Understanding Electronic Data Capture (EDC)
Now, it’s not really just from paper to PDFs, but I needed something to catchy and I was hoping to utilize some alliteration to make this snazzier and me seem more like a wordsmith #Lyrical. But these past few weeks have been quite hectic for me as this will be my final full-time academic semester of my undergraduate career. As a result, I’m in my senior capstone class which is starting to take up a lot more time than I would like to dedicate as well as currently in my final science course, biochemistry. It doesn’t seem like a big deal, but it’s my last chance to try and boost up my science GPA (sGPA) prior to applying to medical schools this upcoming cycle. Fortunately, I’ve had the time to shadow and meet some brilliant CEOs and CMOs at my internship for a Health IT startup company and I was introduced to the concept of Electronic Data Capture (EDC). This startup is currently going through clinical trials which is how I first heard of this concept and term. Overall, it is simply an attempt in the industry to moev away from paper documentation, and by being able to initially capture the data electronically instead of having to migrate it and copy things over, it has potential benefits of increasing efficiency and decreasing unnecessary costs to name a few.
I agree that EDC is kind of a generic sounding term, but hey, Health IT isn’t exactly composed of the most lyrical and creative minds all the time. Modern EDC is typically a web-based and thin client, meaning that the software runs entirely on a web server and all it requires is a web browser connected to the internet. In a sense, you could imagine this as a cloud-based web application that allows you to input data. According to OpenClinica, there are three primary categories of EDC software users:
- Sites – Which are the locations or entity that coordiantes and collects the data. In a healthcare system, that is usually the hospital or clinic, and the study coordinators are tasked with entering that data into the EDC system. The investigator, which will normally be the head researcher or physician in charge, will then review and electronically sign the data.
- Sponsor – This is the organization that owns the trial, or the people that helped to push a clinical research study forward. Aside from the medical staff, employ various people like bioinformaticians, data analysts, data managers among many others to help plan for and analyze the data collected as well as to ensure the data is cleaned up and usable for the data analysts to work with. The sponsor will essentially ask the questions or queries that the sites try to resolve and collect data regarding.
- Contact/Academic Research Organization – They are in fact the big cheese and the intellectual backers of the sponsors. They work together with the sponsors to facilitate the planning and help to conduct the clinical trials.
When I spoke to the CMO/CTO about why the switch to EDC software despite it taking out a considerable chunk from their investment capital money that they had earned, he explained that it was going to be a slow ROI but it was meant to help provide cleaner data by having a software perform quality checks and more efficient processes because it can help guide the workflow of the research and study. Because it is using a web-based interface, the software vendors are inclined to make sure that there are plenty of security features that are meant to protect the data and ensure it can be backed up as needed. Additionally, it does have its regulatory requirements so EDC vendors also have to take their security and technical controls one notch higher to ensure data integrity, which is a leg of the CIA triangle (Confidentiality, Integrity, and Availability) in order to have a protected and well running data-driven system.
Additionally, instead of having all of the paper notes tucked into a manilla folder unorganized, their EDC software allows them to have real-time access to the data and even remotely view the data during a clinical trial as well. But the lead investigator whispered to me that it was really more for the “ctrl+f” function to search through all of the notes when they needed it instead of having to pour through stacks of paper notes. Especially when someone decides to search through the paper stacks and completely messes up the ordering, the investigator told me how it’d take twice as long trying to organize it back than it did for someone to just find what they needed.
I later emailed the investigator hoping to do some further research about EDC and why they made that switch, this was the response:
“Eliminates, or at least significantly lowers, data errors as a result of transcription. Reduces costs by eliminating the need for data transcription from paper to electronic systems. Gets the data to the people who need it faster, since you’re not waiting for anyone to transcribe it. If it’s a well integrated system, a lot of running around can be eliminated since Person A does an activity, which will then trigger Person B to know they have to do something else.”
Fortunately, being a burgeoning Health IT startup company, most of the employees and researchers are relatively familiar with using a computer systems, however there are downsides to switching to a “novel” technology. Simply put, it’s not super easy and as intuitive as simply writing down notes on a piece of paper. I’ve seen people struggle with trying to write out an email or formatting a Word document, so trying to have them use a new computer system instead of what they were doing for years before can prove to be a difficult task. Though people eventually get the hang of using the new software, it does have a learning curve without a doubt.