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G. Lotz, E. Zrenner, R. Wilke; A Software Solution for Data and Process Management in Clinical Reading Centers. Invest. Ophthalmol. Vis. Sci. 2009;50(13):3316.
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In international multi-center clinical trials vast amounts of various source data are generated. To ensure constant, unbiased and high quality results, those raw data files are often evaluated in specialized reading centers. This implies complex management and coordination of data exchange, processes and responsibilities within the reading centers. Here we present a software solution which addresses these issues.
The implementation of the reading center software is based on a customized Enterprise Content Management (ECM) System. This system serves as a platform for all reading center related communication, data exchange and process management. To fulfill legal requirements regarding security and traceability, access is only possible via a secured connection; every person involved is assigned only certain rights to handle his specific tasks; all actions are logged in a consistent audit trail with versioning of data files. Standard Operating Procedures (SOPs) of the reading center are digitally implemented as monitored business process rules which can be adapted to special study requirements.
The software is currently realized as a pilot system for the Tübingen ERG Reading Center. It features the creation of a single, consistent audit trail for the entire reading center, which would be impossible with human coordination and data-exchange by e-mail or ftp. Since the SOPs are digitally implemented within the system, their compliance is guaranteed at every point during the study. Double reading of each raw data file is done by two independent readers and an approval by a senior reader only in case of major discrepancies. During all processes raw data and reading results are constantly validated against their data definitions as described in the SOPs. Such critical and time-consuming tasks can be performed automatically in the background without human interaction, including also pseudonymization of all data for reading. All this unburdens reading center personnel which can then concentrate on their core tasks.
Reading center software implementing data and process management has enormous advantages over the error-prone approach using conventional data exchange and human coordination. It can not only help to reduce the error rate, thus increasing the reading centers’ overall quality, but also it can improve legal compliance and user comfort.
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