Facilities and Resources
The collective resources at Wake Forest and the Wake Forest affiliates greatly contribute to accomplishing the
TSI’s aims of building on current high-quality programs, improving efficiency to accelerate the pace of research
translation by fostering team-based multi-disciplinary approaches, building innovative training and workforce
development programs for clinical and translational investigators, leveraging WF strengths, and catalyzing a
local and regional environment of accelerated discovery and implementation. All of these strengths will foster
the overall goals of the Translational Science Institute (TSI) and accelerate our evolution to a learning health
care system.
A. Wake Forest University and Wake Forest Baptist Health
History: Wake Forest University is a private, non-sectarian university founded in 1834. In addition to the
School of Medicine and the Undergraduate and Graduate Schools of Arts and Sciences, it is home to graduate
and undergraduate Schools of Business, the Divinity School, and the Law School. Wake Forest Baptist
Medical Center (WFBMC, the primary hospital and clinical facilities), the Wake Forest School of Medicine
(WFSM, the academic entity) and outlying affiliated hospitals and physician practices form Wake Forest Baptist
Health (WFBH), which is governed by a single CEO, Dr. John McConnell. This structure is shown below in
Figure 1. WFBH has over 1,200 faculty members and over 500 adjunct faculty members. WF has over 480
medical students, 64 Physician Assistant students, and 755 graduate students. WFSM is currently the fourthmost selective medical school in the U.S., with an acceptance rate of 3.1 percent.
Governance: The control of WFBH is vested in the Board of Directors, some of whom are members of the
WFU Board of Trustees. The Dean of WFSM, Dr. Edward Abraham, is responsible for the operation of the
School of Medicine through the President of the University (Dr. Nathan O. Hatch). The faculty, through the
Faculty Executive Council, has general authority over long-range planning and all major changes in policy that
affect the activities and welfare of the School (e.g. determining requirements for faculty promotion, student
conduct, and the MD degree). The Board of Directors is responsible for the overall supervision of WFBH. In
November 2008, John McConnell, MD, was named the first CEO of Wake Forest Baptist Medical Center.
Karen Barbara (Bobbi) Carbone, MD, MBA, is President and Chief Operating Officer of WFBH.
Current extramural research funding: Total funding in FY13 was $193.8 million, while funding in FY14 was
$193.4 million. NIH funding was $102.8 million, and Department of Defense funding was $30.5 million. Of note,
there was also an increase in funding for clinical trials in FY14, $69.1 million, from $64.7 million in FY13. The
Division of Public Health Sciences received $46.4 million among its 5 constituent departments. Other top
departments were Internal Medicine ($33.2 million), the Institute for Regenerative Medicine ($32.6 million),
Physiology/Pharmacology ($12.7 million), Surgery ($9.0 million), Pediatrics ($8.0 million), Biochemistry ($5.1
million), and Pathology/Comparative Medicine ($3.3 million).
Clinical overview: The WFBH catchment area is a 24-county region including western North Carolina and
southwestern Virginia, and extending to Tennessee and West Virginia. WFBH has 885 licensed beds; a level 1
trauma center; and active services in cardiac, renal, and hematopoietic stem cell transplantation. In FY14, the
Emergency Department had 104,678 visits; overall, the hospital had a total of 38,555 inpatient admissions, and
805,593 other outpatient clinic visits. The hospital is the largest tertiary care center for the Piedmont region of
the Southeast. US News and World Report ranks WFBH among the top 50 hospitals nationally in nephrology
(14th), urology (37th), cancer (42nd), and gynecology (49th). US News also listed WFBH among the top 25%
of all hospitals in eight categories: cardiology and heart surgery, diabetes and endocrinology, ear, nose and
throat (otolaryngology), gastroenterology, geriatrics, neurology and neurosurgery, orthopaedics, and
pulmonology. Importantly, WFBH was the first hospital in the Carolinas to receive Magnet Recognition for
Excellence in Nursing Service. We are currently 1 of only 23 hospitals in NC with this designation.
In 2014, Becker’s Hospital Review named WFBH as one of the “100 Great Hospitals in America”. This list
represents, in Becker’s view, “some of the most prominent, forward-thinking and focused health care facilities
in nation”. Specifically cited were WFBH’s quality and safety measures.
A.1. Brenner Children’s Hospital
Brenner Children’s Hospital, which opened in 1986, is a 160-bed, 400,000 sq. ft. “hospital within a hospital” at
WFBH that serves neonates through teens. In 2014, Brenner was recognized by US News and World Report
as one of the top nation’s children’s hospitals, ranked nationally in neonatology (26th) and Orthopaedics (39th).
The facility is the only children’s hospital in western North Carolina, and also treats children from Virginia,
South Carolina, and Tennessee. Over 4,500 children are admitted to Brenner each year, and over 21,000
pediatric subspecialty visits occur annually at the hospital-based outpatient clinics. Brenner Children’s Hospital
includes 120 pediatricians specializing in more than 30 areas of pediatric medicine, and the region’s only level
IV Neonatal Intensive Care Unit. Physicians also conduct 17 satellite clinics in twelve counties across western
North Carolina and southern Virginia. Over 5,500 children receive inpatient care each year, and there are more
than 28,000 outpatient visits annually.
A separate Pediatric Emergency Department, the first in western North Carolina, opened in 2011 and
increased the number of treatment rooms from 17 to 24. The Pediatric ED (24,000 sq. ft.) includes capabilities
for pediatric resuscitation, diagnostic radiography and computerized tomography (CT) services. Thus, the
WFBH Pediatric ED offers improved access to child-focused emergency and urgent-care services, increased
security for pediatric patients by separating them from the adult and general population, direct access to
Brenner Children’s Hospital and its Level IV Neonatal Intensive Care Unit, and coordination with the Childress
Institute for Pediatric Trauma (see below) to take advantage of the latest research and treatment protocols.
A.2. Childress Institute for Pediatric Trauma
Established in 2008, the Childress Institute for Pediatric Trauma (Executive Director, Robert Gfeller; Founding
Director, J. Wayne Meredith, MD) has set the goal of becoming a national hub for comprehensive research and
training for childhood injuries in the United States. The Institute includes pediatricians, surgeons, and trauma
experts. The Institute’s goals are to advance and widely disseminate the latest research and knowledge on the
treatment and care of children with traumatic injuries. It is developing training programs for educating all
members of the pediatric trauma multi-disciplinary team. The Childress Institute is striving to make a significant
difference in the survival rate of critically injured children nationwide. It will also take the lead in improving the
quality of life for those who do not fully recover. The Institute is focused on five key areas: fostering
comprehensive research projects in pediatric trauma; being a voice for advocacy and public policy; serving as
a credible clearing house for prevention education to providers; offering medical professional education,
including distance learning options; and comprehensive rehabilitation services.
A.3. Wake Forest Innovations
Established in 2012, the goal of WF Innovations is to translate academic and clinical discoveries into products
and services that will benefit patients. WF Innovations is led by Chief Innovation Officer Eric Tomlinson, DSc,
PhD. WF Innovations’ goal is to stimulate conception and development of products and services to generate
new revenue streams, by establishing and managing new business partnerships. Services include:
 The Innovation Team “embeds” scientist-entrepreneurs within faculty groups to provide guidance on
product ideation, intellectual property protection, regulatory practices, business case modeling,


competitive position, and path to market.
The Commercialization Team licenses technologies and products and incubates startup companies
through their capital formation and early operations. In Fiscal Years 2009-2014, WF Innovations’
industry partners had 406 invention disclosures, filed 222 patent applications, founded 19 start-up
companies, created 110 licensing and option agreements, and saw 79 patents issued to faculty and
staff. Total licensing revenue for the 5-year period exceeded $136 million.
Product Innovation & Commercialization Services manages two investment funds through its
Commercialization Pathway program: Spark Grants to enable the reduction-to-practice of innovative
ideas, and a Value Inflection Fund for achieving preclinical proof-of-concept. In 2013, WF Innovations
collaborated with over 100 faculty and staff to develop new product ideas and bolster the technology
pipeline. The Commercialization Pathway program invested over $750,000 in 16 new projects in fiscal
year 2014. WF Innovations entered into several new key partnerships in 2013, including with CHA
Health Systems in Pangyo, South Korea. CHA Health Systems includes hospitals with over 2,000 beds,
a clinical contract research organization, autologous stem cell banking, GMP stem cell manufacturing, a
medical university and commercial entities in both biotech and pharmaceutical spheres.
Contract Research and Development Services helps to structure, promote, and contract WF’s research assets
to external partners. Scientific Business Services directly manages two WF assets: the Preclinical Translational
Services unit and the Center for Applied Learning (see Sections A.4. and A.5. below). Among research assets
being currently promoted are several models of disease, pre-clinical surgical techniques, bioinformatics,
medical device testing, nanomedicine, and genetic tests.
Innovation Quarter Services is focused on the growth of the Innovation Quarter, currently home to 26 academic
entities and 50 companies. One of these companies is Inmar, a 900-employee technology company founded in
1980 that operates intelligent commerce networks. Inmar’s platforms connect offline and online transactions in
real time for leading retailers, manufacturers, and trading partners across multiple industries. Inmar is currently
partnering with WF faculty in several pilot projects. Overall, WF Innovations promotes and fosters the
development of the Innovation Quarter as a vibrant, knowledge-based community known for excellence in
science, technology, and business innovation, and supports its growth as a socially engaging environment that
will incubate and attract new companies.
A.4. Preclinical Translational Services
As a contract research organization within WF Innovations, the Preclinical Translational Services unit is
uniquely positioned to solve complex problems and achieve eventual solutions for patients more quickly and
cost-effectively. This unit provides medical device and therapeutic testing to industry and other universities, to
acquire data needed for regulatory submissions that will move forward product commercialization. Available
expertise includes a comparative medicine group with 60 years of experience and a preclinical surgical
services unit with over 30 years of experience. Preclinical Translational Services offers a broad range of
services, which include: formulation of customized experimental diets, development of animal cohorts with
specific disease states, education and training in best practices for use of animal models in research, imaging,
quality and regulatory compliance, surgical services, pathological evaluation, therapeutic efficacy testing,
medical device testing for safety and efficacy, and advice on experimental models and study design. The unit
has particular experience in using animal models to address research questions in addiction and substance
abuse, aging, cardiovascular disease, diabetes and obesity, immune competence, orthopedics, tumor biology,
women’s health, and vaccine development. Use of nonhuman primates is a special area of expertise.
A.5. Center for Applied Learning
The WF Center for Applied Learning specializes in applied and immersive learning techniques for health care
professionals, industry, government, and students. The Center supports learning needs across all disciplines,
including in-depth training to practicing clinical professionals. Curriculum goals are designed to achieve
learning outcomes that improve the quality of patient care and enhance patient safety. The Center is one of
only 43 nationwide designated as an "Endorsed Simulation Educational Program" by the American Society of
Anesthesiologists, and 1 of only 5 such programs in the southeastern United States.
At the Center for Applied Learning, learners get hands-on experience with human and synthetic tissues, highfidelity patient simulation, tabletop task trainers, and mock operating room environments. Instructors use
innovative techniques to improve patient care and safety in anatomy labs, including a surgery academy/mock
operating room, patient simulation labs, patient assessment facilities and other training environments. At the
Program for Medical Ultrasound, ultrasound experts lead courses and hands-on training sessions. The Center
arranges custom training and educational sessions, including equipment training, small group simulations,
surgical techniques, and application of medical devices. Thus, the Center plays an important role in workforce
development and in interprofessional training, key factors in the evolution to a learning health care system.
B. Human Research
B.1. Governance and Oversight
Wake Forest’s Human Research Protection Program (HRPP) provides oversight and assistance to researchers
working with human participants. The goal of the HRPP is to ensure individuals participating in research
studies are treated ethically, fairly, and are informed of any known risks posed by a study so that they can
make an informed decision about participating. In addition, the HRPP coordinates specialty reviews of certain
procedures (such as those involving radiation), and ensures that researchers have access to necessary
training and information. The HRPP is overseen by the Dean of the Medical School, the Assistant Dean for
Biomedical Research Administration, and the Director of the Human Research Protection Program and
Institutional Review Board (IRB). Some HRPP components include: the IRB, the Clinical Trials Office,
Environmental Health & Safety, Clinical Research Unit, Comprehensive Cancer Center Protocol Review
Committee, Biosafety Committee, and the Medical Radiation Safety Committee. Additional support is provided
by the Research Advisory, Research Operations, and Research Conflict of Interest Committees (all Deanappointed faculty consultative committees).
The WF IRB reviews all research involving humans to ensure participants are informed of all known risks
posed by a research study, and that these studies are conducted in accordance with the ethical standards put
forward by the Belmont Report; federal, state, and local regulations; and relevant policies governing human
research. Wake Forest has 8 Institutional Review Board panels supported by the IRB Office (Director, Joseph
Andrews, PhD). The IRB is accredited by the Association for the Accreditation of Human Research Protection
Programs (AAHRPP) and oversees approximately 2400 active studies. The IRB uses an online protocol
submission and review system (called eIRB, licensed by Click Commerce). The eIRB system provides a
collaborative workspace for the IRB and the WF human subjects research community. Principal Investigators
and their study teams can initiate new study applications, make amendments to existing studies, submit
continuing review applications and report safety events through this site. All ancillary reviews (e.g. radiation
safety and biosafety committees) are tracked through this system, expediting simultaneous review by multiple
ancillary committees when necessary and ensuring all are working with the latest/updated version of the
protocol, consent, and other application details. Each IRB panel meets on alternating weeks, equaling 16-20
convened meetings per month. The eIRB system and frequent meetings facilitate very rapid turn-around times.
The average full board turn-around times are: less than 30 days for initial applications, 13 days for
amendments, and 12 days for continuing
reviews. These times represent time for IRB
review and for study teams to address any
concerns of the IRB. In short, the IRB has
eliminated a common roadblock to clinical
and translational research – the protocol
review process – through a series of
improvements and efficiencies. The TSI also
maintains an independent Research Subject
Advocacy program offering review and safety
consultation for investigators. In addition, the
WF CTSA hub administers an institutional
Data Safety Monitoring Board (I-DSMB). This
is a Dean’s-appointed committee maintaining
a charter, operating standards, and
availability to investigators as required. The
current I-DSMB members are listed in Table
1.
B.2. Training and Monitoring
All members of the WF research community (faculty, research staff, students, adjunct faculty and visiting
researchers) are expected to adhere to the highest ethical and professional standards as they pursue research
activities, complying with all legal, regulatory, and ethical requirements established by the institutional,
regulatory bodies, funding sources and professional organizations.
All individuals conducting research at WF undergo training in the appropriate legal and ethical issues involved
in protection of human subjects. A requirement is to participate and complete the Collaborative Institutional
Training Initiative (CITI) Program, an online course to train investigators in Human Subjects regulations. This
program includes Basic Courses in the Protection of Human Research Subjects, both on an introductory and
refresher level. A multi-language course site – with materials in Spanish, Portuguese, French, Chinese, Thai,
Japanese, and Russian – is now available for international participants.
The Medical Center’s Conflict of Interest (COI) Office, in accordance with regulation 42 CFR, Part 50, Subpart
F and 45 CFR, Part 94 and state regulations, protects the credibility and integrity of its faculty, staff, and
students so that public trust and confidence in its activities are ensured. Investigators, staff, trainees, and
students conducting research at WF must complete an online COI training module annually. In addition, each
investigator must complete a COI statement to ensure that disclosure and management of potential conflicts
occur before any funds for research are released to the investigator and before any human subject research
may occur. The research component of the COI Office maintains oversight responsibility for identified research
conflicts, and requires signed management plans be in place before IRB approval of any protocol where real or
implied conflicts need to be resolved.
C. Animal Research
C.1. Governance and Oversight
The Attending Veterinarian is Richard W. Young, DVM, DACLAM. He is responsible for the welfare of all
animals used in research at WF. Personnel conduct their work in state-of-the-art facilities and are trained and
encouraged to use only the highest ethical standards in their work and the care of laboratory animals. Dr.
Young has direct or delegated authority for activities involving animals at a facility subject to the jurisdiction of
the Secretary of Agriculture of the United States or its representative. He is responsible for clinical veterinary
care and has ultimate decision-making authority regarding animal health.
All WF animal facilities meet the standards for Animal Biosafety Level (ABSL) 1 practices, equipment, and
facilities as outlined in Biosafety in Microbiological and Biomedical Laboratories (5th Edition). Inoculation
studies involving agents requiring animal BSL-2 containment are isolated and conducted using animal BSL 2
containment practices. There are no live animal studies involving BSL 3 or 4 agents at WF. Investigators using
biologic agents in research are responsible for seeing that all safety practices, equipment, and facilities are in
compliance with applicable rules, regulations, and guidelines. Before any study begins, investigators meet with
the Animal Resources Program (see C.2. below) and Environmental Health and Safety personnel to ensure
that containment and monitoring procedures are conducted in accordance with the protocol as approved by the
Biosafety Committee.
The Institutional Animal Care and Use Committee (IACUC), directed by David J. Lyons, PhD, is responsible for
the review and approval of animal activities in research and teaching, ensuring research staff are adequately
trained and protected from occupational health risks, conducts semi-annual facility inspections and program
reviews, and issues regulatory reports to external oversight organizations. The IACUC works closely with the
Animal Resources Program (see below), staff veterinarians, and researchers. In 2012, the IACUC fully
implemented an online protocol submission and review system, eIACUC, for all animal research protocols.
eIACUC, designed in collaboration with Click Commerce, also provides a collaboration workspace for the
IACUC and the animal research community. Principal Investigators and their study teams can initiate new
IACUC protocols, make amendments to existing studies, and submit continuing review applications through
this site. Protocols are reviewed monthly by the IACUC, and median turnaround time from submission to
approval averages 32 days. Expedited review processes are in place and can be implemented by the IACUC
when warranted. Amendments are reviewed continuously; amendments for personnel and procedural changes
are handled separately. Expedited review of amendments can be implemented when warranted by the IACUC.
Like the IRB, the IACUC has eliminated a common roadblock to clinical and translational research – the
protocol review process – through a series of improvements and efficiencies.
The Animal Research Monitoring & Oversight Office is responsible for quality assurance, post-approval
monitoring, the assessment of adverse events and non-compliance, and targeted training. The Laboratory
Animal Training Coordinator creates training programs and provides direct, hands-on training to laboratory,
teaching, and husbandry staff on best practices and procedures such as aseptic surgery, specimen collection,
and overall care and handling of animals used in research. An automated tracking system alerts faculty and
staff when it is time for re-certification through updated module review and testing. Credentials are verified for
all personnel listed on protocols submitted through eIACUC.
C.2. Animal Resources Program
The Director of the Animal Resources Program (ARP), Richard Young, DVM, is responsible for the university’s
laboratory animal husbandry programs. He provides oversight of veterinary care provided to research animals,
and of management of the centrally-managed housing and surgical facilities. The ARP operates in accordance
with standards and policies of the U.S. Department of Agriculture's Animal Welfare Information Center and the
Department of Health and Human Services' Office of Laboratory Animal Welfare (OLAW). Wake Forest has
been accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International
(AAALAC), since 1966. All animal research and teaching programs at WF are supported by the ARP, which
operates on an annual budget of $9.2 million (FY2014-2015; excluding capital expenditures) covering a total of
239,000 sq. ft. of facility space. The ARP employs 101 faculty and staff. The ARP provides procurement,
husbandry, and health care for experimental animals, and is a resource for scientific and technical support for
WF researchers. The ARP interacts frequently with other Institutional committees, including the IACUC, Office
of Sponsored Programs, Employee Health Services, Security, Engineering, and Facilities Planning. In FY14,
there were 437 active IACUC protocols used by approximately 141 principal investigators. The annual animal
use is approximately 42,000, representing over a dozen species.
D. Wake Forest Campuses
Research facilities are organized in four inter-connected sites: the Bowman Gray (WFBMC), Reynolda,
Downtown, and Friedberg (WF Primate Center) Campuses. These encompass more than 1 million sq. ft. of
dedicated space (see Figure 2).
D.1. Bowman Gray Campus
The primary animal facilities at the Medical Center
(Bowman Gray Campus) are (a) on the 7th floor of the
Hanes Building, (b) the 5th and 6th floors of the Nutrition
Research Center (NRC) Building (adjacent to the
Hanes Building), (c) the G and E floors of the Gray
Building (located 100 yards from the Hanes animal
facility), and (d) the MRI Building (located
approximately 500 yards from the Hanes animal
facility).
The Hanes Building animal facilities consist of 15,938
sq. ft. of space. This encompasses 5,750 sq. ft. of
animal housing space, including 13 multipurpose
animal rooms of standard design and 38 6'x6' cubicles
available for the independent housing of small groups
of animals and projects. Support and service facilities
(totaling 10,188 sq. ft.) include offices, men's and
women's dressing/shower rooms, personnel break areas, food storage, bedding and supply storage, receiving,
waste holding, cage washing, clean cage holding, pharmacy, and procedure rooms. A postoperative recovery
room and a biohazard (Biosafety Level 2) containment facility also are available.
In the NRC Building, the 5th floor NRC nonhuman primate facility has 7,268 sq. ft. of animal housing (3,631 sq.
ft.) and support space (3,637 sq. ft.). Support and service facilities include cage washing, a minor procedure
room, and nonhuman primate behavioral testing laboratories. The sixth floor NRC animal facility consists of
13,161 sq. ft. of animal housing (4,037 sq. ft.) and support space (9,124 sq. ft.). Most of this space is used to
support barrier-maintained, specific pathogen-free rodents and includes 13 holding rooms, five procedure
rooms, a mock laboratory and training room, a cage-wash facility equipped with a tunnel washer and
autoclave, and three individual storage rooms/areas for cages, food, and bedding. In addition, this space
includes six conventional housing rooms, surgery, radiology and necropsy facilities, men’s and women’s locker
rooms, and a break room. There is also a 77 sq. ft. holding area, located on the E floor of the NRC, for animals
from the time of receipt until housed in the facility on the Bowman Gray or Downtown Campus.
There is a total of 16,115 sq. ft. of animal housing (5,054 sq. ft.) and support space (11,061 sq. ft.) located on
the basement and ground floors of the Gray Building. Support and service facilities include food and supply
storage, cage washing, nonhuman primate behavioral testing laboratories, restrooms, locker rooms, and
surgery and necropsy facilities.
A 129 sq. ft. animal holding area is located on the first floor of the MRI Building at the Bowman Gray Campus.
This area consists of an anteroom (51 sq. ft.) and a housing room (78 sq. ft.) and is used to house animals
before and after PET and MRI studies.
D.1.1. The Center for Biomolecular Imaging (CBI). The CBI is a multi-technology facility comprised of stateof-the-art imaging modalities. Its purpose is to support imaging research while facilitating multi-disciplinary
collaborations. The Center was created in response to the pivotal role imaging technologies are playing in both
clinical and basic sciences research. The Center fosters an environment that provides academic growth for
faculty engaged in all areas of research. Part of its mission is to change the imaging research paradigm from
pathoanatomy to imaging opportunities related to physiologic/functional imaging and molecular imaging. The
goals of the Center are to provide new research opportunities by encouraging interdisciplinary cooperation;
supporting public and private grant-funded research; engaging in hardware and software development;
sponsoring grants for technical development and encouraging industry-funded research. The Center occupies
several spaces including the ground and first floors (13,200 sq. ft.) of the MRI building. There is an office suite
for faculty and staff, an image analysis training room, a video editing lab, plus cubicles for programmers and
analysts. There are also several large bench laboratories and multiple small bench laboratories, used for the
production of radionuclides and radiopharmaceuticals, the manufacture of MRI coils and hardware. An image
analysis lab and a cyclotron are well-equipped with current technologies. Additionally, the CBI occupies 2,000
sq. ft. in the Nutrition Research Center building and 1,500 sq. ft. in the Dean Building downtown.
Equipment consists of a 16-slice Light Speed Pro CT scanner, two MRI scanners (1.5T, 7.0T) and two PET
scanners (GE Advance NXi, Concord Micro PET), all dedicated to research scanning. Also available for
imaging research are a PET/CT scanner and a Bruker 7T MRI scanner, located in the Department of Radiation
Oncology. Downtown at the Piedmont Triad Research Park, the CBI maintains a Toshiba Aquilion 32-slice fast
whole body CT scanner dedicated to animal scanning, and a Siemens MicroCAT system dedicated for small
animal scanning. The Center houses two GE Advantage Windows workstations, which are dedicated 4dimensional workstations used for post-image acquisition data manipulation, including temporal analysis of
three-dimensional data sets. A TeraRecon workstation infrastructure and Aquarius NET Server/Thin Client
system is available for CBI users, so that every investigator can use his/her desktop as a state-of-the-art 4D
imaging workstation.
D.2. Downtown Campus
The Downtown Campus of WF, located about 2 miles from the Bowman Gray Campus, is a rapidly developing
campus in which the institution is investing substantial resources. The most recent investment is the new
Medical Education Building, a 168,000 sq. ft. building located next to the 525@Vine building (see section
D.2.5.). Transformation of a former R.J. Reynolds Tobacco Company building into a state-of-the-art
educational center is scheduled for completion in July 2016. Students will prepare for real-life educational
experiences in state-of-the-art spaces – anatomy labs, patient simulation and operating room suites, and exam
rooms with the latest informatics and patient care technologies. The building will also house student support
services, faculty offices, and meeting spaces to foster student life and mentoring. The restoration project takes
advantage of state tax credits earned from restoration of a historic property. Currently, there are extensive
research and educational activities housed in 4 different buildings in the downtown campus. The four different
buildings are the Richard H. Dean Biomedical Research Building, The Piedmont Triad Community Research
Center, Wake Forest Biotech Place, and 525@Vine and all described below.
D.2.1. The Richard H. Dean Biomedical Research Building (built in 2006) includes laboratories and offices
occupied by the Wake Forest Institute for Regenerative Medicine (WFIRM) and the Department of Pathology,
Section on Lipid Sciences. All animals used by investigators (ranging from rodents to primates) are located in
the basement, in a state-of-the-art centralized, ARP-managed animal facility. The animal facility totals 22,375
sq. ft. (8,185 sq. ft. of animal housing and 14,190 sq. ft. of support). The facility consists of a general housing
area with 17 animal rooms, and a rodent barrier facility with five animal housing rooms, one of which is made
up of five isolation cubicles. There is a surgery suite with two operating rooms, two animal preparation rooms,
one surgeon’s preparation room, and one instrument preparation room. The diagnostic imaging facility,
contains digital radiography, CT and microCT scanners, and a cobalt gamma irradiator. The facility has
necropsy and tissue preparation rooms, and a morgue cooler for carcass storage. The facility also includes a
cage wash area with a tunnel washer, a rack washer, and an autoclave. There are seven procedure rooms
located within the animal facility, 3 in the rodent barrier facility and 4 in the general animal facility. Additional
staff includes veterinary assistants, animal care technicians, and administrative support. The WFIRM also has
access to an animal core with two technicians who provide anesthesia and surgical assistance. Imaging
resources dedicated to animal studies include radiography, a C-arm unit, PET scanning, and Doppler
ultrasound.
D.2.1.1. The Wake Forest Institute for Regenerative Medicine (WFIRM). WFIRM, directed by Anthony
Atala, MD, began in 2005 to accelerate the development of new therapies in biomedical and chemical
engineering, cell and molecular biology, biochemistry, physiology, materials science, nanotechnology,
genomics, drug delivery, proteomics and medicine. Current research at the Institute focuses on a wide range of
engineered tissues with the aim of making a lasting impact on conditions ranging from congenital abnormalities
to acquired pathologies such as infection, tumors, trauma and chronic diseases. In March 2006, the WFIRM
moved to a state-of-the-art facility in the Richard H. Dean Biomedical Research Building. WFIRM includes
approximately 66,000 sq. ft. of space, distributed as follows: 40,000 sq. ft. of lab space, 22,000 sq. ft. of office
space, and a GMP facility (see next paragraph). WFIRM labs have been designed and built to support the
operational philosophy that is the cornerstone of the Institute’s multi-disciplinary research programs. The labs
are open and spacious, with no specific assignment to any single PI. All WFIRM faculty share the same space,
equipment, and personnel. Resources include molecular, cell, biomaterials, physiology, histology, microscopy,
tissue culture, bioreactor, and support cores. Over $6 million of research and support equipment is housed in
the WFIRM laboratories, and is available to every WFIRM faculty investigator. More than 60 graduate students
and postdoctoral fellows, and more than 60 collaborators from other departments also share these resources.
WFIRM scientists are currently working to create tissues and organs and develop therapeutic cell treatments
for over 30 areas of the body. The Institute received over $32 million in extramural funding in Fiscal Year 2014.
Recently, WFIRM was selected as the coordinating site for the Armed Forces Institute of Regenerative
Medicine II, a $75 million effort with 35 participating institutions nationwide. WFIRM also recently received a
major award from the Defense Threat Reduction Agency for their “Body on a Chip” project, to develop a
miniaturized system of human organs that will mimic the body’s responses to harmful agents and develop
potential therapies.
The WFIRM Clinical Center was designed and constructed to enable the production of tissue-engineered
products for evaluation in Phase I/II clinical studies. The facility is in compliance with the current good
manufacturing practice regulations (cGMP) under Title 21 Code of Federal Regulations (21 CFR) Parts 210
and 211 and with the standards of safety, identity, purity, and potency (General Biological Products Standards;
21 CFR Part 610), and other applicable regulations for biological products (e.g., 21 CFR Parts 600 through
680) and human cells, tissues, and cell and tissue-based products (current Good Tissue Practices; 21 CFR
Part 1271). The WFIRM Clinical Center, on the second floor of the Richard H. Dean Building, consists of
approximately 4,000 sq. ft. of purpose-built clean room laboratory space appropriate for aseptic processing
activities. The facility is designed for unidirectional traffic flow. Features include appropriate entry/receiving
areas for quarantine and released goods storage, and appropriate gown-in and goods-in rooms leading to an
ISO 8 (Class 100,000) area. The ISO 8 area has designated rooms for component washing and sterilization,
component preparation, and quality control activities. The ISO 7 (Class 10,000) aseptic processing area has a
gown-in room and a specifically designed pass-through for the entry of goods. Within the ISO 7 aseptic
processing area, there are four suites for cell culture and/or processing.
D.2.3. The Piedmont Triad Community Research Center (PTCRC) Building contains laboratories and
offices occupied by the WF Department of Physiology and Pharmacology and faculty from the Department of
Life Sciences at Winston-Salem State University (WSSU), an Historically Black College/University (HBCU)
(see G.2. below). All animals used by investigators in this building are housed within the PTCRC’s central
animal facility or in satellite housing areas within the building. Central (ARP-managed) animal facilities in the
building totaling 7,953 sq. ft. (3,216 sq. ft. of animal housing, 4,737 sq. ft. of support) are located on the ground
and 2nd floor, as are investigator-maintained (satellite) animal housing facilities. The PTCRC central animal
facility consists of 8 animal housing rooms, 1 of which contains 6 isolation cubicles. There also is a surgery
suite with 2 operating rooms, a radiology room, a recovery room, and separate preparation areas. In addition,
the facility has necropsy and tissue preparation rooms, and a morgue cooler for carcass storage. The facility
also includes a cage wash area with both a tunnel and a rack washer. Offices and storage areas also are
located nearby. Rodent housing and procedure space on the 2nd floor of the building consists of 2,554 sq. ft.
D.2.4. Wake Forest Biotech Place is WF’s sixth building in the Innovation Quarter, and was the largest capital
investment for a construction project in the history of downtown Winston-Salem. Biotech Place is a state-ofthe-art, 242,000 sq. ft., biotechnology research and innovation center designed to allow more growth for WF’s
research departments, create incubator space to promote start-up companies generated by researchers'
discoveries, and include space for established biomedical research companies. The first floor houses
laboratories and offices occupied by the Childress Institute for Pediatric Trauma and the WF Departments of
Microbiology/Immunology, Biochemistry, Physiology/Pharmacology, and Biomedical Engineering. The latter
department is the WF academic home of the joint WF-Virginia Tech School of Biomedical Engineering, and
has state-of-the-art classrooms for virtual sessions between the two campuses. The building is also the home
of WF Innovations (described above in section A.3).
All animals used by Biotech Place investigators are housed in a centralized facility (over 18,700 sq. ft.)
managed by the WF Animal Resources Program. The facility consists of a general housing area with 7 animal
rooms, a rodent barrier facility with 3 animal housing rooms, and a BSL-2 facility housing rodents in 11 animal
housing rooms with 3 associated procedure rooms. The facility also includes a VetEquip Rodent Anesthesia
Machine and Vaporstick, and a cage wash area with 2 rack washers and 2 autoclaves. A veterinary treatment
room is also located within the vivarium, along with staff offices and storage space.
Each room in the animal facility is monitored with a Watchdog System (Edstrom, Waterford, WI). This system
provides constant monitoring of environmental conditions, including air pressure differentials, temperature, and
humidity. The system produces reports for quick and easy evaluation of conditions, and helps pinpoint any
issues. Edstrom’s Viewport System is active in all animal housing rooms to document tasks performed during
upkeep and management of the vivarium.
All mice, rats, and larger rodents (chinchillas) are housed in ventilated caging with direct external exhaust.
Racks are HEPA-filtered both on air intake and exhaust. All racks, cages, tops, bedding, wire bar lids, and
water battles are autoclaved into barrier and ABSL-2 housing areas. Immunocompromised mice are fed
irradiated feed. Non-barrier mice are also housed in ventilated caging.
A necropsy suite consists of two rooms encompassing 252 sq. ft. of space, including an anteroom for gowning
and supply storage. The necropsy area consists of 2 updraft necropsy cabinets/ laminar work bench suitable
for rodent and small animal necropsies. A ventilated closet is available for storing formalin and other hazardous
chemicals. The laminar work bench and hazardous agent storage closet are vented directly to the outside;
exhaust air is not filtered. The necropsy, tissue preparation, and gowning areas are constructed using epoxypainted concrete block and have seamless epoxy floors. The entire suite is supplied with 100% fresh air and is
under negative air pressure relative to adjoining areas.
D.2.5. 525@Vine. The newest WF building in the Innovation Quarter, 525@Vine, is next to Biotech Place.
Originally built in 1926 as a tobacco blending processing plant for R.J. Reynolds, the facility has been
redeveloped and revitalized in accordance with historical preservation guidelines to become a 234,000 sq. ft.
state-of-the-art research facility containing offices, wet labs, and collaborative space. The facility includes
environmentally friendly building design and operation, designed to Leadership in Energy and Environmental
Design (LEED) Gold standards. The 525@Vine building houses all 3 Departments of the Division of Public
Health Sciences (see following paragraphs), the WF Physician Assistant Program (see section J.2.); a YMCA
branch; and space for several entrepreneurial companies. The building’s newest tenant is Forsyth Technical
Community College’s Center for Emerging Technologies, a 24,000 sq. ft. facility which will eventually train
1,200 students annually. Forsyth Tech is nationally recognized for its workforce development education in
biotech fields.
D.2.5.1. The Division of Public Health Sciences. The Center for Prevention Research and Biometry was
founded in 1986 as evidence of the school's commitment to programs in prevention research. It is now the
Division of Public Health Sciences, created February 1, 2006, and directed by Gregory L. Burke, MD, MS. The
Division's overall goals are to further research programs in biostatistics, epidemiology, nutrition, and health
promotion/disease prevention, and to strengthen research at the school by providing consultation in the
development of research proposals, study design, analysis, and other methodological issues. The Division is
divided into three departments: a) Biostatistical Sciences, b) Epidemiology and Prevention, and c) Social
Sciences and Health Policy. Through the Wake Forest University Graduate School, the Division offers an MS
degree in Clinical and Population Translational Science (see section J.). This program is especially targeted to
the training of physicians and postdoctoral fellows.
The Division has ongoing programs in cardiovascular disease, nutrition, diabetes, renal disease, osteoporosis,
cancer control, aging, women's health, community interventions, health-related quality of life outcomes, and
adolescent health research. It also serves as the Coordinating Center for many multicenter studies. The
Research Computing Unit (part of the Department of Biostatistical Sciences) specializes in state-of-the-art
research computing methodology.
D.2.5.2. Department of Biostatistical Sciences (Chair, Walter Ambrosius, PhD). The Department of
Biostatistical Sciences provides expertise in biostatistics, clinical trial design and conduct, computer
programming, and advanced research data processing services. The 25 faculty in the Department conduct
methodological research in survival analysis, sequential analyses, clinical trial design, categorical data
analysis, analyses with missing data, assurement/misclassification errors, multivariate/longitudinal analysis,
resampling techniques, robust regression, meta-analysis, psychometrics, regression diagnostics, quantitative
epidemiology, genetics methods, and health service methods. The Department promotes basic, clinical, and
epidemiological collaborative research of the highest methodological standards for design, conduct, and
analysis.
Faculty and staff collaborate with investigators on: study design, remote or centralized data entry systems,
data management, quality assurance, data analysis, development of new statistical methods, sample size
calculations, surveys and questionnaire development, publications, and manuscript reviews. The Department
provides training in scientific programming, data systems design and management, and networked
communications. The Department's programmers, biostatisticians, and staff (N=100 total) work closely
together to integrate strict quality control specifications in the design of data management systems. Faculty
and staff in the Department have been jointly involved in the design and development of many computerized
data systems. This combination of experience and collaborative spirit places us as a national leader in the
coordinating of large multicenter studies.
D.2.5.3. Department of Epidemiology and Prevention (Chair, Alain Bertoni, MD, MPH). The Department
includes 12 full-time faculty and 55 staff. The Department’s faculty research includes cardiovascular disease
epidemiology, diabetes epidemiology, the epidemiology of aging, cancer control, cancer epidemiology,
demography of aging, genetic epidemiology and nutrition. There is also a focus on clinical trials methodology;
the Department houses both coordinating centers and clinical centers. Faculty have extensive experience with
large, multicenter studies and regularly collaborate with clinicians and basic scientists throughout WF.
D.2.5.4. Department of Social Sciences and Health Policy (Chair, Douglas Easterling, PhD). The
Department has 15 full-time faculty members and 43 staff. Faculty members have expertise in health-related
quality of life, prevention of substance abuse, medical effectiveness, health care outcomes research,
psychosocial factors in health and disease, prevention of adolescent high-risk health behaviors, women's
health issues, community interventions, and cost-effectiveness analysis of medical treatments. Members of this
Department have headed or participate in multicenter studies of cardiovascular disease, dementia, breast
cancer, and hypertension.
D.3. Reynolda Campus
The Reynolda Campus is home to WF undergraduate degree programs, and the WF arts and non-biomedical
sciences graduate programs. The Reynolda Campus animal facility encompasses 1,700 sq. ft. The facility
includes housing space, much of which is managed by investigators (satellite facilities). Support space
includes restrooms, a cagewash area, and storage areas for food, bedding and supplies; and outdoor housing
for research animals, kept in a secure area surrounded by cyclone fencing.
D.3.1. The Translational Science Center (TSC). The goal of the TSC (Daniel Kim-Shapiro, PhD, Director) is
to bring together multi-disciplinary faculty to build internationally recognized research programs, and first-rate
academic training programs The TSC was formed in 2009 through an internal competition on the Reynolda
Campus, in which faculty competed for funds to establish interdisciplinary programs. The faculty of the TSC
has grown from 14 to 44, representing from multiple departments on the Reynolda Campus, the WF School of
Medicine, Winston-Salem State University, and other collaborating institutions. The TSC’s institutional support
was renewed in 2014 for another 5 years.
The TSC’s focus is on research to translate basic discoveries in the lab to clinical practice that improve
functional health in aging. The TSC holds a monthly faculty meeting that features a research talk by a member.
These meetings foster establishment of interdisciplinary research teams that conduct TSC-sponsored pilot
research. The TSC has worked closely with the Translational Science Institute to align pilot funding
opportunities for better cross-campus integration of multidisciplinary research and has been represented on
WF leadership committees in clinical and translational research initiatives. So far the TSC has funded
$460,000 for pilot projects; these have led to $1.8 million in external funding with ties to the TSC pilot program.
Current pilot studies supported by the TSC examine how nitrate administration (delivered as beet root juice)
can benefit patients with congestive heart failure, chronic obstructive pulmonary disease, and stroke.
Faculty from both campuses can join the TSC. In past cases where both the Translational Science Institute
and TSC found pilot research proposals to be meritorious and consistent with their individual missions, pilots
have been jointly funded to leverage resources. In some cases, research-associated regulatory costs can be
shared. Finally, both groups co-sponsor seminars and workshops of common interest, and work to bring
expanded research opportunities to WF undergraduates.
The TSC also has an educational component, designed to introduce translational science concepts to WFU
undergraduates. Every WF freshman must enroll in a multidisciplinary First Year Seminar. In spring 2015, we
will offer “Explorations in Translational Science” (Gary D. Miller, Course Director) as one of these seminars, to
explore fundamental processes in translational science and discuss inherent challenges. Examples of
translational science will include those related to aging, sickle cell disease, and cognition. The course will span
Biostatistics, Chemistry, Geriatrics, Health & Exercise Science, Neuroradiology, Physics, Physiology and
Pharmacology, and Psychology, and will include some practice in conducting translational research.
D.4. Friedberg Campus
The Friedberg Campus, home to the Wake Forest Primate Center and many faculty in the institutionallysupported Center for Comparative Medicine Research (both directed by Jay Kaplan, PhD), is a 200-acre
developed site located 10 miles south of the Bowman Gray Campus. Animal housing and support space total
94,709 sq. ft., including 15 housing units for nonhuman primates, six fly pens for pigeons, facilities for housing
rodents, two barns for housing sheep, a cage-washing facility, offices, and other support areas.
D.4.1. Wake Forest Primate Center. The Primate Center has been home to the faculty of the Section on
Comparative Medicine since the mid-1960s. Comparative Medicine faculty have helped pioneer the use of
nonhuman primates in biomedical research. The Center’s primary functions are research, training, and
outreach. Investigators at Wake Forest currently use nonhuman primates to study 7 of the 10 major causes of
death in the United States. Our training effort includes programs designed to teach both pre- and postdoctoral
veterinarians how to conduct biomedical research. The grant that supports the postdoctoral activity is currently
in its 55th consecutive year of funding. Starting 25 years ago, the Center began training veterinarians and
other scientists from Bogor Agricultural University in Indonesia, and in doing so helped establish the
Indonesian Primate Center. Our collaborative Indonesian training program in primate medicine and biology
remains active, with numerous PhD students and postdoctoral fellows on-site at any time. The Primate Center
has also made its outreach program a priority, and these extensive activities serve both scientists and the lay
community. Scientific outreach extends to investigators throughout the institution and nationally who require
expertise, infrastructure, and monkeys for studies that advance human health and well-being.
D.4.2. The Data Services Unit (DSU). The DSU supports all research and animal care activities on the
Friedberg Campus and is responsible for the management, archiving, and security of all clinical and research
data derived from the animals housed at this location. The unit is staffed by 13 individuals, including
programmers, web developers, hardware technicians, research methods specialists and data entry experts.
The DSU has the Primate Information Retrieval System and RS/1 as its primary software tools for fulfilling its
obligations to researchers and clinicians. The Primate Information Retrieval System (PIRS) is a computerized
database system established in 1975 to maintain the experimental, clinical, pathologic and demographic data
for all nonhuman primates in our colonies, past and present. PIRS allows storage, processing and retrieval of
information concerning an individual animal or a group of animals. The system contains vital information
consisting of over 2,500,000 records on approximately 17,000 animals presently and formerly at the facility.
Access to the system is available to all on-site users and authorized staff members. Users can request the
transfer of selected PIRS data into Excel and/or RS/1 for analyses and graphics. All data are up-to-date and
available for on-line access daily via a web interface.
The software used in the management of these data is ORACLE. It has been used by the DSU over the last 20
years to coordinate colony management data and some research data. This software can program data entry
screens and perform range checks upon entry. RS/1 provides a built-in interface to ORACLE to allow easy
transfer and access to data. Data entry and correction procedures are consistent, regardless of which software
package is used during DSU processing. Collection and storage of data on nonhuman primates begin with the
arrival of animals into our colonies either through acquisition from outside sources or birth at our institution. All
important events from that time on are recorded such as origin, birth date, parentage, location, diet, illnesses,
diagnostic tests, therapeutic interventions, experimental analyses and experimental manipulations. Data are
categorized as informational, clinical, research or surveillance. Data collection continues until the animal is
transferred to another institution or dies. Results of necropsy examinations on all primates are also stored in
our computerized record system.
D.4.3. Vervet Research Colony. This NIH-supported national resource (P40 OD10965; PI: Kaplan) consists
of approximately 350 vervet or African green monkeys (Chlorocebus aethiops) living in 16 breeding groups.
The Vervet Research Colony (VRC) was transferred from UCLA to the WFSM in 2007. It was initially founded
in 1975 with 14 vervets captured from St. Kitts, West Indies. Between 1976 and 1985, 43 wild caught animals
were added. The current population of the VRC includes descendants from the 57 original founders (29
females, 28 males), with 24 of the original matrilines now in their 3rd to 7th generation. Colony management
practices reflect the natural social composition of vervet monkey groups in the wild. Housing consists of 16
enclosures with 1000 sq. ft. of outdoor and 300 sq. ft. of indoor space, each containing one breeding group.
Infants and juveniles remain in the natal group with their mothers and female kin. Males are removed at
adolescence and transferred to other groups, and adult males are rotated between groups at 3-4 year
intervals, to mimic the natural processes of emigration and immigration. The colony is managed to maintain
genetic variability, avoid inbreeding depression, and promote long-term viability of the population. All colony
animals have been genomically sequenced.
E. Informatics/Information Technology Platforms
E.1. The Translational Data Warehouse
The Translational Data Warehouse (TDW) provides a comprehensive research data warehouse integrating
patient information from multiple sources, including electronic health records, laboratories, and research
datasets. This information is aggregated, cleaned, and de-identified before presentation to the user, who will
then be able to query the data using the data warehouse application. The TDW is based on the open source
software called Informatics for Integrating Biology and the Bedside (i2b2), an NIH-funded National Center for
Biomedical Computing (NCBC) project based at Partners HealthCare System. The i2b2 NCBC has developed
a scalable informatics framework to bridge clinical and basic science research data in order to better
understand the genetic basis of complex diseases.
The architecture consists of infrastructure that takes care of security, access rights and managing the
underlying data repository, and an application suite of query and mining tools that allows users to ask
questions about the data. This powerful tool allows investigators to conduct exploratory research with a rich
dataset while maintaining strong protection of patient privacy. Researchers initially use the tool to identify the
number of potential research subjects available, the feasibility of retrospective reviews, and potential for further
recruitment once a potential sample is identified. IRB approval is not required for preliminary TDW searches.
Researchers can select desired inclusion and exclusion criteria, such as dates, procedures, diagnoses, labs,
medications and demographics, to meet the needs of the study being considered. In return they will receive the
number of patients meeting those criteria. Full identifiers are not provided for exploratory searches, only the
number of patients in the medical record who meet the search criteria.
Researchers may submit an IRB application to request identifiers for the set of results received from the TDW.
Once IRB approval is obtained, the researcher can request that the TDW Data Control Agent link those
identifiers to the data set so that the IRB-approved research can commence. The identifiable data are provided
to the researcher with protections as approved by the IRB. This tool accelerates feasibility analyses for
sponsored studies being considered. The TDW currently contains de-identified clinical data for more than 2.1
million unique patients for over 17 million visits. This includes more than 1 billion observations of
demographics, vital signs, diagnoses, procedures, labs, and medications. TDW is updated with a feed from the
medical record system periodically.
E.2. Electronic Health Records (EHR) System
In 2012, WFBH transitioned to an EHR system created by Epic and known as WakeOne®. It is a single,
enterprise-wide platform that supports integrated clinical, billing and ancillary applications. Data, such as
medication lists and treatment history, flow between providers/departments, eliminating the need for multiple
data entries. Features allow patients to establish accounts to view their laboratory and other test results online, contact their providers electronically, and make or change appointments. We have successfully tested
authorized exchanges of patient information with other Epic-based systems in our region, including Duke
University Medical Center. This leads to better service, improved patient safety and satisfaction, reduced time
and labor, more accurate billing, and will extend beyond clinical delivery to all support services in the near
future. The EHR is part of a strategic effort to standardize data definitions, consolidate storage, streamline
reporting, and provide managers clear, current and comprehensive medical information for better decisionmaking.
In addition, WakeOne® will greatly enhance and streamline the process of integrating research data in the
approximately 730 active clinical trials involving more than 11,000 patients at WFBH. WakeOne® and a new
clinical research management system (CRMS) implemented in 2013 now promote more consistent
documentation of research notes in patients' medical records; enhanced scheduling, tracking, and invoicing;
and facilitate audits and compliance checks. WakeOne® includes a simple check box to flag the records of
patients who are part of research studies, and has features to help identify candidates for clinical trials by
prescreening patients for inclusion and exclusion study criteria, with automated notification of study
coordinators. Ultimately, the WakeOne® EHR system will improve and enhance the capabilities and efficiencies
of research as well as patient care at WFBH.
E.3. Research Electronic Data Capture (REDCap)
REDCap is hosted at WF through the Translational Science Institute. The REDCap system provides secure,
web-based applications for a variety of types of research. REDCap provides an intuitive interface for users to
enter data and have real-time validation rules (with automated data type and range checks) at the time of
entry. Data entry can also take place at a multi-institutional level for a single project. This system offers easy
data manipulation with audit trails and reports for reporting, monitoring, and querying patient records, and an
automated export mechanism to common statistical packages; the iterative development and testing process
results in a well-planned data collection strategy for individual studies. REDCap was implemented at WF
specifically around HIPAA security guidelines and currently operates three separate platforms: internal,
external, and a separate platform for the Comprehensive Cancer Center. User logins are tied to an individual’s
medical center ID and authenticated across platforms. Additionally, REDCap is flexible for external
collaborators allowing ease of use for cross-institutional affiliates. Individuals outside of the Wake Forest
security system are provided a unique authentication.
A comprehensive list of institutional systems, software, and tools is included in Table 2.
F. Infrastructure That Supports Research In Aging
F.1. Sticht Center on Aging
The Sticht Center on Aging was founded in 1987 by William Hazzard, MD to coordinate all of the clinical,
educational and research activities in gerontology/geriatrics at WFBH. The J. Paul Sticht Center on Aging and
Rehabilitation building was constructed with a $40 million investment in 1997 and serves as the hub of
research and teaching activities as well as a key location in the clinical treatment of elderly patients. This four
story, 150,000 sq. ft. building houses geriatric outpatient services, geriatric psychiatry, geriatric rehabilitation,
the Acute Care for the Elderly unit, administrative and faculty offices, several conference rooms, the Roena
Kulynych Center for Memory and Cognition, the Geriatric Research Center, and a TSI Clinical Research Unit
Geriatric satellite site that opened in 2002. In September 2006, the Aging Center program was designated as
an official university-wide center by then-Dean William Applegate (a geriatrician; Physician Champion in the
Integrating Special Populations program) with Dr. Stephen Kritchevsky as its first director. This designation
entails the provision of institutional dollars to support the development and coordination of research programs
of relevance to aging at WFSM. Dr. Barbara Nicklas is Deputy Director of the Aging Center, and Dr. Jeffrey
Williamson (Section Head of Gerontology/Geriatric Medicine) is Director for Clinical Research. The Center’s
membership includes 89 scientists from 22 departments and sections across the university. The total amount
of extramural funding in FY14 to Aging Center members exceeds $40 million. This large inventory of active
funded research in aging provides extensive resources and a productive training environment for trainees.
F.1.2. The Aging Center supports the Geriatric Research Center (GRC), site of the Clinical Research Core
for the WF Claude D. Pepper Older Americans Independence Center. This is a 4,000 sq. ft. facility for state-ofthe-art body composition analysis, exercise training, exercise stress testing, echocardiography, strength and
functional status testing, as well as facilities for metabolic studies. The GRC also includes a reception/waiting
area and seven private offices. Six wheelchair-accessible examination rooms are located on the ground floor in
the outpatient clinic area. These examination rooms are currently used for both clinical research and patient
care. In addition, a standard examination room is located on the first floor within the GRC area. The
Cardiopulmonary Laboratory, a 420 sq. ft. facility located in the GRC, is equipped with a Trackmaster treadmill,
12-lead ECGs, a Medgraphics expired gas analysis system, lockable storage, and automated and manual
blood pressure gauges. Facilities for blood collection, processing and storage include a refrigerated centrifuge
and a -80°C freezer. Additionally, the lab is equipped with a fully stocked crash cart, and practice codes are
conducted with GRC staff every other month. A physician is on call during each stress test for safety. There
are eight treadmills located in the GRC for use in exercise training studies. Physical performance tests
supported by the center include the Short Physical Performance Battery, grip strength, a variety of
questionnaire-based assessments, including the PAT-D disability questionnaire. Our 400m walk tests are
conducted in a low-pile carpeted hallway, 128.5 ft. in length, just outside the main entrance to the GRC. There
are cones at either end of the hallway that participants must walk around to complete a lap. There are chairs at
either end for use if the participant becomes fatigued and for post-testing. The GRC is also equipped with a leg
extension power rig, a Biodex computerized robotic dynamometer, and a GAITRITE electronic walkway.
F.1.3. The Roena B. Kulynych Center for Memory and Cognition Research (Director, Jeffrey Williamson,
MD, MHS). The mission of the Center is to support research in dementia and memory loss from the
perspective of geriatricians. The Center focuses on the prevention of progressive illnesses by proactively
promoting geriatrician-specific research. Its purpose is to find new and improved methods identifying older
adults at high risk for dementia and to design treatments for preventing physical disability at an early stage in
their disease. In addition, the Center will develop better ways for understanding specific patterns of memory
loss and the appropriate medication and other behavioral forms of treatment that would best treat specific
types of memory impairment and their associated complications. A central goal of the Center is to translate
new knowledge about preventing and treating memory loss from the research setting to the patient. It partners
with the Pepper Center and the Laboratory for Complex Brain Networks to examine the role of brain networks
in the link between obesity and physical function. In 2013, Drs. Suzanne Craft (KL2 Mentor) and Laura Baker
joined the Kulynych Center to form a new research program specifically focused on Alzheimer’s disease.
F.1.4. The Section on Gerontology and Geriatric Medicine has 26 full-time faculty members. Clinical
activities include an outpatient geriatric consult clinic, an outpatient memory assessment clinic, a home care
program, an Acute Care for the Elderly inpatient unit, the Brookridge Assisted Living and Nursing Homes, and
a clinical geriatrics fellowship program. In 2008, WFSM was designated as a John A. Hartford Center of
Excellence (HCoE, Dr. Williamson, PI). The goal of this program is to expand the recruitment of medical
students and residents and fellows into careers in academic geriatrics and gerontology by introducing them not
only to geriatric clinical care, but also to clinical research through the systematic inclusion of information about
research opportunities for student and resident trainees in every clinical lecture given by faculty in the Section.
The Center recruits new faculty who are outstanding clinicians with high interest and promise for academic
geriatrics and supports the career development of these academic geriatricians who have demonstrated
leadership potential as clinician scientists or clinician educators. Currently the HCoE at WF supports five
scholars. Wake Forest also received a Donald W. Reynolds Foundation (DWRF) Geriatrics Education Program
award in 2009. The DWRF program is focused on the translation of evidence-based knowledge in geriatrics
and gerontology to the bedside teaching to the spectrum of trainees throughout the entire institution. Thus, our
Geriatrics Section has the clinical resources, patient population, and a core faculty of geriatricians to provide
resources and strong support for the conduct of clinical research in the aging population.
G. Regional Academic Partners
G.1. North Carolina Agricultural &Technical State University (NC A&T)
North Carolina A&T State University graduates the nation’s largest number of African American engineers at
the undergraduate, masters and doctoral levels as well as psychology undergraduates. The School of
Business and Economics, is also among the largest producers of African American certified public
accountants. NC A&T is home to the largest agricultural school among historically black colleges and is the
nation’s second largest producer of minority agricultural graduates.
Research at NC A&T is conducted within the 7 schools and colleges, the Joint School of Nanoscience and
Nanoengineering (JSNN), and in interdisciplinary research centers. Most of the university's research is
organized into nine research clusters --multi-disciplinary areas in which A&T focuses its research resources.
Major projects include collaborations with other universities, such as the National Science Foundation
Engineering Research Center for Revolutionizing Biometallic Materials, and interdisciplinary projects within the
university, such as the Center for Excellence in Post-Harvest Technologies.
The JSNN is a collaboration between NC A&T and the University of North Carolina at Greensboro. NC A&T
faculty members in the Department of Nanoengineering and affiliated faculty members from departments
across campus conduct research and work with graduate students in degree programs leading to MS and PhD
degrees in nanoengineering. The JSNN is located at the South Campus of Gateway University Research Park,
another major joint collaboration between the two universities. The JSNN is housed in a state-of-the-art
105,000 sq. ft. facility, with extensive labs and clean rooms. Gateway University Research Park and JSNN
have partnered with leading manufacturers of tools that are critical to exploring the frontiers of nanoscience
and nanoengineering. JSNN faculty and students have access to a sophisticated suite of tools including the
only Carl Zeiss helium ion microscope in the Southeast. The JSNN provides an environment conducive to
commercialization of university-developed intellectual properties and creates a space to facilitate
industry/academic collaborations.
G.2. Winston-Salem State University (WSSU)
WSSU, founded in 1892, is a constituent institution of the University of North Carolina, and is a historically
black university that offers baccalaureate and graduate programs to a diverse student population. WSSU has
consistently been ranked among the Top Public Comprehensive Colleges in the South - Bachelor's Category
by U.S. News and World Report. WSSU offers over 40 undergraduate programs and 10 graduate programs
with an enrollment of 6,333 students.
Department of Life Sciences: The Department of Life Sciences was established in 1971 as part of the College
of Arts and Sciences. The basic science laboratories consist of approximately 1000 sq. ft. of laboratory space
as well as most of the necessary equipment for a functional core laboratory. Six faculty laboratories are located
on the 1st and 4th floors of the Wilveria Bass Atkinson Science building. Shared instrument rooms, a conference
room, and a room for a computerized densitometry system for data analysis of autoradiograms and microscopy
are located in the same building. Individual laboratories are available for 6 faculty from the Department of Life
Sciences in the Piedmont Triad Research Community Center (PTCRC) building, within the Wake Forest
Innovation Quarter. The building is shared with the WF Department of Physiology & Pharmacology with
approximately 60,000 sq. ft. of total space. The animal facilities are located in the same building and adjacent
to the laboratories. The facilities are under the direction of the WF Animal Resources Program, and the
facilities are fully AAALAC-accredited.
The School of Health Sciences is located in the FL Atkins Building, which currently house the School offices,
the nursing department, and the clinical laboratory science department. This 70,305 sq. ft. building houses the
physical therapy, health care administration, and occupational therapy departments. The building contains a
lecture hall with video conferencing, a computer lab with 64 units, a research center for faculty, a
teleconferencing center and full laboratories and skills labs for each department. All offices, classrooms and
teaching areas are equipped for internet and cable television. There are computer labs, skills practice labs, and
clinical laboratory science diagnostic labs available for student practice and faculty research. The
University/Community Wellness Center has a diagnostic lab where selected laboratory tests can be run.
Physical Therapy Department: WSSU has a progressive history of incorporating innovative technology into
professional program curricula to support both the education and research training of physical therapy
students. Faculty members continuously attend training workshops to support the implementation of advanced
technology in the classroom and research laboratory. The Doctor of Physical Therapy curriculum is built
around an applied learning educational approach. This approach includes the use of community clinic learning
labs, computer-aided human patient simulation, medical gaming, and virtual reality along advanced technology
for the assessment of human motion. Departmental faculty received a provisional patent for a partial task
trainer simulator used to educate students and practicing clinicians about pressure ulcers.
Virtual Hospital: The Department of Physical Therapy, in collaboration with the School of Health Sciences, has
established a 4000 sq. ft. Virtual Hospital. The facility provides support for conducting interdisciplinary patient
care scenarios involving physical therapy, occupational therapy, nursing, health management and clinical
laboratory science students. In collaboration with the WF Department of Physiology and Pharmacology,
doctoral students in Physical Therapy also participate in basic medical science simulations that require
application of complex physiological and pharmacological concepts that are essential for the competent and
safe practice of physical therapy. The Virtual Hospital contains two digital classrooms, one with a traditional
lecture hall orientation and another built for small group interactive learning. Both rooms have digital
technology that allows the viewing of live or pre-recorded simulation learning experiences. Through the METILearning Space (see below), experiences are available via the Internet to clinical learning partners. The VH
also houses a medical records office, intake desk with waiting room, rehabilitation apartment, two private
patient simulation rooms, two large suites for housing group simulations, and a central control room with glass
windows for viewing the simulation suites. A functioning clinical laboratory station is also incorporated into the
Virtual Hospital. Nine flat panel monitors are located within each of the described spaces for the display of
patient monitoring information such as ECG rhythms.
The VH houses seven human patient simulators. Six of these simulators are high-fidelity, computer-aided
mannequins that produce human-like physiological responses to virtually administered medications or
programmed illness including various heart rates and rhythms, breath sounds, bowel sounds, seizures,
sweating, bleeding, and urinating. One simulator is a mid-fidelity simulator used in cardiopulmonary
resuscitation training. The Virtual Hospital also has two moulage kits to simulate burns, fractures, eviscerations
and open wounds. Through hydraulic connections, the simulators may be programmed to bleed and produce
“venous ooze” or an “arterial squirt”. The simulators are housed in advanced medical beds and on support
services similar to those in an actual hospital. Wall mounts also simulate room oxygen, suction, and lighting,
while flat screens display patient vital signs.
Through the METI Learning Space software, simulation experiences may be recorded and stored for later
viewing. Grade book features including notation of timed responses and selection of individual student
performance can be archived. METI Learning Space software also allows faculty to use previously created
simulation patient scenarios and to export both live learning experiences and archived experiences to clinical
training partners. These simulations can be exchanged between WSSU and Wake Forest. Mac computers are
used to program the simulators and four individual servers control the METI-Live Software and the digital
cameras placed throughout the hospital.
WSSU and WF Human Performance and Biodynamics Laboratory: The WSSU and WF Human Performance
and Biodynamics Laboratory is located in the Piedmont Plaza Building near the WFBH main campus. This
well-equipped, 2,000 sq. ft. state-of-the-art human movement lab contains the newest equipment to monitor
and measure human movement of all kinds. The lab is a collaborative training facility for Doctor of Physical
Therapy students, WF postdoctoral students from Biomedical Engineering, medical students, and residents
and fellows from the Department of Orthopaedic Surgery. Faculty of the various disciplines conduct joint
research in areas of interest. Equipment includes a 10-camera motion analysis system, four force plates
mounted flush into the floor, a NeuroCom dynamic posturography equipment and computer, 16-channel
electromyography unit, a video immersion virtual reality system, a GaitRite walkway with computer, Novel
Pedar in-shoe and mat pressure systems, and a metabolic cart allowing for the measurement of oxygen
consumption during activities. There are also two office spaces (each ~ 100 sq. ft.) with three desktop
computers and software for data entry and analysis, along with four graduate student cubicles and a research
participant changing room.
G.3. Appalachian State University (ASU)
Appalachian State University (ASU), 1 of the 26 universities in the University of North Carolina system, is
located in Boone, NC, about 90 miles west of WF. ASU enrolls approximately 17,000 students and offers over
150 undergraduate and graduate majors. The College of Health Sciences began in 2010 and has 20 distinct
programs of study organized in the departments of Nursing; Social Work; Communication Sciences and
Disorders; Nutrition and Health Care Management; Health and Exercise Sciences; and Recreation
Management and Physical Education. There are currently close to 1,800 student majors in these programs.
The Wake Forest Physician Assistant Program now includes slots for up to 32 students at ASU. Accreditation
for the ASU campus was granted in September 2013, and the first students enrolled in June 2014. The Boone
campus has also been approved by the Southern Association of Colleges and Schools (SACSCOC).
G.4. University of North Carolina at Greensboro (UNCG)
UNCG is a public, coeducational, doctoral-granting university in the UNC system. UNCG has an enrollment of
18,000 students offering more than 100 undergraduate, 61 masters, and 16 doctoral programs.
The UNCG School of Nursing offers nursing programs at the BSN, RN-BSN, masters and PhD levels, both on
campus and outreach areas in Hickory. It also co-sponsors anesthesia schools at WF and Duke. Students can
have clinical experiences in over 500 agencies statewide. The School supports four nursing clinics for the
elderly and/or disadvantaged as educational sites for students, made possible by strategic community
partnerships. The UNCG School of Nursing was named a Center of Excellence by the National League of
Nursing for the third consecutive term, 1 of only 3 nursing schools nationwide with this designation. The School
was re-accredited by the National League of Nursing in 2012 for an 8-year term.
The UNCG School of Health and Human Services offers bachelors, masters and doctoral programs in
Communication and Science Disorders, Community in Therapeutic Recreation, Public Health, Kinesiology,
Social Work, Nutrition, Conflict and Peace Studies, Genetic Counseling and Gerontology. These programs
work with the College of Nursing and collaborate with many WF departments.
The Center for Natural Products and Drug Discovery Research, a division within the Department of Chemistry
and Biochemistry, has the mission to create new knowledge regarding drug discovery, as well as computerbased methods used in drug design, and to disseminate this information to students, scientists, and the public
through education, training, and research. New and existing methodologies are applied to design and prepare
potential drug candidates. The Center serves as a resource for local pharmaceutical and biotechnology
industries, helping to foster and maintain strong university-industry relationships and collaborations.
G.5. Virginia Polytechnic Institute and State University (Virginia Tech)
Virginia Tech is a public land-grant university with the main campus located in Blacksburg, Virginia. The
university is comprised of 8 colleges and graduate schools, 65 bachelors’ degree programs, and 150 masters
and doctoral programs with 31,000 full-time students.
The Virginia-Maryland Regional College of Veterinary Medicine (VMRCVM) is built upon two of the nation's
leading land-grant universities: Virginia Tech in Blacksburg and the University of Maryland at College Park.
The College operates three campuses: at Virginia Tech, the Avrum Gudelsky Veterinary Center at College
Park, and the Marion duPont Scott Equine Medical Center in Leesburg. The VMRCVM offers comprehensive
educational programs, provides advanced clinical care for clients throughout the region, and conducts animal
and biomedical research, some in collaboration with the Comprehensive Cancer Center at WF.
A unique feature of our graduate program is the Virginia Tech – Wake Forest University School of Biomedical
Engineering and Sciences (SBES). By having campuses in Blacksburg (Virginia Tech) and Winston-Salem
(Wake Forest), this school unites the resources of WF with those of Virginia Tech Colleges of Engineering and
Veterinary Medicine and provides exceptional opportunities for research and education. SBES offers the PhD
and the MS degree in Biomedical Engineering. Specialty tracks include biomedical imaging, biomechanics,
tissue/ material engineering, and medical physics. Course are taught on both campuses and available to
students on both campuses via videoconferencing.
G.6. W.G. Hefner VA Medical Center (VAMC)
The W.G. Hefner VAMC, one of the fastest-growing VA centers nationwide, is located in Salisbury, NC and is a
member of the Eastern Veteran’s Rural Health Resource center. The Hefner VAMC is a Level 1C Tertiary Care
Rural VAMC with over 92,000 enrolled veterans (see letter of support from Dr. Robin Hurley). Its mission is to
develop and evaluate innovative practices and evidence-based policies to improve health of veterans. Primary
and secondary health care are available to over 258,000 veterans in a 24-county area within NC, with clinics in
Charlotte, Hickory, Salisbury, and Winston-Salem. The Hefner VAMC has third-and fourth-year WF medical
student rotations across a wide-range of disciplines. Inpatient services include internal medicine, cardiology,
surgery, psychiatry and physical medicine and rehabilitation, and on-site sub-acute and extended care
facilities. The Hefner VAMC affiliation with WF includes VAMC residency training in Psychiatry, Primary Care,
Ophthalmology, Infectious Diseases, Dermatology, Otolaryngology, Urology, and General Surgery.
The Hefner VAMC has an active research and development program, including studies in biomedical research,
health services, clinical and cooperative studies, and rehabilitation. Research projects are currently being
conducted at Hefner in blast-related brain injury in veterans, post-deployment mental health, post-traumatic
stress disorder and traumatic brain injuries, prostate cancer, low vision, hepatitis C, vascular cognitive
impairment, and sleep disorders.
WF and the VAMC has established physician residency training program rotations in 20 specialties with
funding of 57.9 Wake Forest resident slots, and provides rotations for both medical and PA students.
Additionally, 7 WF-affiliated rural health training programs are in place to assure that the next generation of
health care providers learn about provision of rural health care and provide opportunities for rural health
careers. The Hefner VAMC’s PA residency program in primary care uses the VA’s medical home model of
primary care delivery. There are shared clinical faculty in many departments – with VA providing additional
funding for 11.4 faculty with 40% protected academic time. The VAMC is the primary education hub and
secondary research hub for the VISN 6 Mental Illness Research Education and Clinical Center (MIRECC) (i.e.
VA translational medicine center grant) with a focus on post deployment mental health (i.e. post-traumatic
stress disorder and traumatic brain injury). There are only 10 MIRECCs in the nation with an MIRECC
Fellowship Site: a program combining resources sponsored by the MIRECC, VAMC, and WF for education of
the next generation of clinician-researchers (PhDs and MDs). MIRECC Fellows can complete a Master’s in
Clinical and Population Translational Science (CPTS) at Wake Forest during fellowship, if desired. Additionally,
the VAMC has provided volunteer VA appointments to WF staff and scientists to support joint clinical studies.
Thus, the VAMC is an active partner with the TSI, interacting in multiple ways to improve veterans’ health.
G.7. University of North Carolina at Charlotte (UNCC)
UNCC is North Carolina’s urban research university, leveraging its location in the state’s largest city to offer
internationally competitive programs of research and creative activity, exemplary undergraduate, graduate, and
professional programs, and a focused set of community engagement initiatives. UNCC maintains a particular
commitment to addressing the cultural, economic, educational, environmental, health, and social needs of the
greater Charlotte region. Founded in 1946, UNCC has 92 bachelor’s, 59 master’s, and 19 doctoral degree
programs, with over 20,000 undergraduate students and 5,000 graduate students.
Dr. Yaorong Ge (Biomedical Informatics Program) is based at the College of Computing and Informatics (CCI)
at UNCC, one of the largest and fastest-growing computing and informatics programs in nation. Students are
exposed to a wide range of core and contemporary topics: computing systems and development, computer
gaming, information and cyber security, financial informatics, health information technology, and bioinformatics
and genomics.
G.8. Northwest Area Health Education Center (AHEC)
The AHEC Program began in 1972 with federal funding and is administered by the University of North Carolina
at Chapel Hill School of Medicine. In 1974, with funding from the NC General Assembly, it became a statewide
program. Today, there are nine regional AHECs statewide, supported primarily by state and local funds. The
Northwest AHEC (Dr. Michael Lischke, Director) forms a unique partnership between the region’s medical
centers and local communities. The program's goal is to meet the primary health care needs of the state by
improving the supply, distribution and quality of health care professionals. The Northwest AHEC encompasses
17 counties in northwest North Carolina. Two sub-regional bases, at Watauga Medical Center (part of the
Appalachian Regional Healthcare System) in Boone and Catawba Valley Medical Center in Hickory house
library collections, and staff and classroom space for continuing education and other activities.
AHEC has five key service areas: Health Careers - Diversity and Recruitment, Health Sciences Student
Support, Graduate Medical Education and Patient Services, Support for Practicing Health Professionals
through Continuing Education Activities and Services and Practice Support Services, and Information & Library
Research Services. The AHEC Digital Library includes full-text journals and textbooks, health care related
databases, evidence-based medicine resources, and other healthcare links. Online tutorials for successfully
using resources on the AHEC Digital Library are also available. Northwest AHEC offers a variety of live events
(traditional classroom, videoconferencing) and online courses. More than 150 courses are offered online,
including Internal Medicine Grand Rounds topics. With an annual budget of more than $5.6 million, Northwest
AHEC provided 1,883 continuing education activities to 12,793 unique individuals across different healthcare
professions in 2013/2014.
H. Resources Relevant To WF CTSA Areas Of Strength
H.1. TSI Clinical Research Unit (Director, Sarah L. Berga, MD)
The TSI’s Clinical Research Unit (CRU) is the home of the University’s clinical research unit (formerly the
General Clinical Research Center). The CRU provides investigators with the fundamental resources and
controlled environment necessary to conduct research with human subjects, and to help investigators translate
basic scientific knowledge into new or improved methods of patient care. It is the CRU’s policy to prioritize
resources for TSI-sponsored pilot studies and early-career investigators. CRU resources include expert
nursing, dietary, and laboratory personnel trained in research techniques. A total of 6,522 sq. ft. of outpatient
research space with nine examining rooms, each containing a bed/stretcher or exam table and the necessary
patient-care equipment; a procedure room with a power procedure table and surgical light with capabilities for
cardiac, respiratory, blood pressure, and pulse oximetry monitoring; a metabolic kitchen with the necessary
equipment to prepare special meals for studies with feeding components, and a CLIA-certified processing core,
with state-of-the-art equipment and freezer capacity for tracking samples through FreezerWorks ®. The space
was renovated in 2014 to improve efficiencies and facilitate use by research participants.
WF also instituted the first Geriatric CRU satellite in the nation within its Sticht Center on Aging. The Geriatric
CRU, adjacent to the Geriatric Research Center, is a 2,114 sq. ft. outpatient unit with 5 examining rooms, each
containing a bed or exam table and necessary patient-care equipment; a consult room for participant meetings;
a participant dining room, providing meals and snacks prepared in the metabolic kitchen; and a processing
laboratory for samples collected.
In the last five years, the CRU has seen over 39,000 visits for 176 studies with 83 different Principal
Investigators from 34 divisions/departments. These visits included 11,820 participants with the following
characteristics: 5,193 men and 6,627 women; 7,709 white and 4,111 minorities; 351 < 21 years, 6,117
between 22-65 years, and 5,352 > 65 years.
The Clinical Trials Office (CTO) facilitates the conduct of clinical trials across WF. It provides a centralized
infrastructure to enhance patient safety, promote quality research, ensure fiscal and regulatory compliance,
encourage collaborations, and ultimately increase the volume of clinical trials for the benefit WF’s patients. Led
by Abbie Eaton, PhD, the CTO supports 5 administrative staff to focus on review, initiation, and compliance
with six staff dedicated to providing a central pool of study coordinators available to assist investigators with
protocol implementation, conduct, and close-out.
H.2. Department of Emergency Medicine and the Emergency Medicine Network
The Department of Emergency Medicine (Chair, Dr. James W. Hoekstra) was originally established as a
Section in 1972 and currently consists of 144 faculty members. Faculty members staff 11 emergency
departments in the Piedmont Triad of North Carolina involving over 350,000 ED encounters annually. Dr.
Chadwick Miller (Core Faculty Member, KL2 Program) is the Executive Vice Chair of the Department. The
Emergency Department (ED) at WFBH’s main campus consists of 71 beds, with specialized patient care areas
within the ED including acute care, pediatrics and fast track. Also within the ED facility is a 16-bed observation
unit. The ED volume for 2014 is projected at 108,000 patient encounters. The research personnel currently
recruit from all areas of the ED for research studies.
H.3. Emergency Medicine Research Unit
The Emergency Medicine Research Unit (directed by Dr. Chadwick Miller) has extensive experience
conducting and enrolling patients in clinical trials. The research unit consists of experienced, full-time study
coordinators and staff who screen patients for research studies, primarily from the ED setting. Typical
screening for clinical trials occurs 6 days a week, allowing enrollment coverage 80 hours / week. Emergency
Medicine-specific Standard Operating Procedures have been developed and implemented, and team members
are trained to interact with and consent potentially vulnerable subjects. Personnel also are trained on rigorous
data quality management procedures and in conducting trials in accordance with Good Clinical Practice
standards. Regular team meetings track progress and ensure adherence. The Emergency Medicine Research
Unit has workspace in the Department of Emergency Medicine; existing equipment includes a centrifuge and 80˚C freezer for blood specimen and biomarker studies. This Unit, with consistent enrollment of patients with
acute illnesses or injuries, allows the construction of repositories involving time-sensitive disease processes.
H.4. Investigational Drug Service
The Wake Forest Investigational Drug Service (IDS) provides oversight and direction regarding all
investigational and study medications used in the conduct of human research as part of Wake Forest Baptist
Health. The IDS employs two pharmacists with Doctorate of Pharmacy degrees (Sara Moore, PharmD and
Brian Strittmatter, PharmD) who are responsible for supporting research efforts throughout the institution. Dr.
Strittmatter also has a Master of Science in Clinical Research. The IDS is involved in all phases of the protocol
life cycle. Core pharmacy services include: 1) Study initiation activities (e.g. attending site initiation visits and
study team meetings before study start-up); 2) Supporting the building of WakeOne treatment plans into the
EHR (WakeOne system),as required; 3) Study-related activities (e.g. coordinating the ordering and resupply of
investigational products, dispensing all investigational products, and ensuring appropriate storage and disposal
of all investigational products); 4) Study inventory activities (e.g. maintaining accurate inventories of all
investigational products, including expiration dates); 5) Providing drug information about investigational
products; 6) Training other pharmacy staff as needed to ensure reliable pharmacy service; 7) storing returned
products in accordance with study regulations and WF policies; and 8) Study closeout activities (e.g.
coordinating appropriate disposal of investigational products, storing all study-related materials indefinitely or
until destruction is authorized). The IDS has a smooth working relationship with the CRU, and can be a
particularly valuable resource for TSI-supported pilot studies or support of early-stage investigators.
H.5. TSI Program in Community Engagement (PCE)
The PCE (Director, Thomas Arcury, PhD) employs a conceptually-based process of community engagement
designed to increase the pace of laboratory and clinical science translation to improve population health, health
practice, and policy. The PCE has established a collaborative leadership and stakeholder organizations,
executed a process of bi-directional communication, and implemented a set of program services. The PCE
leadership is provided by academic and community investigators and two Community Research Advocates
who are members of community-based organizations. These individuals have a status equal to that of a coinvestigator, and the PCE pays for their effort.
The Core Working Group (see Table 3) serves as an
executive committee for the PCE that develops and
implements programs to support community-engaged
health programs. Each group member is assigned to a
committee or task to maximize use of members’ expertise
most efficiently.
A Stakeholder Advisory Committee (see Table 4 for
members) is the connection between the community and
the TSI. Subcommittees of the Stakeholder Advisory
Committee work with the academic and community
investigators to accomplish specific tasks, such as
selecting topics for the Skill Development Workshops. The entire Stakeholder Advisory Committee meets
quarterly, although subcommittees meet with greater frequency.
I. Institutionally Recognized Centers and Cores
WF has established 8 institutionally supported research centers. There are also 4 core areas, each with a set
of centralized scientific technical services. Institutional support for centers and cores is prioritized based on
review of proposals by an intramural peer-review committee. Centers are provisionally funded for 3 years,
based on annual reviews of progress by the Dean of the Medical School and the Associate Dean for
Interdisciplinary Research (Dr. Lynne Wagenknecht, Associate Director of the Implementation and
Participation Program). Cores are reviewed annually by a similar process. These entities collectively contribute
to the translational research mission of WF. Each is briefly described below.
I.1. Institutionally Recognized Centers
Center for Comparative Medicine Research (Director, Dr. Jay Kaplan): Home for infrastructure and expertise
in support of all investigators using animal models to study diseases of human relevance. Use of nonhuman
primates as models for diseases of public health significance is a notable area of expertise (see Section 6.3.).
Center for Genomics and Personalized Medicine Research (Co-Directors, Drs. Eugene Bleecker and
Deborah Meyers): Committed to translational research in the genetics and genomics of disease susceptibility,
severity, and progression, and in response to treatment for multiple common diseases. Asthma and diabetes
are particular strengths.
Center for Public Health Genomics (Director, Dr. Carl Langefeld): Encourages and facilitates research
related to the genomics of diseases of public health impact, through shared ideas, interdepartmental
collaborations, and development of shared analytic tools and analysis pipelines. Areas of focus include the
institutionally strategic areas of aging/cognition, diabetes, obesity, cancer, and regenerative medicine.
Comprehensive Cancer Center of Wake Forest University (Director, Dr. Boris Pasche): Focuses basic,
clinical, and population sciences expertise on problems in cancer prevention, early diagnosis, novel treatment,
and survivorship research.
Critical Illness, Injury and Recovery Center (Director, Dr. Peter Morris): Seeks to improve the burden of
critical care-related disorders on human health. Approaches span prevention and treatment and use a
discovery-based model to bridge the translational spectrum of research across basic, clinical, epidemiologic,
and health policy sciences.
Hypertension and Vascular Research Center (Director, Dr. Debra Diz): Effectively facilitates research,
education, and clinical management of hypertension and vascular disease. The Center generates visibility for
investigations into hypertension specifically and cardiovascular disease in general, and creates a nexus of
activities to foster innovation and new discoveries in this field.
J. Paul Sticht Center on Aging (Director, Dr. Stephen Kritchevsky): Promotes the health and independence
of older adults by fostering multidisciplinary collaboration in basic and clinical research, research training,
professional education, and community outreach. The Center’s guiding philosophy unites scientists and
practitioners from multiple specialties to address two critical problems that rob older adults of their
independence – mobility disability and dementia.
Maya Angelou Center for Health Equity (Director, Dr. Ronny Bell): Works toward health equity by
transforming scientific discovery to action. Its three programs support its mission to conduct translational
research that will impact population health, develop sustainable and mutually beneficial community
partnerships, and deliver educational initiatives to diversify the clinical, biomedical, and public health workforce.
I.2. Research Core Facilities and Shared Equipment Services
By sharing resources, researchers at Wake Forest access equipment, laboratories, and expertise that might be
unattainable individually. While some resources are available to outside researchers, others are not. Each
resource offers expertise unique to each specialty.
Animal Models: includes comparative pathology, diet preparation laboratory, dual X-ray absorptiometry
imaging suite, mobile imaging platform, and a nonhuman primate nursery suite (see Section 6.C).
Biochemistry and Structural Biology: includes analytical ultracentrifugation facility, bioanalytical nuclear
magnetic resonance laboratory (instrument), biomolecular computing and graphics, macromolecular
interactions core laboratory, mass spectrometer facility, protein analysis core laboratory, and crystallography
and computational biosciences.
Bioenergetics Core Laboratory: includes Seahorse equipment and expertise to conduct mitochondrial
experiments.
Cancer: analytical imaging core laboratory, bioanalytical laboratory, biostatistics core (in the Comprehensive
Cancer Center), cell and viral vector core laboratory (in the Comprehensive Cancer Center), cellular imaging
core, flow cytometry laboratory, mass spectrometer facility, cancer genomics (microarray), tumor tissue core
laboratory (in the Comprehensive Cancer Center), and
crystallography and computational biosciences.
Hypertension and Lipid Sciences: hypertension core
laboratory, hypertension core radioimmunoassay facility,
molecular and cellular biology research facility, peptide
biochemistry and metabolism research laboratory, transgenic
animals and instrumentation facility, and preclinical ultrasound
and imaging core (Vevo LAZR instrument).
I.3. Other Research Centers
Selected institutional centers related to specific research or
clinical areas of expertise are listed in Table 5. Some are
supported by primarily by federal grants (e.g. the Center for
Neurobiology of Addiction Treatment, Translational Center for
Neurobehavioral Study of Alcohol, Wake Forest and Harvard
Botanicals Center). The Clinical Centers are primarily focused on
patient care, but serve as an important venue for recruitment of
patients into relevant clinical trials (e.g. the Heart Center and the
Stroke Center).
J. Educational Resources
Two graduate-degree programs of relevance to the TSI are the Clinical and Population Translational Science
program (CPTS) (MS degrees), and the Molecular Medicine and Translational Science (MMTS) program (MS
and PhD degrees).
WF established the MS in Epidemiology in 1988 and, in 1997, added the MS in Health Services Research,
merging these programs in 2000 into Clinical Epidemiology and Health Services Research. In 2008, the
program was transformed into the current CPTS program, administered through the Division of Public Health
Sciences and the TSI. CPTS provides students will the skills necessary to translate laboratory discoveries to
human populations and to conduct research aimed at enhancing the adoption of best practices in healthcare
settings and the community. It is open to individuals who already hold or are pursuing advanced degrees, such
as the MD, DVM, ScD, PhD, DDS, DSN, MMS (Physician Assistants), or MSN who seek training in the clinical
and population aspects of translational research. The program may be appropriate for qualified applicants with
at least a BA or BS in a social science, public health, or other health-related field, although post-baccalaureate
coursework may be required. The Co-Directors of the program are Drs. Robert Byington and Kathryn Weaver
(see Letter of Support).
In 1997, WF established the interdisciplinary Molecular Medicine program, offering the PhD to BS, MS, and
MD students and the MS to WF clinical faculty. It was one of the first Molecular Medicine PhD programs to
integrate clinical experiences. With the launch of the TSI in 2007, the degree program’s name was changed to
MMTS, to reflect the focus on training translational scientists in the molecular principles of human health and
disease. This interdisciplinary program offers students knowledge of human biology and disease that allows
them to develop basic research programs with fundamental clinical implications. The multi-disciplinary faculty
members have major ongoing human research programs. An additional benefit of the program is enhanced
interaction between MDs in clinical departments and PhDs engaged in bench research. Training is provided by
physicians and basic scientists from Biochemistry, Cancer Biology, Genomics, Internal Medicine, Microbiology
and Immunology, Neurobiology and Anatomy, Physiology/Pharmacology, and Regenerative Medicine. Dual
mentorship (MD and PhD) is a key component. The program is led by Drs. Bridget Brosnihan and John Parks
(see Letter of Support).
The core curricula for the CPTS and MMTS programs are shown in Table 6 below.
J.1. Wake Forest Graduate School of Arts & Sciences
The Wake Forest University Graduate School of Arts and Sciences offers 28 disciplinary or
interdisciplinary programs and sponsors 8 programs jointly with the Schools of Medicine (MD/PhD &
MMS/PhD), Business (MBA/PhD) and Divinity (MA/MDiv). A total of 755 students are enrolled in graduate
studies. On the Bowman Gray (biomedical campus), the School is led by Dr. Dwayne Godwin, Dean for the
Graduate Program in Biomedical Sciences. A course in the Responsible Conduct of Research is required for
each student (either CPTS 703,704 or GRAD 713,714, depending on the student’s concentration). The
Graduate School is also a portal to non-credit courses, workshops, seminars, and services offered across the
University, such as those at the Professional Development Center. During the academic year 2010-2011, the
Graduate School of Arts and Sciences streamlined its Ph.D. programs
into 7 tracks (see Table 7), each of which has a common recruiting
process and core curriculum. The first-year curriculum is unique to
each track, allowing students to opt into one of numerous programs
and laboratories available to that track. Students rotate through
laboratories before selecting their thesis topic, committee, and home
laboratories for their thesis work. The new tracks have greatly simplify
the application process, improved curricular coherence, facilitated
recruiting, and encouraged the participation of faculty in the Graduate
School programs.
In fall 2015, a new MS program in Health Disparities in Neuroscience-related Disorders will be offered. In the
past, basic, clinical, and community-based researchers operated in separate domains, often creating barriers
to the translation of scientific findings into widespread improvements in human health. While the CPTS
program was developed to begin to address this translational gap, at the same time, the Graduate Program in
Neuroscience committed to providing training in translational research by developing a clinical neuroscience
course that engaged basic scientists and clinicians to address neurological disorders and to identify potential
therapeutic interventions. These programs joined forces with the NIH P60-funded Maya Angelou Center for
Health Equity to create this new degree program. Drs. Ronny Bell and Carolanne Milligan are the Co-Directors,
and the program’s initiation is supported by their joint NIH grant (R25 NS089458, “Training in Health Disparity
Research for a Diverse Neuroscience Workforce”).
J.2. The Physician Assistant Program (Chair, Reamer Bushardt, PharmD, PA-C)
The Physician Assistant (PA) Program at WF, begun in 1969, is a graduate-level program with a unique history
of curricular innovation using clinical problem-based learning strategies that emphasize a small-group
approach to learning. Graduates of the PA Program complete a 24-month course of study and are awarded the
Master of Medical Science (MMS) degree. One class of 64 students is enrolled in early June each year. Both
the academic Department of Physician Assistant Studies and the educational program are led by Dr. Bushardt.
In 2011, he spearheaded the formation of a collaboration with the new College of Health Sciences at
Appalachian State University in Boone, NC (described in section G.3. above). The vision of this collaboration is
to improve health care in the rural areas of western North Carolina.
Each PA Masters candidate is to complete an Evidence-Based Medicine (EBM) Master Project prior to the end
of the Clinical Year that is an EBM review or scholarly activity approved by the program. Completion of the
Master Project is a graduation requirement. The final outcome of the Master Project will be a manuscript ready
for submission for publication in a peer-reviewed journal. This paper will be an EBM review or the outcome of a
project that is designed by the candidate. Candidates will present the completed project or project-to-date in
oral, poster or other suitable form in the community or at a professional meeting and/or on campus. Projects
must be designed to have a specific and measurable impact on PA education or on community health policy
and/or practice. The research must meet rigorous methodological standards and advance knowledge.
J.3. Translational Science Institute Research-Focused Training Opportunities
The Translational Science Institute, including the IRB, IACUC, Sponsored Programs, and the Clinical Trials
Office provide targeted training and professional development opportunities throughout WFBH and to TSI
affiliates for research faculty and staff. Over 50 courses are provided on a standing rotation and can be
customized for specific groups (i.e. departments, centers, or affiliate groups). The range of courses is
displayed in Table 8 on the next page.
J.3.1. The TSI Translational Research Academy. The TSI Translational Research Academy is a two-year
non-degree program, offers educational opportunities in the form of seminars and workshops, which address
both scientific issues and the process and conduct of research, all designed for clinical and translational
research trainees. Beginning in 2010, the Academy integrated the trainees of all institutional training grants,
allowing trainees across disciplines the opportunity to interact as a single networked collaborating cohort.
Members of the Academy also can pursue formal training in the degree programs described above.
J.3.2. Responsible Conduct of Research (RCR). TSI staff members provide multiple educational workshops
each month to the research community, most of which discuss ethical issues in the context of the specific
topics (e.g. grant applications, manuscript publication, animal welfare, and human subjects research). These
are listed on the TSI website and are free of charge. Specific offerings are listed below.
J.3.2.1. Introduction to the Responsible Conduct of Research. To address RCR training requirements for
NSF, NIH, and other sponsors, it is strongly recommended that all postdoctoral fellows attend this workshop. In
addition, faculty and faculty mentors, students, research staff, lab techs and other individuals involved in
research activities, including training grants, are also encouraged to attend. This workshop provides an
overview of the nine standards for the responsible conduct of research, which include: Protection of Human
Subjects, Welfare of Laboratory Animals, Research Misconduct, Conflicts of Interest, Mentor and Trainee
Responsibilities, Data Management Practices, Collaborative Research, Peer Review, and Authorship and
Publications. In addition to a basic introduction of the foundations, core principles, regulations, institutional
systems and current issues concerning RCR, case studies are presented and discussed. All cases reinforce
the workshop content and provide attendees with an opportunity to participate in discussion of the cases.
Participants receive a list of valuable resources and supplemental reading related to the 9 core areas of RCR,
as well as an RCR Basics Certificate indicating completion of the course. This course fulfills the following RCR
requirements: 3 credit hours.
J.3.2.2. Sticky Situations in Publishing. A panel of experts will lead discussions of case studies covering
commonly encountered – and tricky – situations related to RCR in manuscript preparation and publishing.
Panelists will share their insights and experiences as mentors, administrators, co-investigators and coauthors.
To address RCR training requirements for NSF, NIH, and other sponsors, it is strongly recommended that all
postdoctoral fellows attend this workshop. Graduate students, faculty members and research associates are
also encouraged to attend. This course fulfills the following RCR requirements: 2 credit hours
J.3.2.3. Human Research 101 (Parts I & II). This is a two-part hands-on workshop designed to cover IRB
policies and procedures, federal regulations, Good Clinical Practice guidelines, and HIPAA rules and
regulations. Participants will also be able to identify the essential documents of a regulatory binder, create
source documents and a subject binder, develop a consent form and other essential tools needed to be a
successful research-team member. This course fulfills the following RCR requirements: 2 credit hours per part.
Designed for WF Graduate Students; open to fellows, faculty and staff
 Scientific Professionalism: Scientific Integrity (GRAD 713; 1 semester) – focuses on norms and roles
within the culture of science. Content includes the norms and principles for the responsible conduct of


science such as data acquisition, management, sharing and ownership, publication practices, and
responsible authorship.
Scientific Professionalism: Bioethics and Social Responsibility (GRAD 714; 1 semester) – focuses on
the interaction of science and the scientific community with society. Content includes the entrance of
bias into research, limits of scientific authority, conflicts of interest, peer review, human and animal
subjects, commercialization and globalization of science, scientific freedom and responsibility, and right
of conscience.
Ethics and Responsibility in Clinical and Population Science I, II (CPTS 703, 704; 2 semesters).
Content includes RCR norms and principles related to data acquisition, management, sharing and
ownership, publication practices, and responsible authorship.
J.3.2.4. Human Subjects Research. A course that includes additional instruction for fellows, faculty or staff
who conduct human subjects research per federal regulations including CITI training and ethical issues (e.g.
confidentiality, vulnerable subjects). The course includes graded posttests requiring a minimum score to
receive a certificate. Training must be renewed via a refresher course every three years. The IRB requires
proof of CITI training for all study team members before initial approval of research, and at continuing review.
J.3.2.5. Animal Subjects Research. Certification in animal subjects research is offered online via the
American Association for Laboratory Animal Science (AALAS) learning library, which can be accessed through
the eIACUC site. The Institutional Animal Care and Use Committee (IACUC) monitors completion of training
modules; protocols are not approved unless all research personnel have completed the appropriate modules.
The Principal Investigator for the project must ensure that an individual is in the eIACUC system before that
person can access the training modules. All new research personnel who are involved with the use of animals
in research must complete the four base modules of the AALAS learning library.
J.3.2.6. Ethics: Other Graduate School courses relevant to the ethical conduct of research currently include:
1) Biomedical Research Ethics (BIE 702); Clinical Ethics (BIE 705);and Ethics of Health Communication (BIE
709). The current RCR curriculum for biomedical graduate students at the WF Medical Center Campus is fully
automated via a curriculum management system called eWake, developed and managed in house by the
Office of Academic Computing. Course and background reference materials are available to facilitators and
students; cases can be presented directly to small groups via the web, and grading is completed online.
J.4. Short Courses
The TSI offers short courses (Table 9) to address identified learning needs for clinical and translational
research, particularly for early-career researchers.
J.5. Ready-When-You-Are Online Courses
Ready-When-You-Are courses are digital video recordings of faculty/staff presentations along with PowerPoint
slides, available on a 24-hour basis and with free access. A simple registration process captures information
about users and an evaluation questionnaire determines the value of the course to the learner. Courses are
designed to provide faculty, staff and students an opportunity to learn about the research process without
having to adhere to standard course times. Although continuing education credits are not provided, learners
can cite them as self-directed learning activities. New courses are added periodically and courses are removed
as needed. A list of current offerings include:
Academic Writing in a High-Stakes Context: In a high-stakes academic environment, both professors and
students need to write well and often, yet many struggle to finish stalled dissertations, journal articles, book
chapters, or grant proposals. Writing can be difficult to incorporate into a demanding academic schedule. In
this session, senior faculty share practical tactics and actions to help investigators overcome motivational
roadblocks and become a more productive academic writer.
Comparative Effectiveness Research: Why, What, and How?: This course provides an overview of
comparative effectiveness research (CER). CER is designed to inform healthcare decisions by providing
evidence on the effectiveness, benefits, and harms of different treatment options including drugs, medical
devices, tests, surgeries, or ways to deliver health care. It is an important component of translating research
into a form that is quickly usable by clinicians, patients, policymakers, and health plans and other payers.
Getting Started in Research: Finding the Research Question: Good research starts with good questions.
This session, is geared towards emerging independent investigators and addresses what makes a good
research question, how to develop a question from an idea, and how simple questions can lead to important
answers.
Getting Started in Research: Working with Your Statistician: Statistical support is an important
consideration to make early in the development of a grant application. This course covers the role statistics
play and working with a statistician to provide guidance about statistical methods for data analysis. The
statistician can provide crucial input about study design, sample size, randomization, and other fundamental
research decisions. Faculty members discuss how statisticians can assist throughout the research process
and ways to prepare for a statistical consultation.
IND Holder Responsibilities: Special Requirements for Those Who Hold an IND (I & II): This course
covers the basics of applying for an IND, and what is involved in holding an IND. Institutional experts share
their experiences with the process and address specific requirements for INDs held at WFBH. The
presentation is targeted towards human subjects researchers who want to gain knowledge about FDA
regulations and requirements for obtaining and holding an IND and the responsibilities that IND holders have
with respect to reporting and clinical trial oversight.
An Introduction to Health Services Research - Overview of the Health Care System and the Role of
Health Services Research in Translation: This course is an overview of the health care system and the role
of health services research in translation, discussing the entities and organizations that play a role in how
research dollars are distributed and how the translation of research is impacted.
Network Science and Its Application to Collaborative Research: The impact of social networking and the
networking model has been applied to research networks through faculty publications and areas of research
interest. This course discusses network science and how it can be applied to evaluating the strength of
collaborative research in an academic institution.
The Nitty Gritty of NIH Grants: This workshop is geared toward less experienced grant writers, as well as
people who want to learn more about the whole grant submission process. The goal is to make the grant
application experience less harried and more likely to succeed. Because of their importance and complexity,
the focus will be on NIH-style applications. We will cover insider tips – “tricks of the trade” – that can make all
the difference in today’s highly competitive grants environment. Discussion of the review process at NIH is
included.
Pilot Study Applications –Tips for Success: This session, provided by senior faculty with long histories of
funding success, covers the functions and characteristics of pilot studies as well as commentary on the
process of how studies are reviewed. The workshop offers practical advice on how to write a successful pilot
study application.
Translating Research into Community Action: Pesticide Research with Farmworkers: Based on over
ten years of work by a multi-disciplinary team of investigators with farmworker community organizations, this
presentation will trace the pathway from conducting survey and biomarker research to translation.
Revise and Resubmit - Responding to Manuscript Critiques: Karen Klein (TSI’s Director of Grant
Development and Medical Editing) is a board-certified medical editor who has worked at three different
medical journals. She discusses how to handle a manuscript that has been returned with a request for
revision. The focus is on how to revise the manuscript to be responsive to the critiques, and ways to handle
the resubmission process.
Secondary Data Analysis for Health Services Research: This course is provided by faculty within the
Division of Public Health Sciences. The course describes how to identify sources of data that are available for
secondary data analysis, and the advantages and disadvantages of using these data for health services
research.
Translational Research - Patient to Bench and Back Again: Dr. John McConnell, CEO of Wake Forest
Baptist Medical Center, presents a case study of many years of his own translational science research in the
field of urology. Dr. McConnell describes the iterative process of taking a challenging clinical question,
improving the understanding of the problem through basic research, and transferring that knowledge back to
improved clinical care and outcomes.
What PCORI Wants – Tips From an Insider: PCORI (Patient-Centered Outcomes Research Institute) is a
grant-giving agency funded through the Affordable Health Care Act. How are they different from NIH or other
funders, and what are they looking to fund? Karen Klein, a member of PCORI’s Communication and
Dissemination Research study section, will share tips on what PCORI is looking for, and how (and how not) to
design projects that fit their mission.
Writing Scientific Results and Conclusions: Writing scientific material articulately and with specific
audiences (i.e. publishers and funding agencies) can be challenging, particularly with a demanding academic
career. This course addresses how to present scientific methods and the results and conclusions of
experiments in manuscripts and grant applications.
Writing Scientific Introductions: Brevity and clarity are critical components of scientific writing particularly
related to changes within the national funding framework (NIH, NSF, etc.) to short grant applications by
reducing page limitations. This course uses the principle of "the shortest logical path" in writing introductions
to grant applications and manuscripts.
Writing for Clarity: Articulating complex scientific concepts and models in a clear concise manner while
maintaining an interesting narrative is a key component to “capturing” reviewer’s attention and delivering aims
and methods in apparent terms is critical in a competitive academic environment. This course delivers three
basic techniques for improving the clarity of scientific writing.