This is the third in a series of posts where we answer questions from our recent webinar. Below, we’ve summarized the regulatory expectations and our top insights.
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.
- If Version 1 had variables used to collect data, but Version 2 renamed those variables, then submit both versions.
Repeated or Similar Pages
When a CRF has many repeated pages, such as the Inclusion/Exclusion information being collected on multiple visits, you still need to annotate and submit only the unique forms.
- If you choose to include duplicate forms, have the bookmarks take you to the first, annotated instance of the repeated page.
- If your bookmarks are correct, you don’t need to annotate the repeated pages with “See annotations on page XX.” Proper bookmarking can spare you from manually making thousands of such annotations.
When forms are similar (meaning, almost but not completely identical), you need to fully annotate and submit both.
- This requirement applies to repeated pages that have minor differences, such as two added fields.
- If the differences are simply a difference in study stages, you may be able to denote the study stage with a note.
Multiple Pages for One Form
Generally, you need domain annotations only on the first page of a form. But when a form maps to multiple domains or has domains spanning multiple pages, then domain annotations on each page give added clarity.
- For example, if Page 1 of a form has variables mapped to both DM and DS domains, but Page 2 has variables mapped only to DS, then annotate both DM and DS on the Page 1 but only DS on Page 2.
Number of aCRFs
Include only one aCRF in the define.xml.
- The aCRF should consist of all unique forms across versions.
- File naming conventions for multiple aCRFs do not exist, because one and only one aCRF is permitted.
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!