A traditional paper case report form in clinical trials is known as a CRF (or paper CRF). An electronic case report form (eCRF) is the same as a CRF, except that it’s electronic. Both abbreviations tend to be used interchangeably, and are also referred to as forms.
CRFs and eCRFs are used for gathering patient data during clinical trials. They play a crucial role in helping to assess the safety and efficacy of clinical products.
For a study to be successful, data collected must be correct and complete. To be correct and complete, forms must be well planned with meticulous attention to detail. They must comply with the study protocol, and record its detail. They must also comply with regulatory requirements, such as those defined by the FDA.
Good CRF Design is essential for a successful clinical trial submission and getting clinical products to the market. If you want to know more about CRFs you can read our blog post.
Well-designed forms must:
To capture data correctly, here’s some things to think about:
Clear guidance is given for each response in the form above, so there will be no unnecessary queries. The yes / no response is coded and should be coded in the same way across all forms in studies for consistency.
3 common design challenges that typically come up:
To overcome these challenges there’s a number of things that can be done.
Formedix's FREE Guide on Common CRF Design Issues & How to Solve them
That’s CRF and eCRF design covered, the next thing to look at is annotating CRFs.
Annotated CRFs are a key submission deliverable, a mandatory requirement of the FDA. 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. In other words, “each CRF should provide the variable names and coding for each CRF item included in the data tabulation datasets” as stated by the FDA guidelines.
The FDA stipulates that a set of blank annotated CRFs be submitted in a PDF document called “blankcrf.pdf”. This document helps the FDA reviewer find the origin of variables in the SDTM datasets.
It’s important to standardize forms so that stakeholders such as the investigator, data manager, biostatisticians, data entry personnel, etc. have their needs met. CRFs must be user friendly and capture consistent data, that’s clear and valid.
Standardizing CRFs means you can reuse them. That’s a huge efficiency gain. They’ve already been reviewed and approved, so they’ll be consistent, and of high quality. And, annotations don’t need to be manually done on each form. You can also reuse edit checks that normally take lots of time and resources to do. So, not only is it a huge time and resource-saving, it’s a lot less hassle!
Our clinical trial automation software lets you create forms from scratch, or upload your existing forms and store them in our clinical metadata repository. Once your forms are standardized you can quickly and easily reuse them across other standards and studies. Including annotations and edit checks. It’s easy to find, share, and update your forms. And you can preview them in different formats as you design them, as well as being able to see how they look and work, in 7 leading EDCs including Rave and InForm. CRF, EDC, and CDISC validation are built-in, so you don’t have to worry about being compliant.
Gilbert Hunter
Customer Success Manager | Formedix
Gilbert joined Formedix nearly ten years ago as a technical writer. The system knowledge he gained from content development, together with his existing customer service skills, marked him out for transition to the Professional Services (PS) team.
Gilbert has worked with the PS team for over four years, providing both CDISC-based training and software training, as well as support and consultancy services to Pharmaceutical, Biotechnology and Clinical Research Organizations. He helps organizations build studies faster and to a higher quality by making their clinical trial design and regulatory submissions far more efficient.
Today, as Customer Success Manager, Gilbert’s focus is to ensure customers maximize the benefits they can achieve from ryze by overcoming their challenges and achieving their goals.