DD0113 Error in P21 for the SDTM Define

Sergiy

on July 22, 2019

P21

For questions related to Enterprise use its Support Resources

Hi Bianca, 

For questions related to Enterprise version, please try our P21 Enterprise support resources.

However, based on your description it sounds like you have multiple MedDRA references in your define.

Kind Regards, 

Sergiy

Hello Sergiy, Yes, that is…

Hello Sergiy,

Yes, that is the case. But when I keep only one MedDRA references in define then P21 Community shows an error for the numerical variables with dictionary saying that "Codelist/Variable Data Type mismatch". So I am bit confused. Am I supposed to have only one MedDRA references for both character and numeric variables with dictionary or not?

Thank you!

Sergiy

on July 25, 2019

P21

Yes, it's quite confusing

Hi Bianca, 

Yes, it's quite confusing.

Recommendation is to populate a reference to MedDRA dictionary only for variables of text type and skip numeric variables. They represent a coded value of paired MedDRA variable. So, formally it's enough to specify MedDRA for AEDECOD, AELLT, etc. and ignore AEPTCD, AELLTCD, etc. variables.

Based on your initial post we identified a bug which will be fixed soon. Current version of the validator assumes only a single MedDRA dictionary in define.xml. That's why you had your false-positive messages. A difference between Community and Enterprise validation results is due to different define.xml files you used for validation. They are not the same.

Thank you, 

Sergiy 

Thank you Sergiy! I will try…

Thank you Sergiy! I will try this approach.

Kind regards,

Bianca.

Lex

on July 27, 2019

Bug

Would it not be better to document a false positive in the Reviewer’s Guide, instead of avoiding an incorrect message by not specifying metadata that should be specified.

Character variables that are controlled by MedDRA should have an external codelist reference. The purpose of metadata in a submission goes beyond satisfying validation software! Letting metadata decisions be driven by validation software issues does not seem a good practice. 

Lex

Bug not fixed yet

I agree with Lex's suggestion and it is a good practice to document the false positive in the Reviewer's Guide than to adjust them in the metadata.

Having said that I'm still seeing the bug of reporting false-positive messages even today by Missing MedDRA reference on the 'AEBDSYCD' variable. in the community version

Variable, Expected Dictionary ID, Referenced Dictionary ID

AEBDSYCD, CODELISTEC2, CODELISTEI1

Dictionary ID CODELISTEC2 is for a character variable and Dictionary ID CODELISTEI1 is for a numeric variable of MedDRA controlled dictionary.

Please let me know if the bug needs to be fixed or am I using the wrong P21 version. I'm using version 3.0.2

Kaja