About Us » CTC Newsletter
- Welcome!
- CT Trial Improvement Campaign 2006
- Town Meeting
- Meet the CTC Team!
- Clinical Trial Compliance Questions & Answers
- Test Your Knowledge!
Clinical Trials Compliance Office
Welcome to the launching of the Clinical Trials Compliance website! As
many of you know by now, the national climate of regulatory and law enforcement
officials is currently focused on reducing fraud and abuse in research. Because
the College of Medicine conducts the majority of clinical trials in the
Health Science Center we have made a commitment to get out in front of this
significant concern. The Clinical Trials Compliance Office was created to ensure
that we comply with all federal and state regulations that govern our clinical
trials research. Of special concern is the complexity of these rules as we interact
with hospital services. There will be significant and necessary changes
made over this next year as new required policies, procedures and materials are
introduced. This website is one of several resources offered that will help us
accomplish our goal.
Clinical Trial Improvement Campaign 2006
In August, 2006 the Ad Hoc Committee for the Clinical Trial Improvement Campaign kicked off with a loud bang! We are 54 members strong. Folks have joined the Committee from the University of Florida Health Science Center research administration, investigators, coordinators, grants personnel as well as from Shands Hospital and Faculty Group Practice administration, financial and billing personnel. The goals of the Committee include: Contributing to the building of a centralized system of procedures that are efficient, effective and supportive of our policy and standards; contribute to the building of a centralized system of procedures that permits us to track, report, self-evaluate and continually improve upon; and develop a closeout process that concludes our clinical trials in a clear and well-documented manner that demonstrates compliance with all applicable laws and regulations that pertain to clinical trials.
A big "thank you" goes out to all the Committee members for providing their valuable time, energy, comments and suggestions and especially for the profound dialogue that allows us to explore the multi-layered issues that concern us all. There is a lot more to come from this group so stay tuned!
GREAT JOB!
back to top We called for a "Town Meeting" April 8-9, 2006Peter Pevonka & Yvonne Brinson
Did You Miss It?
The Town Meeting was a snapshot into the national climate of clinical trials
fiscal compliance and an introduction to identify areas we would like to give
attention to here at the University of Florida. [watch Video]
Meet The Clinical Trials Compliance Team!
M. Peter Pevonka, MS, RPh, FAPhA
Senior Associate Dean Research Administration and
Compliance & Associate Vice President for Research
The Senior Associate Dean for Research Administration
and Compliance provides oversight for
research administration of the College of Medicine
and coordinates the general research functions
for the College of Medicine (COM) Dean's
Office. The Sr. Assoc. Dean represents the COM on various institutional committees,
and interprets federal, state, and private granting agency policies and
procedures; and oversees COM matters pertaining to conflict of interest
(financial and other), compliance with IACUC and IRB guidelines, and scientific
integrity for the College.
Yvonne B. Brinson, RN, MHSc
Director
Yvonne launched the new office of Clinical Trials Compliance in December, 2005. As
the Director, she is charged with ensuring that the conduct of clinical trials complies with
the laws and regulations that pertain to clinical trial fiscal
activities. Yvonne began her nursing career in 1980, first as a critical care nurse and later as
an air ambulance flight nurse. She transitioned to clinical trial research in 1986, as a study
coordinator for industry-sponsored studies as well as NIH funded research. She served as the
Project Director for the UF Clinical Center for the Women's Health Initiative (WHI), which
was an NIH funded, $14M, 11-year study of postmenopausal women. Two clinical sites were
established, in Gainesville and Jacksonville, and over 4800 study participants were enrolled.
Her responsibilities included the overall management of operations, budget, facilities, and
personnel for over 36 team members. She received her Masters in Health Science from
NOVA Southeastern University in 2004. Yvonne's experience in clinical trials provides a
broad perspective of the entire research process within the Health Science Center.
Felicia Fitzgerald
Auditor
Felicia joined the Clinical Trials Compliance Office in September, 2006. She is responsible for developing tracking and monitoring procedures for clinical trial fiscal activities and conducting routine compliance reviews to ensure institutional compliance policy and standards are met. Felicia began working at the University of Florida in 1999 in the Department of Molecular Genetics and Microbiology. She then held positions as a Grant Specialist for the UF Shands Cancer Center Clinical Trials Office, and as a Senior Grants Specialist in the Office of Engineering Research, College of Engineering. She is experienced in creating clinical trials budgets, negotiating with sponsors, handling fiscal activities in People Soft as well as reviewing and paying invoices involving hospital services. She is also experienced in originating new IRB submissions, preparing continuing renewals and managing the closeout of research studies.
Verlisa H. Ward Assistant
Verlisa joined the Clinical Trials Compliance Office in April, 2006. She is responsible for managing all of the daily office functions and services. Verlisa served in the United States Army for 6 years as a Sergeant where she was in charge of issuing Army supplies. She has been with the University of Florida since 2000, working in the Office of Graduate Minority Programs, University of Florida Research and Graduate Programs. Her work included supporting the office in its mission to contribute to campus diversity and increase the number of underrepresented graduate students at the University of Florida.
CTC Question and Answer Corner
By Yvonne Brinson. You may send your questions or comments to the Office [verlisaw@dean.med.ufl.edu]
Q: What is the Office of Clinical
Trials Compliance?
A: In December, 2005, the Clinical
Trials Compliance Office was
created to develop, coordinate,
communicate, plan, implement,
monitor, and report fiscal compliance
policies, standards and processes
for clinical trials research.
We are charged with ensuring that
the University of Florida, College
of Medicine complies with all
federal and state regulations that
concern clinical trials. See more
about the responsibilities of the
Office.
Q: This is a really big job you
intend on taking on, how long are
your arms?
A: I hope they are long enough!
But you bring up a good point.
There are many areas for us to
focus on when we discuss compliance
issues in clinical trials,
therefore right now we are concentrating
to ensure that as an institution,
we are following all the
federal and state regulations regarding
billing for services to the
government and other 3rd party
payers. There is often a misconception
that this is a problem limited
only for those who bill such
as hospital billing personnel. Actually,
in order to make sure billing
is correct, the work has to begin
during the Pre-Award phase at
the University of Florida with our
Investigators while they are contemplating
starting a clinical trial.
Please visit the Starting Out Right
section of the website for more
information on how to comply to
these regulations.
Q: This website is complex and
contains a lot of information we are
responsible for knowing . How will
we be able to figure all this new information
out?
A: The website reflects how large
and complex the clinical trial process
really is. However, we have attempted
to present the information
systematically and offer as much
clarity as possible by breaking down
the process into Phases. The website
is a work in progress. It will evolve
as our clinical trials processes develop
and mature. The website was
also created to be a part of a much
bigger communication effort. It is to
be used in conjunction with the
classes and certification process that
will soon be offered as well as telephone
and on-site individual assistance
that our office is now offering.
Q: Are these new procedures being
developed really going to help us or
are they only adding more bureaucratic
paperwork and will slowdown
the process of conducting trials?
A: The new procedures will definitely
help us follow the rules and
avoid federal penalties. In terms of
operations, initially, I think both will
happen. Although the implementation
of any new procedure can slow
down the process at first, our goal is
to make the process smoother in the
long-run. The more complete our
study set-up or pre-award phase is,
the more efficient the study will be
to conduct. One of our goals is to
demonstrate that at UF we can comply
with all the federal and state
regulations in the most efficient and
cost effective manner.
Test Your Knowledge!
Listed below are additional
questions. See if you know
the answers.
Q: Will your office or the
Research Administration and
Compliance Office (RAC)
determine financial feasibility?
Q: Are there different procedures
to follow that depend
on what type of clinical trial
we plan to conduct?
Q. What is the National Coverage
Decision?
Q: What do we do if the trial
is not a qualifying trial according
to the Center for
Medicare and Medicaid Services
(CMS) policies?
Q: What happens if the
study loses money?
Q: Why do we need to submit
an internal detailed
budget, and what if our
budget is different than the
Sponsor's budget?
To find the answers to these questions and more, go to the FAQ Section.
