# Formatting Annotated Case Report Forms (aCRFs): Part 3

**URL:** <https://forum.certara.com/t/formatting-annotated-case-report-forms-acrfs-part-3/1598>\
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**Created:** [October 9, 2020, 5:15pm UTC](https://forum.certara.com/t/formatting-annotated-case-report-forms-acrfs-part-3/1598 "2020-10-09T17:15:46Z")\
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**Author:** ![agarrett\_1](https://avatars.discourse-cdn.com/v4/letter/a/ccd318/32.png) [@agarrett\_1](https://forum.certara.com/u/agarrett_1)\
**Post date:** [October 9, 2020, 5:15pm UTC](https://forum.certara.com/t/formatting-annotated-case-report-forms-acrfs-part-3/1598/1 "2020-10-09T17:15:46Z")

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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](https://www.lexjansen.com/pharmasug/2020/DS/PharmaSUG-2020-DS-248.pdf). And please check back as we continue this series of posts!