Here are some practical guidelines to selecting an EDC system. Some basic blocking and tackling. Always good.
EDC not paper
Electronic data capture (EDC) systems are basically the standard for clinical trial data management.
To put it simply, the old-school process of using a paper case report form (CRF) and then uploading it into an online database is needlessly inefficient, being that cloud-based services, such as EDC, are becoming the standard for data collection and storage. Data collected in a study can now be directly electronically entered into a desktop, laptop, tablet, even a smartphone.
Best practices for implementing EDC
It seems to us that its still taking some time until project managers and clinicians are familiar with the proper implementation of an EDC system, and time for software developers to streamline their software for rapid onboarding during its implementation.
Perhaps the project manager has failed to address required operational changes when switching to EDC from a paper-based data collection system. Or, maybe they simply choose an improper EDC system for the study they are planning to conduct. Whatever the reason, choosing the appropriate EDC for your clinical trial studies is necessary in order for this technology to be as effective as it was designed to be.
That being said, the EDC industry is gaining traction in the clinical trial market, not because it is “green” technology (bye-bye, paper!), but because when used in proper practice, it boosts a study’s efficiency (cloud-based data can be collected, monitored, and edited anytime/anywhere) and significantly cuts study costs, among other benefits.
The 2011 article Comparison of Electronic Data Capture (EDC) with the Standard Data Capture Method for Clinical Trial Data – 8 years ago today, talks about the advantages of EDC versus paper.
In the above study, the use of EDC is a smarter way to capture data, and results in fewer mistakes than paper-based methods. If you are still on the fence of whether or not to incorporate EDC into your clinical trials, take into account the basic benefits of EDC:
– Cost savings through enhanced efficiency
– Improved data accuracy & organisation
– Decrease in compliance errors
– Greater data security
– Availability of remote study data access
– Outsourcing potential to further reduce costs
If you are not intimately familiar with EDC, or are looking for a new EDC system vendor, let us go over some of the considerations you should be making when you are hunting down the ideal EDC system to use in your clinical trial(s) data capture and management. There are literally several dozen EDC vendors as of today, so these tips will help you identify which vendor will suit your study.
Before shopping for a vendor, first identify the specific factors and parameters your clinical trial is going to be researching and measuring. Some studies are short-term, and may only be measuring, for example, a drug’s impact on a participant’s weight. Other trials may be much more intensive, studying hundreds of patients and dozens of variables and parameters.
When looking for your ideal EDC system, account for necessity. There is no need to waste study funds on a well-known, but costly and complex EDC system if your next clinical trial does not warrant such a product.
2. Ease of use
This may seem like a no-brainer, but in line with necessity, EDC software comes in all shapes and sizes of various degrees of complexity, so to suit every imaginable clinical trial, EDC systems can be rather complicated. However, despite complexity, an intuitive user interface will lessen the time spent on on-boarding your team to learn how to effectively navigate the EDC.
It is essential that your EDC system be simple to understand for every person authorized to use it, including monitors, project managers, data managers, even patients if your study involves patient submitted data (another clinical trial component facilitated by using EDC).
When vetting vendors, do not simply rely on reviews and online testimonials. Ask the vendor for a trial run of their EDC offerings, and make certain that it not only suits your needs, but is also easily navigable.
3. FDA compliance
This only applies to clinical trials that gather and deliver data to the FDA, but since many do, it needs to be covered. If your company fits into this category, it is imperative that the EDC you are considering meets the FDA’s 21 CFR Part 11 regulations.
Do not simply take the vendor’s word for it, but research whether it in fact meets current standards, that their software is not outdated, and that there are tools in the software to rapidly make adjustments to any future changes in compliance standards. In the case of compliance, it is the vendor’s responsibility to ensure that the software meets 21 CFR, but it is the sponsor’s responsibility to ask in the first place.
4. Timeline for setup and implementation
Remember how EDC cuts study costs and enhances efficiency? That is only true if it does not take a lifetime for your system to get up and running. After you have addressed the preceding considerations, be direct with your vendor. Tell them how much time you have planned for to implement an EDC system for your upcoming clinical trial, and ask whether there system will be able to accommodate your timeline.
5. User training resources
One consideration that is all too easy to forget, is to inquire into the training and help desk provisions the EDC vendor has. Looking into these issues:
-Do they have an EDC training program beyond a user manual for their hardware/software?
-Is the training free, or does it require a fee?
-How quickly is the sponsor, in fact, every user, able to get in touch with the help desk?
No matter how thorough the software on-boarding is, adjustments will eventually need to be made to the software, and mistakes do happen. Your study should have personnel appointed to be an expert in the software design, and can save you time by solving problems in-house rather than waiting to hear back from the vendor themselves. Yet, in some cases, they will not have the knowledge of how to execute a certain modification, or may have forgotten how to perform an uncommon adjustment, so they should also be able to swiftly contact the vendor for expert advice.
Navigating the EDC maze
The cloud EDC space is flooded with vendors, some very simple, some very capable and some very complex. It can be confusing if you are new to EDC how to choose the appropriate software for your particular clinical trial. By using the aforementioned considerations, you will quickly find a suitable software vendor.
Also, make sure that you do not rush. Allocate time to follow each step thoroughly, and to completion before moving forward. The time you invest prior to implementation will save you time on your study.