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Large-scale Electronic Data Capture – When Size Is Not the Only Issue
Figure 2: Sample of Problems Encountered by Users Figure 3: Study Portal
(From Helpdesk Log)
User account 45%
Software 5%
OC RDC 16%
Hardware 4%
General 10%
Connectivity 20%
equipment. As part of the provisioning, Quintiles provided a available to users, who could also access performance metrics and a
multilingual helpdesk, available 24 hours a day and seven days a week, study contact database that included all the people connected with
to support EDC software and connectivity. The volume and type of calls the EDC solution.
received provided valuable feedback for Quintiles on the range of issues
that users encountered (see Figure 2). On a more functional level, the study web portal allowed users to review
patient listings prior to the patients’ arrival at a hospital or medical centre.
To resolve the software, connectivity and user account issues identified Thus, staff were able to anticipate and prepare in advance of a visit. Last
in this trial, Quintiles also set up a study web portal designed to but not least, the study web portal gave easy access to patient profiles
complement the helpdesk and allow the end-user to submit account for use in medical review (see Figure 3).
Summary
The benefits of deploying a fully integrated paper and EDC solution as
The traditional paper-based process described above are clear-cut. The traditional paper-based process and
and electronic data collection via
electronic data collection via Internet can all be implemented within a
single database where all information can be viewed in parallel by
Internet can all be implemented within
multiple team members. Furthermore, a central point of access to all
a single database where all information
patient listings and study documents is available via the web study
portal. The hybrid system obviates the risk of paper loss – all images are
can be viewed in parallel by multiple
available online – improves the cleaning process and provides easy
team members.
access for data review.
We have reached a tipping point in the deployment of EDC. More than
one-third of trials now use EDC, and the next two to three years will see
requests and password resets via email. The study web portal also rapid expansion across the rest of the sector. It is vital that CROs
served as a second point of access to information on the clinical trials. understand the issues and take the needs of the sponsors into account in
General study documents – such as protocol and eCRFs – were made order to ease the migration from paper to eClinical. ■
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