Annotated CRF

This is the fourth in a series of posts where we answer questions from our recent webinar. Below, we’ve summarized the regulatory expectations and our top insights.

Not Submitted Annotations

For any information that is on the CRF but not mapped to SDTM, annotate the page and/or field with "NOT SUBMITTED."

Versions and Revisions

You need to annotate and submit only the unique forms from the final version of the CRF, provided that they cover all the collected data. Combine all unique pages, e.g., those for clinical data and central review data, into a single acrf.pdf. Here are some example scenarios:

• If Version 1 had pages not used to collect data, and Version 2 removed those pages, then submit only Version 2.
• If Version 1 had pages used to collect data, but Version 2 removed those pages, then submit both versions.

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.

Intro to aCRF Formatting

"How should I best format the annotations on my CRFs?" We get that a lot. The requirements may feel murky. Users often mimic CDISC’s sample aCRF (in the Define-XML v2.0 download). But even then, you might lack confidence on the specific formatting details, and wonder how to fit your content into the usable space.

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.