Summary
This document is a guide that outlines the five hallmarks of an Agile Electronic Data Capture (EDC) system. It begins by defining Agile Design and its advantages over traditional EDC systems, emphasizing the need for flexibility and efficiency in study builds. The guide details the first hallmark, which is the ability to 'spec in the system,' allowing data managers to create specifications directly within the EDC, thus streamlining the review process. The second hallmark is the presence of a true standards library that supports the creation and management of standardized forms across studies. The third hallmark discusses the elimination of custom functions, which often complicate the EDC process, by integrating necessary capabilities as standard features. The document further elaborates on the importance of interactive design reviews and user acceptance testing (UAT) as the fourth hallmark, and the ease of making amendments as the fifth hallmark. Each hallmark is presented with supporting examples and case studies to illustrate its significance in enhancing the agility and efficiency of clinical study management.
