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Annotating CRFs (Case Report Forms) is an important, but almighty task. You need to manually create annotations for every single form. Then convert your forms into PDF. That’s a lot of time and resources. But you don’t need to do it the hard way…
Once your CRF designs are created in ryze, you can easily annotate them – all in the same place. We simply use your metadata to make the annotations for you. Then just press a button to see what your CRF design looks like in PDF format. Easily make any changes. And instantly preview again until you’re done. Imagine how much time you could save, and how much more productive you could be!
And remember, if you’re building studies from your standards library, you can reuse annotations. That’s even more time saved – with no effort at all! See why you should switch to automated CRF annotations.
An annotated CRF is a blank form that contains annotations (or notes) next to each form question. Annotations show the location of data, along with related dataset names, and variable names within those datasets in the submission.
In other words, annotations describe where the data collected for each question is stored in the corresponding dataset. They show the origin of variables, and link between the fields on the form and the variables in the dataset.
Annotated CRFs are one of the mandatory deliverables for submission to the FDA for SDTM. Your SDTM annotations let the reviewer check metadata definitions, by tracing data that has come from the CRF. They also help promote standardization of data submitted in the industry.
We’re using the Formedix platform to design CDASH example CRFs for the CDISC CDASH-IG standards package. We can create, visualize, edit and approve eCRFs in the platform, then export them in ODM-XML to use in the CDISC Library and standards packages. Formedix is one of CDISC’s longest standing members. CDISC is keen to work with technology partners that help pharmaceutical organizations to adopt and keep pace with emerging CDISC standards.
Formedix has been a valuable resource and their services have added value to our platform and data management capabilities.
Making SDTM annotated CRFs can be laborious and incredibly time consuming. ryze makes it much easier to create annotated CRFs with minimal effort.
Gone are the days of manually creating annotated CRFs each time. Then having to verify that it matches the collected data. Once the data acquisition forms for your study have been defined upfront, you can add annotations in your SDTM.
Then it’s a simple push of a button to generate a regulatory compliant SDTM annotated CRF. It’s based on your original study design, so you know it’s right. That means no more rushing to manually create your annotated CRF when pulling together your submission!
When you have end-to-end standards, your data acquisition forms are aligned with your downstream datasets. When creating a study from your standards, everything comes along. Your forms, terminologies, edit checks, datasets, and the annotations that drive the annotated CRF.
In other words, once you’ve created your standard annotated CRFs, you can reuse them from study to study.
One of the main benefits of using automated annotated CRFs in ryze is that you have detailed control over your form layouts. You decide on the font, display format, placement, color and type of annotations.
Have many types of annotation?
You can design annotations for more than mapping between fields on a form to variables in a dataset. You can create annotation notes next to fields for SAS Programmers, Data Management and reviewers.
Even provide other useful information, such as indicating which fields are required or hidden. Simply tailor annotations to fit how you want to work!
Why painstakingly create manual annotations on PDF’s, one form at a time. Let ryze do it for you and save time and resources to focus elsewhere. Just switch on the plugin of your choice. Then set your annotation type, display format, and font. Next, set your SDTM annotations on each field. Now you’re now good to go! And you can easily preview what your annotations will look like, so you know they’re correct!
What about reusing annotations?
You can reuse your standards and studies – including annotations – so you don’t have to do them again! This helps you maintain consistency across studies, standards, and in your SDTM. It also reduces the margin for error.
Annotated CRFs map data that’s collected on a form to where it’s stored in the database. Creating your annotated CRFs and SDTM annotated CRFs in Formedix is quick and easy to do. Reusing your standardized forms means they’ll be of high quality and consistent across studies. They’re easy to edit and you can see what they look like as you work on them. And your bookmarks are updated automatically! Find out more about why you should switch to automating annotated CRFs.
Annotated CRFs in PDF format, named “blankcrf.pdf” is mandatory for regulatory submissions.
This is simply an annotated CRF that adheres to CDISC SDTM rules that allow for consistency and efficiency. Each SDTM annotation maps to an SDTM dataset.
Yes. You can reuse your standardized content in Formedix. That means your annotated CRFs can be reused. So you don’t need to do them again! This reduces the chance of errors, and your studies and standards will be consistent.
Yes. You can create annotation notes for different viewers as well as annotations for mapping forms to variables in a dataset.