Living without a data management system

Abstract

The implementation of a typical electronic data capture (EDC) system for clinical trials - encompassing data entry, validation and reporting tools - involves modeling electronic case report forms (eCRFs) for data that will be entered by investigative trial sites, providing web access for the sites to enter the data, managing a 'cleaning and locking' process (in which any queries against the data are resolved), and transmitting the final data to SAS datasets. Other clinical data not included in CRFs, such as laboratory data, are typically handled in a separate clinical data management system; this information is not directly linked back to the trial sites and therefore is inaccessible for review. Thus, activities such as seeking site feedback on out-of-range laboratory values can only be performed by manually transcribing queries from the data management system into the EDC system. As the number of studies using EDC systems escalates and the number of studies gathering data on paper diminishes, the inefficiencies of handling data across different systems are becoming increasingly apparent. This article explores the opportunities, risks and technical requirements needed for an integrated EDC environment to enable a discontinuation of the use of older data management systems.