The Fundamentals of Electronic Data Capture

Electronic Data Capture (EDC is the medical abbreviation) is admittedly a fairly generic sounding term, but in the clinical trials field it actually means something fairly specific: using systems to collect clinical trial data in electronic form as opposed to paper form.

At OpenClinica, we are immersed in EDC all day, every day. However it’s important to recognize that many participants in the field of clinical trials are still just getting their feet wet with EDC. So, here’s a primer on the fundamentals of EDC.

What is an electronic data capture system?

Modern electronic data capture software is typically web-based and utilizes a thin client. Web-based means that the software runs entirely on a Web server (think Google.com), and thin client means that the only tool you need is an ordinary web browser (without any cumbersome plug-ins) connected to the internet in order to access and utilize the EDC software (again, think Google.com).

Clinical trial data may be captured electronically at its source (called e-source), or in paper form and later transcribed into the EDC system.

What is electronic data capture used for?

Today, the majority of clinical trials being initiated use electronic data capture software. There are three primary categories of EDC software users: sites, sponsors, and CROs:

• Sites – A site refers to the entity that coordinates and collects data from the clinical trial patients, or subjects; usually a hospital or clinic. Nurses or other designated study “coordinators” employed by the site will typically be tasked with entering data into the study’s EDC system. The site’s Investigator—the physician in charge of the patient’s care and patient’s data–is responsible for reviewing and electronically signing the data.

• Sponsor – The sponsor of a clinical trial is the organization that “owns” the trial. Biopharma, device, and other life sciences companies must sponsor clinical trials in order to get their medical innovations approved by regulatory authorities (like the FDA) before they can go to market with their product. Sponsors may employ a variety of people who use the EDC system in various roles. Monitors working on behalf of the sponsor may visit the client sites for source data verification, reviewing data source documents and verifying the accuracy of corresponding data in the EDC system (with EDC software this “visit” is often virtual). Biostatisticians help plan for and analyze data collected. Typically heavy users of EDC software, data managers have the responsibility is to ensure the trial data is clean and usable. Among other tasks, they may submit requests for information (called “queries”) to the sites to clarify and resolve data issues.

• CRO – A CRO, or contract research organization, is an entity that contracts with Sponsors to facilitate the planning and conduct of a clinical trial. In some trials, the CROs may effectively operate the trial on behalf of the sponsor. In other trials, they will take on only some of the key roles (data management, monitoring, analysis). In this regard, CROs may have many of the same types of EDC system users as sponsors. In academia, CROs are often called AROs (Academic Research Organizations), Clinical Trials Units, or Data Coordinating Centers. Their coordinating and management functions are much the same as their commercial counterparts.

In addition to the above types of EDC users, study patients may also contribute data to the EDC system, either directly through a specialized role in the software, or via a separate device and/or application that transmits data to the EDC system. The practice of patients entering data is called ePRO (electronic patient reported outcomes).

Why use electronic data capture software?

Today, the majority of new clinical trials use electronic data capture software. Some of the common motivations for using EDC include:

• Cleaner Data – EDC software is particularly good at enforcing certain aspects of data quality. Edit checks and source data verification programmed into the software can make sure data meets certain required formats, ranges, etc. before the data is accepted into the trial database.
• More Efficient Processes – EDC software can help guide the site through the series of study events, requesting only the data needed for the particular patient’s circumstance at a particular time. It faculties the process of clarifying data discrepancies with tools for identifying and resolving data issues with sites, and can help reduce the number of in-person site visits required during a trial.
• Faster Access to Data – Web-based EDC systems can provide near real-time access to data in a clinical trial. This insight enables faster decision making, and can support adaptive trial designs.

Each of the above reasons for using EDC addresses issues of efficiency and productivity, and can therefore also reduce the cost of clinical trials.

What is the difference between EDC and eCRF?

There is a difference between EDC and eCRF. Electronic data capture, EDC, is a software used for collecting clinical trial data. An electronic case report form, or eCRF, is a digital (usually web-based) questionnaire for collecting data about a study participant. eCRFs live inside the EDC, enabling clinical data managers and other clinical research stakeholders to collect better data, faster.

What is the difference between CDMS and CTMS?

CDMS and CTMS are different. CDMS, or a Clinical Data Management System, is a solution used by pharmaceutical and biotechnology companies for clinical data management during a clinical trial. An EDC, or Electronic Data Capture system, is similar to a CDMS because both are used to collect, store, and analyze participant data. A CTMS or Clinical Trial Management System is used for operational efficiency during a clinical trial. For example, storing clinical trial project management documents, tracking deadlines and milestones, and centralized billing processes.

Trends in EDC

In the 1990s electronic data capture was referred to “remote data capture” (RDC). Compared to today’s technologies, these systems were quite archaic, often built an a client-server architecture involving a thick that sometimes took the form of a specialized device, as opposed to an every-day PC. These systems were essentially data “silos” that had no easily ability to interchange their data with other systems.

Today, the integration of EDC software with other types of software in the eClinical spectrum (randomization, supply management, adverse event reporting, coding, submissions, etc.) systems is increasingly feasible and beneficial. The ability to quickly and reliably import electronic data from other sources (such as lab reports, imaging data sources, and electronic health records) is also becoming commonplace. The rise of open source EDC software and independent standards for characterizing and sharing data (like CDISC) are key enablers towards accelerating the productivity and decreasing the cost and burden associated with clinical trials.