Clinical Internship with the Anterior Segment Clinical Division at Alcon Laboratories, Inc.: Electronic Data Capture (EDC) Apporach vs. Paper-Based Approach to Data Management

Danyel C. Crout B.S., University of North Texas Health Science Center at Fort Worth

Abstract

Although electronic data capture (EDC) has been available for 20 years or more, companies have remained hesitant about its applicability to enhance clinical trial conduct. Before any company adopts a process that is new to their organization, the procedures and regulations must be practiced and perfected. Pilot trials are developed to gain more knowledge and ease about the proposed process change. Already this year, the clinical data management (CDM) department reported that they have processed over a quarter-million paper case report forms (pCRFs). CDM is an integral component in maintaining clinical trial databases to be used during FDA submissions for approval to market a test article, therefore, data management processes are constantly improved while options are cyclically evaluated. EDC has been recently recognized within Alcon as a possible alternative to improving the efficiency of data collection while simultaneously decreasing data processing time. As a result, this prospective option was compared against the two processes of data management that Alcon currently uses with paper CRFs.