a amparo



We noticed there is an updated to engine FDA (2010.1) in Pinnacle 21 Community, since that some of our datasets are detected issue SD1149. According to the description if the column contain null values a comment must be included in the define.xml to state. May I know how to state a comment in the define.xml? At Spec file, which tabs should describe comment, Variables tab or Comments tab? and what kind of information should be mention? (i.e. there is no value at this column...)

Thank you and best regards,


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on April 13, 2021

Hi Amparo, 

First, you need to create your comments in "Comments" tab. Then use ID from this tab for Comment column in other tabs (e.g., Variables, Dataset, Value Level) as a link to your comment.

My general recommendation for Community users is to utilize sample define.xml file included into CDISC Define-XML v2.0 standard documentation package. You can generate excel specs for this file (Community -> Define.xml -> Create Spec -> Import Define.xml) and use them as an example. 

Kind Regards,

a amparo
on April 13, 2021

Hi Sergiy,

Thank you for the recommendation!

By using excel specs, should we also make Comment ID at variables tab (please find the snapshot) first?

Then fill in column ID and column Description at Comment tab, for Document and Pages columns they are not necessary to fill out.


Thank you again


on April 14, 2021

Yes, this is correct. 

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