If you’re only familiar and comfortable with running paper-based trials, making the switch to electronic data capture (EDC) can sound quite intimidating. A few years ago we may have said, “EDC is the way of the future,” but now it’s the standard. The reality is that traditional paper-based data collection is an outdated method. Yet, some people are still resistant to adopt EDC even though innovation is enabling better solutions. Change can be hard, but successful researchers are flexible and keep an open mind to new possibilities. They know technology is only going to continue to evolve and make the decision to embrace it. Of those who have made the transition to EDC, it usually was not as difficult to learn as they originally thought. Read on to discover the benefits of EDC over paper.
Improves data quality
EDC software is a great tool to create and store electronic case report forms (eCRFs). Programming edit checks into eCRFs prior to data entry prevents unnecessary or irrelevant information from being captured and makes sure that only logical values are recorded. Consequently, if a value is entered that is outside a predefined range, or if a required field isn’t filled out on a particular form, the system automatically generates a query to be resolved. This results in fewer errors and helps enforce data quality and completeness.
Accelerates study completion
An EDC system allows studies to be completed quicker because it streamlines the work required to conduct a trial. Forms are created, data is entered, queries are resolved, and data is locked all in one system, in real-time. This reduces the waiting and/or travel time for monitors, data managers, and coordinators, and the sooner they complete their part, the closer a study can be to completion.
Makes it easier to find what you need
An EDC system allows authorized users with an Internet connection to remotely access clinical data from any geographical area. With one fully searchable central location, there’s no sifting through boxes for one form — no more digging through large volumes of paper or referring to multiple folders, binders and documents in various locations. You can spend less time worrying about where to keep your forms because patient data is safely stored and backed up in a cloud-hosted system. Since all forms are available in one place, it is also easy to reuse one across multiple protocols. Additionally, if you’re making a change to a form, it takes the guess work out of which is the newest version.
Is more secure
Data recorded on paper can be altered in a manner that’s nearly impossible to detect. An EDC system has audit trail functionality, in which every change is tracked. Since patient safety is a huge concern, data can only be accessed via role-based permissions in an EDC system. Electronic signatures require a unique username and password to log in and perform certain actions. An EDC system must have many technical controls in place to be compliant, including 21 CFR Part 11 guidelines put forth by the FDA. To complete the validation process, you have to start with a validation ready system.
(Related webinar: Examining 21 CFR Part 11 and the Role of Technology)
As drug and device innovations continue to develop, so do software solutions that help enhance and accelerate clinical research. EDC has become a reliable and preferred method of data capture that can greatly improve study management. The advantages of EDC over paper include cleaner data, quicker study completion, easier access to find what you need, and increased security. To this day, there are plenty of individuals who do not consider themselves exceptionally tech-savvy. Software vendors have taken this into consideration and purposefully develop user-friendly solutions. Learning a new system can certainly be an adjustment, and no matter how advanced technology becomes, quality and accuracy will continue to be of utmost importance. With the right EDC system and training, the transition will be easier than you think. Be sure to read this article about questions to ask when evaluating software.
Author’s note: This article was originally published on 2/7/14.