02 BOOK OF ABSTRACTS .indd

Web-Based Electronic Data Collection: making clinical
trial data collection simple and reliable
Ivan Pavlovi} and Damijan Miklav~i~
University of Ljubljana, Faculty of Electrical Engineering, Tr`a{ka 25, 1000 Ljubljana,
Slovenia; contact: damijan@svarun.fe.uni-lj.si
Despite the fact that Electronic Data Collection (EDC) tools have been available for
more than two decades, clinical trials are still mainly conducted using paper data
collection as the primary tool. The answer for this can be partially contained in the
fact that standards for interchange of clinical data among different parties have to be
developed, and that these standards should be extended to facilitate data collection
at the investigation site. Present technological applications often do not have
adequate functionality to meet the current needs. In addition, available commercial
applications are usually economically acceptable and the cost is reasonable only
for the large-scale trials. And even then they can hardly meet special trial needs,
like integration of other data sources and medical devices. It is inherent to the trial
process that it can be modified during the study, and thus EDC system should be
flexible to support those changes. With respect to all demands listed above it is still
hardly possible to expect a single system that could suit the variety of different trials
needs.
At the Laboratory of Biocybernetics (Faculty of Electrical Engineering, University of
Ljubljana) we develop customized web-based EDC systems for clinical trials. We use
Internet technologies to reach mobility, to enable multimedia content and to achieve
wide user acceptance. This approach let us reduce clinical trial costs and duration
in following ways:
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• Study can be conducted on the existing computer infrastructure
– investigators need just a web-browser installed on any PC with access
to the Internet.
• There is no need for software installation or maintenance on the
investigator’s site – the system is set on our servers or on the servers at
any other institution which offers web-hosting.
• Multi-center clinical trials are supported by the system.
• Data monitoring time and expenses are reduced due to anytime access
to the data from any computer.
• Data cleaning time is reduced due to the integrated data validation
routines which do not let investigators to enter meaningless or erroneous data.
• Trial can be followed on daily basis through the online statistics.
• Further data analysis can be done by data export to appropriate form
(like Excel table or text file).