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Collected Origin in define.xml v2.1

e Elisa
 on February 16, 2023

 

Hi,

 

I'm writing to ask some clarification about source for define v2.1 when type is Collected.

We have some data (in this case protocol deviations) collected outside the CRF, but it is not collected by a vendor so we were trying to use source=Subject. In this case when we generate define.xml we automatically get the link to the CRF with the error "Missing Pages value", but data is not collected from CRF so we can't really insert a page linking to the CRF here.

I also understand Sponsor is not a valid source value when type is Collected from reading define v2.1 specification document, so we are now in doubt of what the correct combination of type&source values is.

Would you have any recommendation to solve this please?

 

Many Thanks,

Elisa

Forums: Define.xml

j Jozef
on February 16, 2023

In 2.1 "Collected" is not tied to CRF anymore. So the message "Missing page values" is a a severe bug in the software that you are using.

e Elisa
on February 17, 2023

Hi Jozef,

 

Thanks for your reply. I'm using Pinnacle 21 Community Version 4.0.1, the one that is currently in download page of the website.

Is it possible that the bug is related to the value of source entered more than the origin "collected", because from a test I did still using Collected but with source=Vendor, I don't get the link to CRF and I also don't get the message about missing page, as expected and as I was expecting from using the combination Collected&Subject.

Also, just to understand better as you only replied about the validation part, could you also clarify the part of having the CRF link created automatically when using source=subject? I thought we were not supposed to have this link given the source is not CRF (Investigator).

 

Thanks again and kind regards,

Elisa

j Jozef
on February 20, 2023

Dear Elisa,
As I am currently traveling, I have no access to the Define-XML 2.1 specification, but if I remember well, there is nothing saying anything about that when Source=Investigator, there must be CRF pages. Reason is also that e.g. SEND usually does not CRFs even when the source is the investigator.
So I think (but I can check when I back) that this is an over-interpretation (once again) of the standard.

Regarding your second question, I can't say, as I am not using the mentioned software to generate define.xml files. In most cases, I generate the define.xml upfront, i.e. before the study starts, using modern tools that use XML templates for each standard and version, and use user-friendly drag-and-drop and wizards. That software is also properly documented, with a large number of user manuals and tutorials. If you want to know more, please contact me by e-mail (my address is easy to find).
Essentially, for my work, I don't want to use software that is not extremely well documented, or starts from Excel spreadsheets.

With best regards,
Jozef
CDISC Define-XML Development Team

Lex
on February 20, 2023

The rule in the Define-XML 2.1 specification section 5.3.12.3 states: When def:Origin/@Type="Collected" and def:Origin/@Source in ("Investigator", "Subject"), there must be a def:DocumentRef child element; in addition, def:DocumentRef/@leafID must match the ID attribute of a def:leaf element corresponding to the annotated CRF document.

j Jozef
on February 21, 2023

Thank you Lex! So I was wrong ...
How would this work with SEND? Would they have to make some artificial "aCRF"? Or do they use something else for "Source"?

e Elisa
on February 23, 2023

Thank you both for your help and thanks Lex for pointing me to that section, I had missed it focusing more on section 4.3.2.

Not sure you can help with my question related to how excel spec (the ones used as input to create the define with pinnacle application) should be populated for my scenario.

We collect protocol deviations from a separate file, not using CRF as the rest of the domains in our study, so I'm populating origin with Collected/Subject and pointing to the protocol deviation file we have by populating documents and pages columns. I can see a link to it has been created in the comment section of define, however I'm still getting automatically a link to the CRF, which I don't need as that is not the source of variables in DV domain, and still getting "Missing pages value" message in the report.

Would you know if there is a way to solve this?

 

Many Thanks and Regards,

Elisa

j Jozef
on February 24, 2023

About the Excel specs ...
This is a question that should be answered by P21 people (I am not). I am NEVER using Excel specs for define.xml generation as I consider this as bad practice. There are quite a number of vendors that have (relative low-cost) offerings that have much more user-friendly tools for generating define.xml files and that are not based on Excel (has your Excel been validated by the way?)
As Lex is working for CDISC, which is vendor-neutral, ....

e Elisa
on March 8, 2023

Thanks Jozef,

 

Unfortunately the choice of the tool is not up to me.

However, after a bit of reading and researches, I've found the answer and the fix to our scenario in the SDTM Submission Guidelines file found on CDISC website.

If I'm interpreting it correctly, it seems that I can append the annotated deviation form to our "main" crf file and like this is ok to have the automatic link to acrf file, which contains main CRF plus deviation form, with the link to the relevant/correct pages.

 

Many Thanks and regards,

Elisa

u Uma Devi
on March 15, 2023

Hi,

In SDTM define.xlsx specs I choose origin as collected.  Added source in the source column as dataset variable, page numbers to Pages column. when I generate define.xml using Community version there were no links to annotated CRF. Showing as Collected (Source: AE.AESTDTC) but no links to annotated CRF page. I tried origin as CRF then Showing as CRF (Source: AE.AESTDTC) again no hyperlinks to annotated CRF pages. 

when I used origin as CRF and provided page numbers to Pages column. Generated define.xml using 2-0 then hyperlinking to annotated CRF pages.

Could please help me to add hyperlinks to annotated CRF in define 2-1-0.

Thank you,

Uma. 

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