This is the second in a series of posts where we answer questions from our recent webinar, Best Practices for Annotated CRFs. Below, we’ve summarized the regulatory expectations and our top insights.
Tables of Contents and Bookmarks
A table of contents with hyperlinks to bookmarked pages is seen in CDISC's sample aCRF (avaliable in the Define-XML v2.0 download). Both the Metadata Submission Guidelines (MSG) from CDISC and the PDF specifications from the FDA require aCRFs to have hyperlinks to bookmarked pages. The PDF specifications also require a table of contents.
More to Come
We hope these items give you a confident default for your workflow. For further reading, see our white paper. And please check back as we continue this series of posts!
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