Electronic Data Capture (EDC) systems are used for management of clinical trial data. The systems are accessible to clinical trial sites and Sponsor users through secure Internet connections and common web browsers. The process and infrastructure supplied should meet or exceed all regulations required by FDA, including 21 CFR Part 11. The 3 major components of an EDC system are a user interface for data entry, a series of simple and complex edit checks to provide cleaner data and suite of reports to manage trials on a daily basis.

EDC has come a long way since its beginnings in the late 1980’s. Back then; it was called Remote Data Entry (RDE). The RDE process involved deploying laptops at each clinical site which needed to be installed and supported. The software was loaded onto each laptop (thick-client) and data was retrieved on a regularly scheduled basis. There were some basic edit checks associated with RDE systems as well, however nowhere near as complex and powerful as those used in EDC.Benefits included cleaner data which could be retrieved more frequently than paper-based trials. Unfortunately, there were many disadvantages. Deploying and supporting laptops at every site was costly and an IT nightmare. The Internet was still new and connectivity speeds were at a fraction of what they are today. Sites became frustrated and confused having to manage a laptop for every study. As a result of increased Internet speeds, web-based software was introduced and RDE fell by the wayside.

With the addition of dynamic eCRFs, more sophisticated edit checks, a more user-friendly interface, high speed connectivity and a stable environment, EDC is now readily accepted in most clinical trial settings.