Annotated CRF

Formatting Annotated Case Report Forms (aCRFs): Part 3

October 9, 2020

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.

Formatting Annotated Case Report Forms (aCRFs): Part 2

September 10, 2020

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.

Best Practices for Annotated CRFs

August 4, 2020

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.