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Title: CTSI newsletter
Physical Description: Serial
Language: English
Creator: Clinical and Translational Science Institute, University of Florida
Publisher: Clinical and Translational Science Institute
Place of Publication: Gainesville, Fla.
Publication Date: September 2009
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Bibliographic ID: UF00090016
Volume ID: VID00011
Source Institution: University of Florida
Holding Location: University of Florida
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From the Director

Regulatory Knowl-
edge and Research
Support Program

A New RFA

Meet the RKRS Team


Volume 2, Issue 5 September 2009

Volume 2, Issue 5 September 2009


INSIDE THIS ISSUE I


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.273.8700


here have been plenty of good things happening at the CTSI over the summer,
including the receipt of the CTSA; the integration of our CTSI members with
the NCRR's national CTSA Consortium; UF's position as a founding member
of the Society of Clinical and Translational Science; the constitution of both the Exter-
nal Advisory and Translational Science Advisory Committees; the scheduling of our
inaugural Research Symposium and Retreat for Feb. 11-12, 2010 (save the dates!); the
birth of the Institute's Research Portal (part of the RKRS Program); the issuance of our
first TL1 and KL2 mentored awards to an outstanding cohort of inter-college trainees;
the imminent publication of the latest Pilot Projects RFA; and the appointment of a new
Assistant Director of Administration and Operations for the CTSI, Ms. Marian Boyle.

Several members of the CTSI's leadership have also made recent important contribu-
tions to CTS:

Chris Batich, one of the Institute's Associate Directors and its Chief Operating Officer,
is co-inventor of Biogard, a microbacteriacidal polymer chemically bonded to a ban-
dage that traps bacteria and prevents their entry into wounds.

Mike Conlon, our other Associate Director who also heads the CTSI's Biomedical
Informatics Program, received very favorable news about a $12M application to assist
researchers nationwide network in conducting collaborative CTS.

Mark Brantly, co-director of the Shands Clinical Research Unit (aka GCRC) reported
in PNAS preliminary results of a study that could lead to future gene therapy trials in
patients with alpha-i antitrypsin deficiency, a rare, hereditary condition that can lead to
fatal lung and liver diseases.

Des Schatz, the Shands CRU other co-director, is principal investigator on a very
favorably reviewed NIH competitive renewal application to continue UF's participation
in TrialNet, a national consortium of institutions conducting research into the causes,
treatment and prevention of type 1 diabetes mellitus.

Sara Jo Nixon, the CTSI's director of its Biobehavioral Core, was elected president of
the international Research Society on Alcoholism.

Rus Bauer, co-director of the Institute's Tracking and Evaluation Program, was elected
president of the international Neuropsychological Society.

Continued on page 2















Volume 2, Issue 5 September 2009





We're anxious to learn about your success stories, so pass them along! Want to know how your research can be facilitated
by the CTSI? Read on about how the Regulatory Knowledge and Research Support Program can help.





Peter W. Stacpoole, PhD, MD
Associate Dean for Clinical Research and Training
Director, Clinical and Translational Science Institute


REGULATORY1lU~~[I'AI RIW Il KN WLDG AND RESARC S( U PP R PR G A BYl CURTIS ~ ~S~


Getting Things Done -- The RKRS Program
Brings Research to Life

At many research institutions coming up with good
ideas for research projects isn't the toughest piece
of the puzzle. The hard part is taking good ideas
and putting them into practice transforming concepts into
studies and slide-show bullet points into bricks and mortar.
The Regulatory Knowledge and Research Support Group
(RKRS) of the CTSI is charged with making the transfor-
mation as easy and efficient as possible for all the scientists
and researchers working within the Institute.

The RKRS encompasses four areas critical to successful
research. The first is regulatory assistance, helping re-
searchers navigate requirements of the FDA and other gov-
ernment regulators. Second is assistance with the process
of gaining Institutional Review Board approval, bringing
specific expertise and institutional memory to the process
of working with the IRB. Next comes research coordina-
tion, helping marshal the resources of various units and
researchers who can contribute to project success. Finally,
there is the biostatistics group to help bring meaning to re-
sults and assist in designing and reviewing projects to make
sure their design is optimal for proper analysis.


The grant application for the CTSI outlined four goals for
the RKRS. They are:

Increase accessibility of information about clinical and
translational research and training opportunities, by de-
veloping a physical and virtual (Web-based) research portal
in the Institute's academic home that will be managed by
the RKRS.

Provide expert assistance in the development of re-
search protocols by linking investigators to Research
Project Managers (RPMs).

Hold the applicant accountable to the highest standards
of scientific and ethical integrity by conducting research
protocol reviews in a rigorous, efficient and timely man-
ner.

Ensure rapid activation of outstanding research proto-
cols by providing prompt access to the required re-
search and/or training resources.

Reaching those goals will require the four major compo-
nents of the RKRS to work closely together while continu-
ing to serve the CTSI research community. I had a chance
to sit down this summer with representatives from the


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.273.8700













Volume 2, Issue 5 September 2009

Volume 2, Issue 5 September 2009

REUATR KNWEG AN RESARC SUPR PRGA


groups that make up the RKRS. Let's look at how they
plan to do things.

The Big Picture

The purpose of the CTSI as a whole is to facilitate research
from beginning to end, first research protocol to final clini-
cal trial, and out into the healthcare practice community.
The RKRS group is one of the key "pillars" that will sup-
port principle investigators and give them the knowledge
they need to support clinical and translational research.

The RKRS will provide a uniform "face" of clinical re-
search, helping the PI understand what needs to be done to
enable research to begin and proceed, what research-sup-
port resources are available at UF, and how they can be
used. Many PIs, whether new to UF or with years of expe-
rience, may not know about all the resources available. For
example, if they want to do research on a particular disease,
they can be guided to one of the many clinical research
units (CRUs) at UF that offer both inpatient and outpatient
facilities.

This group will make the information available to the PI in
a "one-stop shop" format, providing information and guid-
ance on issues about which researchers should be aware.
Examples of issues RKRS staff can help with include


conflict of interest questions, IRB approval, and FDA regu-
lations complex areas to negotiate without the kind of
expertise and institutional memory found within the RKRS.

The Individual Functions

The first function many researchers will tap into when
coming to the RKRS is regulatory, especially concerning
help dealing with FDA regulations. What kind of questions
can the RKRS help with? A young investigator, or even a
more experienced PI, may wonder about the necessity of
an Investigational New Drug (IND) application. How they
go about getting one and even whether one is required are
often challenging areas, and this group will guide them
through the process. How important is this? Unless the
researcher is well versed in the regulations contained within
the FDA's guidelines, then the contributions of the RKRS
staff can be vital.

Another area researchers need assistance with is the IRB.
All protocols involving human subjects must be approved
by the IRB, and the RKRS staff can assist investigators
campuswide navigate through the process and help them
understand the IRB requirements. Each protocol is unique,
and RKRS staff can help PIs decide on the type of submis-
sion required based on the goals of the research.
Continued on page 4


A New RFA
This month's newsletter announces the reissuance of the popular CTSI's RFA that was inaugurated one year
ago. In the past, RFA details have been contained within this newsletter, but we have now incorporated all of the
pertinent information within our CTSI portal at https://www.ctsi.ufl.edu/?q=current funding. Simply point your
browser to this site to read about the RFA and to download the forms for getting started. Questions? We have the
answers; just contact Denise Caswell at dcaswell@ufl.edu.

The application submission due date is October 30, 2009 by 5 pm and the project period award date is anticipated
to be November 16, 2009.

Good luck!


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.273.8700













Volume 2, Issue 5 September 2009

Volume 2, Issue 5 September 2009

REUATR KNWEG AN RESEARCH SUPR PRGA


Depending on the type of submission, approval for a
protocol typically takes three to six weeks. Assistance is
available to improve the quality of the submissions. The
goal is to make the process of approval less frustrating for
researchers and reviewers alike through education, assis-
tance, and quality improvement. As a result, approval time
also could be decreased. The proper balance of expediency,
efficiency, and human subject protection is where success
lies.

The research support function is perhaps the area to see
the most change as it fits within the CTSI. One of the most
visible changes will be the creation of a Web portal through
which each project initiated when the PI begins working
with the CTSI. As features are developed over the next few
months, PIs will be able to go to the site (https://www.ctsi.
ufl.edu/) and get information on the requirements to initi-
ate their research. In addition, RKRS staff will work with
researchers on the various things needed for their studies to
move forward. The RKRS staff will be able to say, "These
are the resources that are available, we can help you with
these issues," and then work with the researchers to obtain
the necessary help.

That's the crux of the coordination component, to simplify
and help navigate through the maze of forms and commit-


tees successfully. It's a huge challenge even for the most
experienced researcher to know what's available, and then
to figure out the best resources for a study. Keeping track of
which units are available for clinical trials, for example, can
involve a mind-numbing array of variables and scheduling,
and the RKRS staff will be able to look at which unit has
which resources and direct investigators so that research
doesn't hit any unnecessary delays.

The unit is RK and RS, so there are both regulatory knowl-
edge and research support functions. The two areas are in-
terconnected in how they ultimately work for the researcher
as it is important to have both parts working together.

The staff acknowledges that complete integration of the
support functions into a single, smoothly functioning unit
is a long-term goal. RKRS members estimate that if they
can achieve integration within five years it will be a great
success. Looking at the records of organizations receiving
CTSI grants three years ago, the group feels it has a head
start having had the opportunity to learn from the mistakes
and successes of those previous grant recipients. However,
members note that even the first CTSI recipients are no-
where near final status on bringing the various clinical units
under a single umbrella.
Continued on page 5


Employment
Did you know that there are multiple venues through which both internal and external jobs are posted?

For Job Seekers
https://jobs.ufl.edu University of Florida jobs postings.
http://www.union.ufl.edu/jobs/ Reitz Union student job listings.
http://www.sfa.ufl.edu/programs/workstudy Federal Work-Study Program.
http://www.sfa.ufl.edu/programs/ops.html Other Personnel Services jobs.
http://www.sfa.ufl.edu/programs/oce.html Off-Campus jobs.
http://www.sfa.ufl.edu/programs/vaworkstudy.html Veteran's Affairs Work-Study.


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.273.8700













Volume 2, Issue 5 September 2009

Volume 2, Issue 5 September 2009

REUATR KNWEG AN RESEARCH SUPR PRGA


The RKRS staff notes there are a lot of challenges in bring-
ing the clinical research units under a single umbrella,
because some functions within the units are overlapping
and it's important to define which unit will handle which
functions. These are critical distinctions to make, not just at
this level, but at a much higher level as well. Each process
or step will be informed by previous steps and iterations, so
the RKRS can achieve the goals established for it.

The fourth major area of the RKRS is biostatistics. Under
the CTSI grant, there is a research design and analysis pro-
gram led by Keith Muller, PhD, and Jonathan Shuster, PhD,
which is separate from the biomedical informatics core.
Biostatistics has become an important part of the overall
research process because a project may be correctly written
and ethical as defined by the IRB, but if the proper statisti-
cal analysis of the data can't be performed then the research
won't be able to answer the questions that were posed.

The biostatistics group will look at studies as they're being
formulated. Questions about whether the studies are prop-
erly powered, if they have the proper number of subjects
proposed for enrollment, and whether the study can be ex-
ecuted properly in order to get a good answer to the ques-
tion. If the answers to any of those questions is no, then
group members may help researchers redesign the study.
This puts the biostatistics staff members more in the role
of collaborator than simple resource. (repeated from graph
above) The goal is to help researchers get to the point of
answering the questions they have, do good science and get
the results published. This furthers the researcher's career,
UF, and science all goals the biostatistics division wants
to help accomplish.

If the study is well designed and clearly laid out on the
front end then it clearly makes things much easier for the
statistician working with the data on the back end of the
study. As the biostatistics staff is fond of saying: "GIGO
- Garbage in, Garbage out."


Why Now?

When asked why the CTSI and the RKRS component are
so important for today's research, the staff has ready an-
swers. Not just at UF but at almost all CTSI institutions, the
problem has been that no one has made common resources
available for clinical investigations. This is what the CTSI
is going to offer -- a common resource for investigations.

Typically, when a researcher begins a project, they must
hire a project manager, and laboratory staff, and they'll try
to hire a biostatistics person who understands what is being
done and can help write a protocol. They are, in essence,
building a research silo. The CTSI's goal is to break down
silos, creating communities and commonalities in research
that are impossible in the silo architecture.

This architecture is part of the academic culture of 'publish
or perish,' according to the staff. Investigators needed to
concentrate on their own areas of expertise, to publish in
their own specialties, and this traditionally runs counter to
the needs of interdisciplinary collaboration. In fact, in the
past, interdisciplinary collaboration was a distraction from
researchers' ability to move their careers forward. Institu-
tions everywhere did not reward the interdisciplinary work,
they didn't even recognize it. The RKRS looks then to
mark a paradigm shift, not just in the working of science,
but also in the institutional cultures ministering to science
by acting as agents and champions of change as well as
shepherds ofinvestigational support.


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.273.8700












II New slette


Volume 2, Issue 5 September 2009





David Nelson, MD, is Professor of Medicine at the University of Florida where he serves as
the Director of Hepatology and Liver Transplantation, and Director of the RKRS program.
He received his medical degree from the State University of New York Upstate University in
Syracuse, completed a residency in internal medicine at the University of Massachusetts, and
obtained fellowship training in gastroenterology and hepatology at the University of Florida.
Nelson's area of clinical expertise is hepatology with an emphasis on the management of viral
hepatitis and liver cancer. He also has strong basic research interests, focusing primarily on
the immunopathogenesis and treatment of chronic hepatitis C and hepatocellular carcinoma.
4F He currently oversees more than 15 active clinical trials and has a 10-year track record of
NIH funding. He serves as the principal investigator on both basic science R01 and a T32
training grant in gastroenterology. Nelson has an impressive record of academic achievement
with more than $8 million in research funding, more than 100 publications, and is currently associate editor for the















Robert Kolb RN, BS, CCRC has more than 20 years experience in clinical trials working on NIH-funded, industry-
sponsored and VA cooperative studies. He has conducted, managed or consulted on hundreds of protocols in all phases,
from international multicenter trials to investigator-initiated studies. A Registered Nurse since 1977, he is a long-stand-ogy.









ing member of the Association of Clinical Research Professionals (ACRP) and has held a certification as a Clinical
Research Coordinator (CCRC) for 17 years. He is a member of the Society of Research Subject Advocates (SRSA),
Public Responsibility in Medicine and Research (PRIMER), American Society for Bioethics and Humanities (ASBH)
and the Society for Clinical and Translational Science (SCTS).
Teresa d'Angeht, the RN, BSN, CCRC is the Director of Research Project Management. She has worked as a Research
are H. RCoordinator, both at the NIH and for industry-sponsored clinical trials. Teresa also is the nurse manager of the Shands
DougClinical Research Unit (formerly General Clinical Research Center). Teresa brings more than 30 years of research



experience Kolb RN, BS, CCRC has more than 20 years experience in clinical trials working on NIH-funded, industry-position.
Contsponsored and VA cooperative studies. He has conducted, managed or consulted on hundreds of protocols Continued on page 8
from international multicenter trials to investigator-initiated studies. A Registered Nurse since 1977, he is a long-stand-
ing member of the Association of Clinical Research Professionals (ACRP) and has held a certification as a Clinical
Research Coordinator (CCRC) for 17 years. He is a member of the Society of Research Subject Advocates (SRSA),
Public Responsibility in Medicine and Research (PRIMER), American Society for Bioethics and Humanities (ASBH)
and the Society for Clinical and Translational Science (SCTS).

Teresa d'Angelo, RN, BSN, CCRC is the Director of Research Project Management. She has worked as a Research
Coordinator, both at the NIH and for industry-sponsored clinical trials. Teresa also is the nurse manager of the Shands
Clinical Research Unit (formerly General Clinical Research Center). Teresa brings more than 30 years of research
experience to this position.
Continued on page 8


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.265.273.8700












II New slette


Volume 2, Issue 5 September 2009





Douglas Theriaque, MS received his degree in statistics from Southern Connecticut State University in 1996. Since
1997 he has served as the Director of Informatics for the GCRC, collaborating with more than 150 investigators and
co-authoring 57 peer-reviewed journal articles. During this time he also developed adverse event and subject schedul-
ing software systems as well as more than 50 Web-based electronic data capture (EDC) systems. Theriaque guided the
GCRC Informatics Core through two successful competitive renewals, with his core achieving "outstanding" ratings
from the NIH review committee each time.

In 2009, Theriaque accepted a position as project manager within the Regulatory Knowledge and Research Support
core of the CTSI. In this role he works with investigators in research project development and also develops and sup-
ports the CTSI Web portal.

Renee Collins, BS is a Research Program Manager with extensive knowledge of the Institutional Review Board and
regulatory issues. She was hired by the IRB in January to assist investigators with submissions. She has more than 15
years of experience as a study coordinator at Vanderbilt University, the University of Arizona, and SUNY at Buffalo.
She was also the Administrative Director of Regulatory Services for the departments of Psychiatry and Neurology at
the University of Arizona.

Wajeeh Bajwa, Ph.D. received his PhD in Biochemistry from the University of Glasgow, Scotland, in 1981 and did
post-doctoral work on yeast expression systems with Albert Hinnen, first at the Freidrich Meschier Institute (Basel,
Switzerland) and then at Ciba-Geigy Biotechnology Center (Basel, Switzerland). He joined Hershey Medical Center,
Penn State University in 1985. He then moved to a biotechnology company, Strohtech Inc, in Detroit. Bajwa relo-
cated to Durham, North Carolina with this company in 1993, company name also changed to Apex Bioscience, Inc at
that time. His group was the first to successfully express functional human hemoglobin in yeast. Bajwa then moved
to Duke University Medical Center, North Carolina, in 1998. Based on his work at Duke, the NCRR mandated the
Research Subject Advocate program for all GCRCs in 2000.

Bajwa's work spans a breadth from molecular and genetics work, to animal studies and to human clinical trials. He
specializes in GxP regulations and in dealing with the Food and Drug Administration.

Bajwa is currently Director of Regulatory Affairs and Licensing, CTSI, University of Florida.



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