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Define Comment Requirements
Forums: Define.xml
j
Jozef
on February 18, 2024
Define Comment Requirements
The define-xml comments are there to help the (FDA) reviewer to understand the submission.
Every reviewer is different. Regarding FDA requirements, I usually say "each reviewer is another FDA" ...
That is why pre-submission meetings are so important, you can then already provide a prototype define.xml and (even more important) a define.html (generated from the define.xml using your stylesheet), and then ask whether the reviewer would like to see more comments, less comments ...
What are the requirements/expectations when creating Define comments for each individual SDTM variable? I’m aware that derived variables require a comment, but are there any other expectations as to which variables need comments and what these comments need to contain? Also, is there anything that should not be included in the comments, for example raw dataset names and variables?