Electronic Data Capture – The Basics

With all of the critical data that needs to be collected over the course of a clinical trial, one might assume that all of this data must be collected and managed electronically. Yet, this is not the case. While most clinical researchers have embraced the use of specialized software platforms to help stay on top of study data, there are still some who continue to collect, store, access and analyze data using old-school pen and paper or with software (like spreadsheets) that are not fit for purpose.

Electronic Data Capture – The Right Answer for Modern Clinical Trials

When a research team is ready to move beyond older data collection and management approaches, they turn to electronic data capture (EDC) systems. EDC, as can be ascertained from the name, involves collecting clinical research data electronically or digitally. Data can come directly from patients using decentralized clinical trial (DCT) methods that allow them to enter data via a laptop or smart device. Or, data can be collected at clinical trial sites by clinical team members and entered directly into the system on electronic case report forms (eCRFs). EDC also enables data to be collected passively via wearable medical devices or sensors. In a nutshell, leveraging an EDC platform helps researchers to collect more data, collect it faster and reduce human error, thus helping to produce more accurate and useful data. 

Working Smarter, Not Harder

The reason many researchers choose to continue using older data capture and management methods like pen and paper is the simple fact that they have been doing things that way for, likely, a long time and are comfortable. It can be eye-opening for many study teams just how simple an EDC can be to implement and how much easier the right platform can make their jobs. EDCs can dramatically reduce the amount of paperwork and other manual admin tasks commonly needed over the course of a clinical trial. Time and effort can also be saved when it is time to access data, as team members no longer need to thumb through paper files and decipher hand-written notes that may contain critical information. The best EDC platforms provide constant and often real-time access to data. With a few mouse clicks, study team members can get up-to-date insights on trial activities. This allows them to catch potential problems early and make fast decisions to keep the study moving in the right direction.

Safe and Secure

If you have ever misplaced an important document, you know that hard copies are not as secure as one might expect. You may think that folder is in the cabinet where it is supposed to be, but what if it isn’t? We have all had those panicky moments when a critical document is nowhere to be found. This gets at one key sticking point for some that have yet to move to EDC – an assumption that the data may not be secure.

Today’s leading EDC platforms utilize up-to-the minute encryption and security methods to ensure that data is stored safely in the cloud. Cloud encryption protects clinical trial data from server attacks and allows research teams to meet the strictest global security and regulatory compliance requirements, like GDPR. 

Easy to Start, Easy to Use, Easy to Access

Launching an EDC platform does not need to be overly complicated. In fact, some leading EDC solutions offer the ability for low or no-code study builds. Users can simply drag and drop which study features they need, making even mid-study protocol changes easy. This level of self-sufficiency allows study teams to keep things moving. No down time is required to wait for a third-party to come help reconfigure the system. 

The ability to take control without the need for deep coding expertise also makes it simple for researchers to engage with data in the system. Assets can be seamlessly replicated and repurposed from one study to another, saving time.

Finally, data access is simple with a well-designed EDC platform. It is your data after all. The right people can get to the data they need at any time. Role-based permissions are easily implemented, with roles assigned to each team member. Each person then gets access to the data they need to do their jobs, and only the data they need.

What Is Possible with EDC Software?

In short, EDCs allow researchers to work much more efficiently than older methods like pen and paper. Data can be collected faster, more accurately and more securely. Study teams get more consistent access to data. Some solutions even allow researchers to engage with study data via secure mobile applications, allowing them to stay on top of data whether they are in the office or traveling. As clinical trials continue to grow in complexity and data is collected via an increasingly diverse range of methods, choosing the right EDC platform can save researchers time and money while allowing them to more easily adapt to study changes.

For more information about Electronic Data Capture and how the team at Crucial Data Solutions can help you get started or improve your existing processes, visit www.crucialdatasolutions.com

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