NEW CAREER OPPORTUNITIES
The Role of CRAs in the
Development and Implementation
of Internet-based Clinical
Trial Applications
PEER REVIEWED
x 17
The goal of this paper is to
describe…what new career
opportunities are now available
to CRAs with the advent of
Internet-based clinical trials.
Internet-based clinical trials (IBCTs) are radically changing the clinical research
environment. Kelly and Oldham (1997) addressed the barriers to entry for imple-
menting IBCTs, as well as their obvious advantages and potential impact on drug
development. Kuchenbecker, et al. (2001) emphasized the emerging role Internet
technologies for data acquisition in clinical trials and reinforced the concept that
IBCTs can and should be effective in collecting clinical data. The article predicted
the eventual common use of IBCTs in the pharmaceutical industry. Richardson
(2003) provided specific details on how to plan and execute an IBCT.
When properly designed, IBCT solutions offer a convenient, cost-effective
approach for clinical sites to enter data, for CRAs to monitor a study, for data man-
agers to more effectively assure data quality, and for project managers to evaluate
the study status in “real time” (Mitchel, et al. 2000, 2003a, 2003b). While there are
some intrinsic differences between electronic case report forms (eCRFs) and paper
case report forms (CRFs), visually they should basically look the same. The main
difference is that the eCRF interacts with the user at the time of data entry. For
example, if a value is out of range, the system informs the user to either explain the
value or go back and enter the correct value. There is also no longer a need to ask
the question at each visit, “Was there an adverse event: yes/no?” Instead, there is
usually a single location to report adverse events where the question is asked only
once. If there is more than one adverse event, all the coordinator has to do
is click on the icon that says “Add Another.” There is no need to print pages that
will never be used. The use of radio but