Define.xml is the metadata that describes the content and formatting of submission datasets and the...
Annotated CRFs document the location in a database of the data collected for each question on a form. It is a mapping between each item on a form to its corresponding variable contained within the corresponding dataset.
Annotated CRFs are part of the mandatory CDISC submission deliverables to the FDA. So they are a must! The FDA requires submission to be in PDF format and named “blankcrf.pdf”. Their purpose is to provide traceability. They help FDA reviewers find the origin of variables in the submitted datasets.
There is a huge amount of data to be dealt with across the whole industry. So it is really important to make sure all data submitted is standardised and consistent.
The traditional process
It is common to annotate CRFs by hand in the pharmaceutical industry. It is a monotonous, time consuming manual task. And you need to keep doing it time and time again for every CRF, in every study.
Steps in the traditional process:
- Open the PDF document. For each CRF, you need to identify all annotations that need to be added. Make sure to consider all sources of data.
- Set the font and colour of your annotations. Then, place them on the page, one by one.
- Add all links and bookmarks to each CRF. Because there are so many, it is difficult to create consistent annotations. And there is no inheritance whatsoever.
- When changes occur, merge the changes into the PDF document and update the annotations.
- Redo all your bookmarks.
What if there are several rounds of changes? Steps 4 and 5, repeated again and again. You can see why it is such a time consuming, monotonous process!
So what is the solution? Automating your CRFs!
What are the benefits of automating annotated CRFs?
The benefits in a nutshell:
- Manual work and effort are reduced (and boredom alleviated!).
- It is much quicker and easier to do than a manual process.
- You get higher quality, more consistent annotations.
- You can set up a format so that the colour, position, and text is consistent.
- You can reuse your standardised annotations across different studies.
- It is easy to edit forms and annotations.
- There is no need to redo bookmarks – this is done automatically!
Fortunately, there is clinical trial automation software to help realise these benefits. And one such example is the Formedix platform.
How to do annotated CRFs in Formedix
Working with annotated CRFs in Formedix is quick and easy. You can see the streamlined processes for new and existing content in the diagram above.
For new content, simply create your forms and enter your annotations. This is straightforward to do, but it does take longer than using standardised, existing content. Then, just preview your forms and make any changes. With just 1 click of a button, publish your instant annotated CRFs.
And for existing content? Just import your forms into your study along with your metadata assets, such as edit checks and datasets. This includes your annotations. With 1 button click, preview your forms to make sure they look right.
When you are happy, it is one click to generate your SDTM compliant instant annotated CRFs.
How can Formedix clinical trial automation software help?
Formedix makes creating annotated CRFs easy. There is no programming involved. Once you have got your forms and annotations, its 1 click to get your submission ready annotated CRFs.
You can create your forms from scratch and add annotations. Or use your standardised forms – you create them once and reuse again and again!
By standardising forms you can be confident they are aligned with your downstream datasets. And you know your annotations will be consistent and of high quality, because they have been standardised.
Not only can you create annotations for mapping forms to variables in a dataset, but you can also create annotation notes for different viewers. For example, adding notes for SAS programmers, data management team members, and reviewers.
Need to edit your forms and annotations? It is quick and easy to do! And you can preview them immediately to see how your changes look.
Formedix integrates with 7 leading EDCs, including Medidata Rave and Oracle InForm. All you need to do is choose you are EDC, then set your annotation type, display format, and font. Set your annotations on each field. And when you are ready, click a button to see what your form will look like and how it will work in your chosen EDC.
There is no repetitive, time-consuming work! A few straightforward steps and you are good to go.
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