Validating Values Containing Prime Signs

n Na

on October 11, 2019

Hi,

Whenever there is a prime sign in my dataset, I will get errors, i.e.: Value for IETEST not found in (Inclusion/Exclusion Criterion) user-defined codelist

It seems that in the Pinnacle 21 report got rid of every prime sign in the Value column: i.e.: in the investigators opinion

In my dataset, it is: in the investigator's opinion

I did mask the prime sign with &#39 when creating define: in the investigator's opinion

Is there a way to fix this kind of problem?

Thanks.

Forums: Define.xml

Sergiy

on October 11, 2019

P21

It should not be a problem

Hi Na,

Utilization of the apostrophe symbol should not be an issue during validation of study data and define.xml file. Also, you do not need to use its coded representation. "in the investigator's opinion" should work. Ensure that both a SAS dataset and define.xml file use exactly the same symbols.

Look at CDISC example for SDTM data provided in their Define-XML v2.0 documentation package. EGTEST variable has a codelist which includes terms with a prime symbol. The false-positive messages are not reported during validation.

Kind Regards,

Sergiy

j Jozef

on October 12, 2019

Validating Values Containing Prime Signs

Just back from teaching a Define-XML course for CDISC ...

This kind of posts make me sad ... - I am over and over again negatively surprised how little XML knowledge people who generate Define-XML and even who develop software for generating Define-XML have.

In XML, the "prime sign" (better known as "single quote" or "apostrophe") is a special character. Reason is that it can be used to embed attribute values, though mostly the double quote is used. So if you do have a single quote in your text that goes into the XML, the safest is to replace it by its "entity", which is NOT "&#39", but which IS "'" (don't forget the semicolon at the end).
I do not know what tool you used for generating the define.xml, but essentially, the tool should take care of that.
In your case, the best way to solve this it to just edit your file (NotePad++ suffices, or use an XML editor), and replace all single quotes and/or "&#39" by the real XML entity "'".

If that does not make the error disappear, there is a bug in the validation software.

BTW, do NOT use "Microsoft" (skew) quotes, these usually lead to disaster. This e.g. sometimes happen when people start from an Excel or even Word documents for generating the define.xml.

And if you would have taken the CDISC Define-XML course, you would have learned all of this (XML and Define-XML expert in just one day ...).

Jozef Aerts
XML4Pharma