Ever wondered how the data that is generated during a clinical trial is captured? The system used by most pharmaceuticals and CROs these days is called as an Electronic Data Capture or EDC as we know it. So what basically is an EDC? It is a computerized system which is specifically designed to collect data during clinical trials in an electronic format. This system replaces the traditionally used paper based system.
So how does an Electronic Data Capture work in human trials? Well, we need to know of the basic three components on an EDC. The first being the Graphical User Interface. This Interface is mainly used for data entry. This is the screen that the end user sees on his/her computer. Next comes the Validation component to check the user data for any obvious errors, and finally comes the reporting tool for data analysis. Most companies these days are spending significant amount of cost and man power to manage clinical trial activities as database building, monitoring and management of data using a variety of EDC systems as Inform, Rave, Oracle Clinical Remote Data Capture, Veracity etc.
This makes us think, why use Electronic Data Capture in clinical trials at all? Well, this system has a number of advantages. The first and foremost being error minimization. We all know that a bulk of data needs to be submitted to federal agencies for drug approval. Additionally, this data needs to copied multiple times too. Now imagine the Paper Based Method of capturing this data and the number of errors which may occur during the process, infinite right? And to top this, these errors which are generated takes ages to be detected in the paper based system. All this could lead to a major delay in getting approval for marketing of the drug and to reach the much needy patient. EDC systems, through their user friendly and systematic approach tend to minimize these errors to a minimum, thus ensuring a faster mode of submission to the regulatory authorities. The data, when entered in the EDC can be checked prior to saving it, finally thus minimizing errors right away. The EDC also immediately prompts for existing errors which can be rectified immediately. The trial sponsor thus monitors the progress of the trial in a smooth way and can make sure that there were no deviations from the protocol during the conduct of the study. Other advantages of EDC include saving up a huge space and unnecessary use of paper work, thus one can say that EDC systems are environmental friendly too!!
Electronic Data Capture in Clinical Trials has opened up a number of employment opportunities for potential candidates as well. There are number of people required in specific fields to develop an EDC system as well as maintain it. For example, we need more software developers and vendors to come up with innovative ideas for making EDC systems more user friendly and accurate. Similarly, we need more professionals in the field of Clinical Data Management and Clinical Trial Management Systems to manage EDCs. All said and done, one can conclude that EDC in Clinical Trials is an integral part of modern clinical trials and one can really hope for a brighter future for EDC systems.