SDTM 3.1.3 Validation - found some errors

That CMTRT one has been

That CMTRT one has been driving me crazy.  I just can't figure out what is wrong with it.

I found some variable order issues.  In FA, FAOBJ and FATEST are in reverse order.  In TA, the order is all messed up.

 Hi Linda, Thank you for

Hi Linda, 

Thank you for reporting issues you found in validation specifications. We fixed #1 and #2. The new specs will be available for download soon.

#3 is more interesting issue. DSDY is "Model Permissible" variable. It's not listed in SDTM IG. Therefore we used labels as specified in SDTM Model instead. However, as you can see "Study Day of Visit/Collection/Exam" is too generic. It's better to use more descriptive labels based on your specific usage. E.g., "Study Day of Collection". 

I think that it could be not appropriate to specify exact labels for variables, which are not defined in SDTM IG, but can be added according SDTM Model.

We will skip non-standard SDTM IG variables from SD0063 check for now and will re-evaluate this topic later. 

Please watch for soon update of validator profiles. This week we had a very productive meeting with the FDA/PhUSE Data Validation workgroup. We are going to implement our decisions into OpenCDISC profiles as soon as possible.

Kind Regards, 

Sergiy

Thanks for reporting FAOBJ

Thanks for reporting FAOBJ order issue. It's easy fix.

A bug with CMTRT label is the real puzzle! ;) We are still working on it. 

Hi Sergiy: We will skip

Hi Sergiy:

We will skip non-standard SDTM IG variables from SD0063 check for now and will re-evaluate this topic later.

I personally would like to see a message (information will do the trick) alerting me not using generic SDTM v1.x label for non-modeled permissible variable added to a domain.

Hi Anthony,  Yes, it's the

Hi Anthony, 

Yes, it's the plan.

Thanks, 

Sergiy

 This is a response from

This is a response from OpenCDISC development team:

"It's because the label value contains commas, and the comma is the default delimiter for splitting the Terms attribute. You will need to specify a value for the Delimiter attribute in SD0063 that won't conflict with the label text, maybe Delimiter="~" or something.

Regards,

Tim"

It's fixed now. As a temporary solutions you can download the latest development version at http://svn.opencdisc.org/validator/trunk/config/

Other option is to edit your config files. Just replace SD0063 Rule definition by the following text. Note, that it's a temporary solution. Most likely, the SD0063 check will be modified in a new soon release/update. 

<val:Match ID="SD0063" Variable="LABEL" Terms="%Variable.Label%" Delimiter="~"  When="VARIABLE == '%Variables%'" Target="Metadata" Message="SDTM/dataset variable label mismatch" Description="Variable Label in the dataset should match the variable label described in SDTM. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted" Category="Metadata" Type="Warning"/>

Regards, 

Sergiy