How can I get rid of the extra () at the end of each element in the Value Level Metadata

extra () at the end of each QNAM

Is it in the "view" only (i.e. the HTML), or also in the source XML? => please inspect the XML (you can easily do so using e.g. NotePad++).

If it is in the "view" only, you might want to adapt the stylesheet (define.xsl).

Please remember that define.xml is essentially for machines to be read (machine-machine communication), but even the FDA reviewers only use the "view".

Description

You will need to make sure that your ItemDef has a Description child element. Since SUPP-- datasets are really describing variables, they need full metadata.

Also, check out updated stylsheets at https://wiki.cdisc.org/display/PUB/Stylesheet+Library

Where column parenthesis

It sounds like you need to populate your Codelist tab of your P21 spec with the supplemental QNAM where the Term is set to your QNAM values and Decode is set to the values of the respective QLABEL. Those extra parenthesis are there because the where column generally puts the decode next to the thing you define. For instance, if you used VSTESTCD to identify the derivation for BMI in your ValueLevel tab then your WhereClause tab will have a row like

VS.VSTESTCD.BMI    VS     VSTESTCD    EQ     BMI

Under Codelists tab you should have a related row that identifies the term for VSTESTCD as BMI and the decode as Body Mass Index. So when the define is populated for VSSTRESC valuelevel metadata, the where column will display "VSTESTCD EQ BMI (Body Mass Index)" in which its just populating the extra information you supplied in your codelists.

I'm not sure that you can remove those parenthesis otherwise unless you go in after P21 creates the define.xml and edit the actual XML itself. I prefer to stay out of the XML code myself.

() issue for QVAL in SUPP-- domains

We have created the define.xml using Pinnacle21 and we get same issue.

We tried adding codelist for SUPP-- QVAL observation and it worked very well in Stylesheet version: 2013-04-24 and properly showing the labels without extra (). However in Stylesheet version: 2015-01-16 it does not worked, it shows label in () and again shows extra ().

We have used the same define.xml file to view with two different stylesheets.

In Stylesheet version: 2013-04-24, it showing like this - 

QNAM EQ AESLDS (TIME SINCE LAST DOSE)

In Stylesheet version: 2015-01-16, it showing like this - 

QNAM = "AESLDS" (TIME SINCE LAST DOSE) ()

Looks like something we need to edit in stylesheet.

Description

As mentioned, you will need to make sure that your ItemDef in the Value Level Metadata (for QNAM EQ AESLDS ) has a Description child element. Since SUPP-- datasets are really describing variables, they NEED full metadata. The CodeList with decodes is not needed for this.

The problem in the 2013 stylesheet was that it did not show the description for SuppQual variables.

Lex Jansen

CDISC Define-XML Dev team

PS: a new stylesheet is being developed in a PhUSE team.

() issue for QVAL in SUPP-- domains

@ssinojia,

The underlying problem is that people completely trust "black box" software and never inspect the real result, i.e. the generated XML itself. They just look at the VIEW of it (transformed by the stylesheet) in the browser. If you have such an issue, the first think you should always do is to inspect the XML, you can even use NotePad++ for that.

() issue for QVAL in SUPP-- domains

Thanks Lex & Jozef for your quick guidance.

Codelist is not needed or not the proper solution for this case. Most people use the Pinnacle21's method for generating define file. So where this description of variable should be included in Excel specification (which sheet) ?

OR Is it that Pinnacle21's Excel specs does not have the field for the description of variable (which act as child element) for SUPP-- domains. So once we create the define file from Pinnacle21 and then we need to add the description (child element) in XML file manually.

I know people should learn XML and inspect it, that is the best way. But in real world not every one is used to XML and other language. Take simple example of VIEW, most of the organizations have separate department to review the submission things before submission happens, those people will not inspect the define XML file. They will only see it using stylesheet in browser and check it for review.

Pinnacle21 has done great job to create define file using the Excel and which is very familiar with anybody. 

Thanks again.!

() issue for QVAL in SUPP-- domains

@ssinojia

I teach the basics of XML (sufficient to understand the define.xml structure) in less than 2 hours to my undergraduate students. So it is not that difficult! There also is a 1-day define-XML training course by CDISC. After taking that course, participants are almost Define-XML experts (everything is relative). So you should definitely send all your people that have to do with define.xml (also from other departments) to such a Define-XML course. It can even be organized to take place at your site. See https://www.cdisc.org/education/course/define-xml for more information. If the colleagues that review things before submission keep refusing to inspect the XML itself, I am afraid that will one day or another lead to a submission disaster.

Regarding creating the define.xml, and which fields to populate how and where, please contact me using my private e-mail address. You can easily find it on the internet.

Best regards,

Jozef Aerts
XML4Pharma

() issue for QVAL in SUPP-- domains

Thanks Jozef, I was expecting similar kind of response from you when I wrote about XML language. 

I can learn it (believe me I am learning too) but I can't make everyone agree to learn a language and specially those who are not in my control.

I think we have deviated from the point of Pinnacle21. there should be one field in Excel specification which turns as child element (as description) in SUPP domains. I would expect that someone from Pinnacle21 team should provide this information.