With little to no programming required, and reusability from global libraries and standardized forms such as CDISC's CDASH, deploying EDC can now rival the paper processes in terms of study start-up time.
EDC is often cited as having its origins in remote data entry (RDE) software, which surfaced in the life sciences market in the late 1980s and early 1990s.
Historically, this information was collected on paper forms which were then sent to the research sponsor (e.g., a pharmaceutical company) for data entry into a database and subsequent statistical analysis environment.
[1][7][8] However, this process had a number of shortcomings:[5][8] To address these and other concerns, RDE systems were invented so that physicians, nurses, and study coordinators could enter the data directly at the medical setting.
The most significant shortcoming was that hardware (e.g., a laptop computer) needed to be deployed, installed, and supported at every investigational (medical) site.
With the rise of the internet in the mid-1990s, the obvious solution to some of these issues was the adoption of web-based software that could be accessed using existing computers at the investigational sites.
In 2013, the U.S. Food and Drug Administration (FDA) introduced its eSource guidance, which suggests methods of capturing clinical trial data electronically from the very beginning and moving it to the cloud, as opposed to EDC's more traditional method of capturing data initially on paper and transcribing it into the EDC system.