The Journal of mHealth Vol 3 Issue 5 (Oct/Nov) | Page 38

An Innovative Approach to Academic Medical Research IT
Continued from page 35

offer a better alternative to paper-based
forms, but they do have their downsides
too. There are issues concerning security and privacy (e.g. compliance with
21CFR11 and HIPAA), data ownership,
lack of flexibility and features, responsibility for lost data, and many more.
And as the study complexity increases,
the limited functionality and inflexibility of third-part web-based survey tools
become more evident.
Modern medical research studies tend
to have complex requirements that are
not accommodated by the methods
mentioned above. Research protocols
may involve multiple clinical sites,
study arms and participant types. The
data collected on the research study may
include complex data files and types like
EEGs, MRIs, medical records and pedigree charts that need to be reviewed and
have patient identifiable information
removed. The data collection forms may
have questions or workflows that are
not implementable in the survey tool.
This list is by no means exhaustive, but
I want to emphasise that paper forms
and 3rd party survey tools are probably more suited to simple data collection only, because they don’t address the
full range of requirements of modern
medical research projects. As the study’s
requirements and complexity increase,
the use of paper-based forms and third
party web-based survey tools become
unwieldy and inefficient very quickly.
It was for this reason CLIRINX was
developed. Our experience had shown
that there was a lack of options for
medical researchers when it came to
web-based study management and electronic data collection. Existing vendors’
software products were too complex
and expensive to purchase and maintain, and didn’t adequately address the
needs of medical researchers. Research
studies don’t have the budgets to pay
for expensive software, such as the upfront purchase price or on a usage basis
(e.g. SaaS). And vendors are in the business of selling software, not providing
the research study with the full array
of IT expertise that the research study
needs. Since 2004, we have provided
IT leadership on multiple