c Courtney
on

 

Hi,

I am working on an extension study with over 200 visits. Most of the visits contains the same assessments, just repeated over and over again. When bookmarking and creating TOC, do we have to create a bookmark for every visit? This would also make the TOC very, very long. Could we maybe use "Visits 100-150" as the bookmark label instead of having to do each one individually?

Thank you!

Courtney

Forums: SDTM

c Courtney
on March 16, 2021

Another question about bookmarking... If we are including multiple versions of the same panel, would the bookmark labels look like this "Adverse Events v1.0" and "Adverse Events v2.0"?

Sergiy
on March 16, 2021

Hi Courtney, 

For completed CRF, you need to include all pages for all visits.

For annotated CRFs, a common practice is to include only unique CRF pages/modules. Similar for the same field on a page, common practice is to annotate/bookmark only the first/unique CRF field on the page.

Please see our blog post and recorded webinar "Best Practice for Annotated CRFs" at https://www.pinnacle21.com/blog/best-practices-annotated-crf

Kind Regards,
Sergiy 

a Ajaykrishna
on October 20, 2023

HI,

In the dual bookmarking section, should it include all CRF form names used in the study (non-unique ones as well), even though only unique Forms are kept in the annotated CRF?

Kind Regards,

Ajay

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