Understanding Various Site Use Cases for eSource and EDC
Efficient and compliant data capture can make or break the success of a clinical research trial. Utilizing a comprehensive, site-centric eSource or electronic data capture (EDC) platform can streamline a site’s data capture, management, and compliance.
Defining eSource and EDC
First, it may be helpful to define eSource and EDC.
Typically used for investigator-initiated trials (IITs), EDC is used for transcribing paper source into an application, with a team providing downstream analysis for endpoint adjudication and data submission. In IITs especially, EDC users are responsible for submitting their own data.
Conversely, eSource is used for collecting visit data. This is essentially a fit-for-purpose replacement of the electronic medical record (EMR) for collecting data during visits. eSource users will turn their data over to their sponsor via the sponsor’s EDC application.
Using eSource Instead of Paper
Designed to help sites accomplish necessary data capture activities and workflows, eSource enables research staff to capture all necessary information for both research and standard-of-care purposes. Site staff need a system to help them scale their studies, be efficient, and put the correct workflow structures in place. This helps multiple investigators meet with different participants on different days, while also feeling confident everyone is doing what’s necessary to keep the study moving.
An eSource platform enables easy coordination between staff members as well. With a high volume of information and data coming in, it can be easy for data to get lost in the mix, or for staff to give or receive old data. Keeping everything electronic helps minimize the risk of information getting lost in the shuffle of paper.
Additionally, eSource helps with analyzing data. For example, if there are questions about lab results, staff can work internally with the care team to identify any clinically significant findings. Using an eSource system can improve quality and compliance by ensuring only designated roles such as investigators can identify a result as clinically significant or not significant. Having this capability helps sites maintain efficiency and compliance throughout a study.
There is also oversight when it comes to remote monitoring in eSource. A big advantage of eSource is the ability for remote monitors to easily access and review data, and issue queries when there are questions. This enables both sites and sponsors to monitor data quality, accuracy, and reliability as the study is going on.
Using eSource Instead of an Electronic Medical Record (EMR)
Many sites have an EMR platform in place, but the EMR doesn’t meet their needs to capture and manage source data. This may be due to the burden created for site staff from leveraging an EMR to capture source data, or the EMR’s inability to capture the information in a compliant manner and export the data out of the system in a structured way.
In cases regarding compliance, even though organizations have a system to allow data capture, it doesn’t fulfill the needs and requirements for research trials. Sites need the ability to appropriately capture the clinical research data in a compliant manner, as well as the ability to access data back out of the system in a structured fashion.
Using EDC for an IIT
Primarily, a site-centric EDC platform serves organizations conducting IITs, trials where investigators act as the sponsor. In these trials, there’s no sponsor providing the EDC technology for the site to submit trial data, and instead the organization needs to manage data entry themselves.
While the investigators will perform the clinical research activities, they also need to submit results for Food and Drug Administration (FDA) acknowledgement, guidance, and approval. Using Advarra’s eSource + EDC platform provides the capability for organizations to do their own independent research without a separate industry sponsor related to the study.
Advarra eSource + EDC is a 21 CFR Part 11-compliant system, helping sites:
- Capture data appropriately
- Have the necessary audit trail
- Enable remote monitoring of the study
- Send accurate, valid documentation to the FDA
As sites and institutions are conducting IITs, typically, they are collecting data on paper. Research staff are going to participant visits with paper forms to collect data, to which they will later transcribe into the EDC platform. Digitizing this information enables staff to export the data, do downstream processing, and complete statistical analyses, while also managing study calendars, visits, and forms. Implementing the appropriate technology platform for data capture is critical to a clinical trial’s success. While different organizations will have different needs regarding the use of eSource and EDC capabilities, any research site can benefit from a purpose-built eSource + EDC platform.