If you need an electronic CRF for your clinical study, you can contact us at info@klindat.com
We live in the age of digital transformation, which is having a profound impact on all sectors of industry globally.
The work tools used in clinical research are no exception in this new technological era, and in recent years multiple web-based software applications have emerged that are improving the efficiency of processes in clinical trials and observational studies.
Although several software products have appeared in the field of clinical trials, a particularly important one is the electronic Case Report Form (electronic CRF or eCRF), which can be defined as an application used to manage the data of patients participating in a clinical trial or observational study.
However, as we know, clinical research projects have not always been managed with digital tools, as they were carried out for many years using physical paper.
As a matter of fact, today many clinical trial sponsors still use paper and manual means to implement data collection forms in their research.
In actuality, moving from paper to new electronic data collection platforms can be challenging at first, and clinical trial sponsors may have questions about how to make this transition.
Is it worth making the leap from paper to electronic CRFs? Are electronic CRFs really cheaper? Isn’t it very complicated to set up, maintain, and use an eCRF?
In this article, we will look at these and other questions, and provide some useful tips for clinical trial sponsors who are thinking of going paperless and starting to use CRF software.
What Is an Electronic CRF?
An electronic CRF (Case Report Form) is a web-based software application used to collect, clean, and export data in a clinical study.
Electronic CRFs are widely used in both clinical trials —interventional studies— and observational studies. They are also useful for creating patient registries or databases.
Over the last decade, eCRFs have rapidly replaced paper-based CRFs, which were typically created by printing on carbonless paper (a double-sheet paper, which is written with a pen on the first layer and marked on the second).
Unfortunately, paper CRFs have quite a few practical and efficiency drawbacks, which have been definitively solved by the new web-based CRFs.
What Are the Disadvantages of Paper-Based CRFs and How Can They Be Solved with an eCRF?
In the following lines, we will summarize the drawbacks of paper-based CRFs and explain how electronic CRFs have improved the efficiency of data management in clinical trials.
- Physical shipments of paper forms. Paper CRFs force clinical trial sponsors to make multiple physical shipments of paper forms to hospitals (and from hospitals to their offices). This requires considerable manual effort and drastically reduces the efficiency of data management processes.
- Delays in data access. Paper-based CRFs delay access to data by the sponsor. When hospital research teams fill out paper forms, this information is not immediately accessible for review. The sponsor will have to wait for the forms to be sent by courier service and will not be able to review them until they arrive at their office.
- Manual writing of data. Using a paper CRF entails the inconvenience of having to write all data by hand with a pen. This manual method is considered rudimentary and affects the quality and traceability of the data because, for example, rectifications must be made by crossing out.
- General control of the forms. The physical shipment of forms is a major difficulty when a clinical trial involves the participation of many hospitals and patients (the complexity is multiplied if we are talking about an international study with several countries). The effort required just to check the packages and keep the documentation in order can be enormous in large studies.
- Security risks. The physical mailing of forms containing patient health data carries significant security risks. Physical shipments of documents can be lost or intercepted, and can get into unauthorized hands.
eCRFs solve the aforementioned drawbacks in a powerful way:
- They totally eliminate the need for physical form submissions.
- Allow instant access to data through a web browser.
- Enable clear and traceable rectification of the information.
- Simplify data control even in multinational studies with many hospitals and patients.
- Reduce security risks as CRF web applications contain advanced data protection mechanisms.
Are Electronic CRFs Really Cheaper?
Having discussed the practical benefits of electronic CRFs, some people may wonder whether these digital systems actually reduce costs in clinical trials. Is an eCRF really cheaper than a paper CRF?
It should be said that electronic CRFs also come at a cost. More specifically, web-based CRF systems have an initial set-up fee and then usually a monthly hosting and licensing fee.
In addition, the cost of an eCRF is not only related to the software as such, as there is also the cost of the associated data management services (for which qualified professionals are needed).
For instance, it is necessary to have a data manager to build the eCRF and then to review and debug the information (although the latter is also needed in the case of a paper-based CRF).
In any case, some studies indicate that electronic CRFs are indeed cheaper than their paper counterparts.
This can be seen in the articles below:
- Electronic versus paper-based data collection for conducting health-care research: a cost-comparison analysis
- Comparison of paper-based and electronic data collection process in clinical trials: costs simulation study
In the second article shown above, Ivan Pavlovic et al. conclude that eCRFs can bring cost savings of 49 to 62% compared to traditional paper-based methods.
Isn’t It Too Complicated to Set Up and Manage an eCRF?
Some clinical trial sponsors —who have not yet made the move to electronic CRFs— are likely to see this transition as very difficult challenge.
It is only natural that the unknown causes uncertainty, so it may be useful to mention some recommendations for adopting an eCRF with confidence and certainty.
Here are some tips on how to get started with an electronic CRF with the best guarantees:
- Get expert advice. Clinical trial sponsors that are unfamiliar with electronic CRFs can obtain specialized advice from companies that are experts in eCRF solutions. A good option is to talk to one —or preferably more than one— Clinical Research Organization (CRO), as these companies have a great deal of experience in the area of eCRFs in different types of clinical trials.
- Know your technical needs. It is very important to understand that there are different kinds of electronic CRFs on the market —with different price points— so each sponsor should be aware of what type of eCRF best suits their specific needs. Why pay more for one system when a simpler, cheaper system is enough for a specific clinical study?
- Specify well the data you need in your study. Clinical trial success —and successful adoption of an electronic CRF— starts with being clear about what data you need in your research. It is extremely important for a sponsor to know what data are critical to meet the objectives of their study, so that the eCRF can be designed and used with the utmost accuracy and efficiency.
Conclusion
Is it worth switching from a paper CRF to an electronic CRF? The short answer is yes. The reality is that there are very good technical and economic reasons to use an eCRF and leave paper behind. The obvious benefits of new Internet-based technologies are also evident in clinical trial data management. Without a doubt, web-based CRFs are the way forward as the benefits are many and quickly apparent.
If you need an electronic CRF for your clinical study, you can contact us at info@klindat.com