Formedix does the hard stuff for you.
Formedix does the hard stuff for you.
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 takes a lot of time and resources. But you don’t need to do it the hard way…
Once your study forms are set up in Formedix, 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 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!
An annotated CRF is a blank form that contains annotations, or notes, next to each question on the form. Annotations show the location of data along with related dataset names, and variable names within those datasets, that are included 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 provide a link between the fields on the form and the variables in the dataset.
Annotated CRFs are one of the mandatory deliverables required for submission to the FDA to reflect the data submitted in SDTM. It lets the reviewer check metadata definitions by tracing data that has come from the CRF. It also helps to promote standardization of data submitted in the industry.
Formedix has been a valuable resource and their services have added value to our platform and data management capabilities. ...
CRF annotation can be a laborious, time consuming manual task which takes time and effort. Formedix makes it simple to generate annotated CRFs with minimal effort.
Gone are the days of manually creating it each time and having to verify that it matches the collected data. Once the data acquisition forms for your study have been defined up front, you can add annotations describing where the data flows to in your SDTM.
Then it’s a simple push of a button to generate a regulatory-compliant annotated CRF. It’s based on your original study design, so you know it’s right. This 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 have created your standard annotated CRFs you can reuse them from study to study.
One of the main benefits of generating annotated CRF using Formedix, 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 use 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. And you can provide other really useful information such as indicating which fields are required or hidden. You can tailor annotations to fit how you want to work!
Instead of manually creating your annotations on PDF’s, one form at a time, Formedix massively reduces the time, effort and resources required. All you need to do is switch on the plugin of your choice. Then set your annotation type, display format, and font. Next, set your SDTM annotations on each field. You’re now good to go! And you can easily preview what your annotations will look like, so you know they’re correct!
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 margin for error.
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