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Best Practices for Annotated CRFs 

Pinnacle 21
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The SDTM annotated CRF (aCRF) is a cumbersome submission document to create. It's also highly important. It visually documents how data are mapped from the CRF to SDTM. Because this is mostly a manual task, it is key to know what makes a high-quality aCRF.
In this webinar, Amy Garrett reviews published guidance from regulatory agencies and provides best practices for CRF annotations. These practices ensure your aCRF meets current regulatory requirements and the needs of internal users.

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15 сен 2024

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Комментарии : 5   
@kschadha
@kschadha 3 года назад
Thank you for a really well presented webinar. I think the Q missed was around repeated need of annotation for the repeat pages.. This of course is not needed and you can indicate a standard text such as 'see annotation page #xx" As an example you may have same exposure pages at 20 different visits. Every unique EX form needs annotation but not every form. I think FDA allows for submission of a crf booklet with unique pages, so they may not be a problem if the aCRF is created as such.
@pinnacle21llc
@pinnacle21llc 3 года назад
Khalsa, glad you enjoyed the webinar! Thank you for adding this important guidance we missed in our presentation.
@BhageerathVijay
@BhageerathVijay 2 года назад
how to deal with missing variables ?
@sarathnandha3783
@sarathnandha3783 3 года назад
Hello? Can a locked data be unlocked for what reasons?
@sarathnandha3783
@sarathnandha3783 3 года назад
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