Author: Gilbert Hunter
Creating good quality annotated case report forms (CRFs) takes time and attention to detail. While it can feel overwhelming, it shouldn’t stop you. Annotated CRFs (aCRFs) are a mandatory requirement of the Food and Drug Administration (FDA), and therefore a key submission deliverable for any clinical trial.
So, it’s important to understand what regulatory and industry guidelines are out there, to ensure your clinical trial meets the requirements.
What is an annotated CRF?
Each form in a study contains markings or annotations. These annotations map data points on forms to the name of datasets, and variables within those datasets. According to the FDA guidelines, “each CRF should provide the variable names and coding for each CRF item included in the data tabulation datasets”. Read everything you need to know about CRFs or find out what to consider when working with CRFs in clinical trials.
Below is an example of an annotated CRF that adheres to regulatory and industry requirements.
So how do you achieve submission-ready aCRFs?
There are two documents published by the Food and Drug Administration (FDA) that include requirements applicable to annotated CRFs.
We’ve highlighted some key points from both documents below. We recommend that you download and review each PDF thoroughly, to ensure adherence to requirements.
FDA’s study data technical conformance guide section 22.214.171.124 lays out guidance for providing regulatory submissions electronically, as follows:
FDA’s portable document format (PDF) specifications guide; as the annotated CRF is a PDF, it is subject to the specifications in this document.
The following technical requirements are applicable to the formatting of annotations on CRFs – this list includes some key requirements, but is not exhaustive. Review the PDF download for a full list of technical requirements for submitted PDFs, including guidelines for page layout and document navigation.
In addition to the regulatory requirements for annotated CRFs, you should also be aware of industry requirements from the Clinical Data Interchange Standards Consortium (CDISC).
These are laid out in the following documents:
Below, we’ve summarised some key points as recommended by these documents. We do advise that you review the PDF downloads, which contain detailed guidance.
Automating annotated CRFs
With traditional, manual annotated CRFs, you can spend a lot of time and effort:
This traditional process is not only time consuming; it can result in human error and a reduction in quality of your annotations.
If you find this is the case for your current process, why not consider automating annotated CRFs to make the job a little easier?
The benefits of automating annotated CRFs:
Annotated CRFs in ryze
With ryze, our all-in-one, cloud-based clinical metadata repository, you can automate annotated CRFs to save time and increase efficiencies, while ensuring that you stay compliant with industry and regulatory standards.