With summer upon us in a few eeks, you may be thinking, “What can I do over the busy
vacation season with my research compli-
ance program?” Every now and then, I have
someone call me and ask what areas are most
important for research compliance. As hot
button items go, there are many that
one can choose from to do a pro-
cess review or a gap analysis. But a
couple stand out if you want to get
into a summer state of mind for com-
pliance that doesn’t take a large team
in place to do!
Sites and principal investiga-
tors (PI) want their money from
trials. Many times, there is a lack of struc-
ture around residual balances. This can be
problematic if it is not tracked appropriately.
Federal funds not booked toward a grant
award must be returned. Sometimes you may
find the accounting out of sync with what
is actually left over at the end for a sponsored drug or device study. Problems can
arise when physician payouts with left-over
funds appear large without a policy in place.
Remember that when remaining funds are to
be moved to a discretionary fund, someone
might decide that not invoicing anything to
the study will create a higher pool of money
at the end.
Knowing what a study truly costs starts
with a coverage analysis at the pre-award
point in time. This simple method to ensure
you are covering your true cost is a must.
Even when pricing a grant application for
patient care costs, a coverage analysis can
be beneficial. Cost accounting for grants is
important, but for sponsored studies, so is
accounting and funds distribution to the various ancillary services that provide support
for the trial. Do not forget to apply sponsored
studies funding to salary and effort for your
research team members too, because this
sometimes is missed. This is another quick
review that can be done.
Another area that you can easily review is
the procedures that occur prior to informed
consent. This can be done in combination
with a small billing review during the screening for an inpatient study. Reviewing records
for patients who have research-related activities while they are inpatients is a great way to
find not only consent errors in your clinical
practice, but in your billing practice as well.
This review is quick to do for a small study
and can provide insight into both regulatory
and billing compliance.
Indulge in a summer state of mind in
Summer is a state of mind
by Kelly M. Willenberg, DBA, RN, CCRP, CHRC, CHC
Kelly M. Willenberg ( Kelly@kellywillenberg.com) is President and
CEO of Kelly Willenberg, LLC in Chesnee, SC.
REFLECTIONS IN RESEARCH
Knowing what a study
truly costs starts with a
coverage analysis at the
pre-award point in time.