  "Variable length should be assigned based on actual stored data to avoid to minimize file size. Datasets should be resized to the maximum length used prior to splitting."

But is the resize really required regardless or dataset size? Should these messages be just informational or really error?

 

 

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February 25, 2013

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:

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January 30, 2013

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:

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January 24, 2013

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.

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January 21, 2013

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

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January 10, 2013

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!

 

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December 5, 2012

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):

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November 16, 2012

Hello all,

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

Best regards,

Amelia

 

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