- Why Us
The case report form (CRF) is a staple in clinical studies. These are the forms clinical investigators use to collect patient information related to an ongoing clinical investigation. There are typically two ways of recording that information: paper CRFs or electronic case report forms (eCRFs).
Although electronic data entry has been around for decades, paper CRFs continue to be used in some cases. Intuitively, you might expect that moving from paper to eCRFs would speed up data entry and lower the rate of errors.
Both studies found that the use of eCRFs in clinical studies was associated with reduced data entry errors and increased speed of study completion. They also found a preference for eCRFs among clinical investigators.
Let’s dig a little deeper into the findings and explore why eCRFs came out ahead of paper CRFs in both studies.
Both studies collected data on the differences between using eCRFs and paper CRFs in clinical investigations.
The first study, from 2014, used data from 27 different clinical studies sponsored by the Paris hospital consortium. Eleven of those studies used eCRFs and 16 used paper CRFs. The study found that:
Total cost per patient was lower using eCRFs (374€ ±351 with eCRFs vs. 1,135€ ±1,234 with paper CRFs)
Clinical studies were completed faster using eCRFs (31.7 months vs. 39.8 months; p = 0.11)
eCRFs were “globally preferred by all for easier monitoring and improved data quality”
The second study, from 2017, was conducted on top of a clinical trial at a clinical research facility. It was primarily concerned with determining whether it's faster to use eCRFs than paper CRFs. The study found that:
eCRF data collection was “associated with significant time savings across all conditions.”
Using eCRFs led to fewer errors in data entry.
Overall, “using eCRFs instead of paper CRFs increases the time efficiency of data collection in clinical trials, irrespective of item quantity or patient ages, and improves data quality.”
Increased speed and accuracy of eCRFs, along with a preference for eCRFs among stakeholders, were the major findings from the studies. Let’s talk a little about why that might be.
The reduced study time associated with eCRFs likely stems from the instantaneous access sponsors have to eCRF data. With paper CRFs, the physical forms have to be shipped somewhere and reentered in an electronic system. That builds a lag into any system that uses paper—sponsors have to wait until they get the data to do anything with it.
Speed is also related to another finding from both studies: improved data quality.
In a modern electronic data collection (EDC) system, fields will be pre-validated, meaning sponsors can set a data range for a given input. If an investigator enters a number that is outside of the data range, the system will alert them and may prevent them from moving on.
So, if a physician who has been working for the past ten hours sits down to enter patient data and mistakenly adds an extra zero to one of her entries, the electronic form will catch the mistake.
Contrast that with paper, where an extra zero stays on the case report form until it makes its way back to the sponsor to be analyzed. At that point, the error may be caught, but someone will have to spend valuable time checking to make sure it really was an error and cleaning up the data on the backend before it can be used.
That’s probably why the 2014 study found that among the clinical investigators, clinical research associates, and data managers it surveyed, eCRFs were “globally preferred by all for easier monitoring and improved data quality.”
With all the demonstrated advantages that eCRFs have over paper CRFs, why isn’t there more widespread adoption of eCRFs in MedTech clinical trials?
Part of the answer is buried in the studies we’ve already mentioned. Both were done in the mid to late 2010s. And the 2014 study reviewed clinical investigations that had been completed between 2001 and 2011. And at that time, the EDC systems that were available had a number of problems.
There were often extensive IT requirements, such as specific hardware or on-site software installation. On top of that, the user interface was not particularly user-friendly and could be frequently frustrating to clinical investigators. Half of investigators in the 2014 study reported technical problems with the eCRFs.
Additionally, a lack of portable devices meant that data might have to be written down first and then entered in an eCRF—an issue specifically called out by investigators in the 2014 study.
One investigator summed up the difficulties with the older software: “eCRFs are developed by those who use data but never by those who enter the data and who have, in the present context, less and less availability.”
Yet when asked if they would accept eCRFs in the future, 82% said yes. Just 51% said they would accept paper CRFs.
What’s clear from the responses in this study is that clinical investigators understood, even in 2014, that eCRFs offered significant advantages over paper CRFs. The problem wasn’t that they were electronic; the problem was that they were inflexible and not designed with varied use cases in mind.
As another clinical investigator in the 2014 study put it, “By trying to make money, firms that sell this type of CRF software developed templates that do not fit well with the variability of studies and data.”
Fortunately, we’re now almost a decade removed from that study, and the options for eCRFs and EDC systems in general have grown enormously. MedTech companies no longer have to rely on inflexible software that gives clinical investigators headaches.
Overall, the use of paper CRFs in clinical trials is on the way out. Some study sites will even tell sponsors up front that they need to use some type of EDC software. They won’t even accept paper at this point. Here is a step-by-step guide for how to make the transition from paper to an EDC system, without a hassle.
The problem is, most EDC solutions were built with pharmaceutical trials in mind—or they’re not industry-specific at all. These types of systems can take as long as 12 weeks for the database build and require programming rather than simple configuration.
So, MedTech companies need an electronic solution. But they also need one that’s built to handle the smaller, often unique study designs that medical device clinical trials require. And they need a solution that makes life easier for clinical investigators, not harder.
Fortunately, Greenlight Guru’s EDC platform offers all that and more.
Greenlight Guru Clinical is the leading clinical data collection toolbox, purposefully built for MedTech. With our EDC platform, you can collect and manage clinical data in pre- and post-market clinical studies, including registries, cohorts, surveys, human factor testing, design validation, and more.
Greenlight Guru also meets FDA and European regulatory requirements and ensures compliance with Good Clinical Practice and ISO 14155:2020.
If you’re ready to take advantage of a modern, flexible EDC system built specifically for MedTech, then get your free demo of Greenlight Guru today!
Jón Ingi Bergsteinsson, M.Sc. in Biomedical Engineering, is the co-founder of Greenlight Guru Clinical (formerly SMART-TRIAL). He was also the technical founder of Greenlight Guru Clinical where he paved the way for the platform’s quality standards, data security, and compliance.