Vanderbilt Institute for Clinical and Translational Research
Clinical Research Center
The Clinical Research Center (CRC) is a central, physical research hub within the Vanderbilt Institute for
Clinical and Translational Research, providing a full service clinical research center that is open 24 hours per
day, 7 days per week. Current facilities include 14 inpatient licensed hospital beds and an additional 3 hospital
beds. All 17 are used for both inpatient and outpatient research visits. We have 6 general outpatient research
exam and procedure rooms, a metabolic kitchen, a CAP/CLIA certified laboratory, and other specialized core
labs. The CRC infrastructure and resources provide support to investigators for the efficient conduct of
investigations of compelling quality, most of which would not have been possible otherwise. The CRC
encompasses closely integrated adult and pediatric inpatient and outpatient facilities, with 23 full time nurses
and 14 technical support staff.
These
resources
have
supported 518 new studies over
the past 3 years, involving both
adult and pediatric participants,
Hematology/Oncology
Allergy/Pulmonary
conducted by approximately 233
Clinical Pharmacology
investigators. These users come
Infectious Disease
from the Vanderbilt Medical
Pediatric Psychiatry
School, School of Nursing,
Cardiovascular Medicine
Peabody School of Education
Pediatric Hematology
Pediatric Genetics
and
Human
Development,
Pediatric Endocrinology
School of Engineering, the
Psychiatry - Adult
Lipscomb School of Pharmacy,
Pediatric Neurology
and the Meharry Medical and
Pediatric Infectious Disease
Nephrology
Dental Colleges. In fact, since
Pediatric Pulmonary
1994, we have hosted all
Pediatric Nephrology
inpatient
investigator-initiated
Pediatric Cardiology
clinical research protocols from
Neuromuscular Div
Meharry, and many outpatient/
General Surgery
VU/Meharry Ctr in Sickle Cell
community
protocols
from
Vanderbilt Kennedy Center
Meharry investigators. The CRC
Psychology
is highly productive, initiating
Pediatric Gastroenterology
approximately
170
new
Pediatric Clinical Research
Pathology,Microbiology,Immun
protocols each year.
Each
Otolaryngology
protocol is executed, managed,
Ortho-Sports Medicine
and overseen by a trained team
Neuro-Movement Dis Div
of
investigators and care
Neurology Pediatric Division
providers.
These
include
Neuro-Cognitive Dis Div
Neonatology
protocols which are resource
Rheumatology
intensive and of high acuity,
Radiology
such as investigations requiring
Liver Transplant
glucose clamp or insulin clamp,
Internal Medicine
studies
of
hypertension
GI Medicine
Diabetes/Endocrinology
mechanisms with intravenous
ganglionic blocking agents, or
0
2
4
6
8
10
12
14
intensive Phase I studies of
pharmacodynamics
with and
Figure 1- Divisions supported by CRC 2013
without
controlled
diet
interactions. All investigators have access to these resources on a competitive basis, with rolling submissions.
Studies are led by expert teams in a dedicated, sophisticated facility designed with the capability to support a
broad spectrum of investigation. The presence at Vanderbilt of one of the nation's largest and most active
Clinical Pharmacology divisions ensures a vibrant portfolio of advanced, mechanistic patient-oriented
research and a full range of drug studies encompassing every stage of the process of drug development from
CRC Supported Division
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new target identification to compound discovery through Phase 1 studies, and beyond. PK/PD studies which
require very precise timing of drug administration, blood draws and processing, and constant monitoring for
the highest standard of safety, are a particular strength.
CRC OPERATIONS
The CRC is broadly utilized, and available to all. It has been utilized by investigators from 36 divisions (Figure
1). To ensure that all studies utilizing CRC resources meet the highest standards for quality, science, and
safety, a Scientific Review Committee (SRC) evaluates the quality of science, feasibility of the study design
and statistical plan, data and safety monitoring plans, and prioritizes requests for support. This committee is
an independent review body responsible for allocation of all pilot and research funding and other resources of
VICTR. The centrality of prioritization by one robust SRC with experienced investigators drawn from many
disciplines, with a common mandate for rigorous scientific evaluation, ensures equivalent treatment of all
proposals.
CLINICAL AND TRANSLATIONAL RESEARCH RESOURCES
Facilities
The Clinical Research Center (CTRC) consists of the Clinical Research Center (CRC), the Pediatric Clinical
Research Center (Pedi CRC) and the Clinical Trials Center (CTC). While building upon successes, the CRC
represents both an expansion and an evolution of the GCRC antecedent in providing an environment that
promotes participation in and facilitates clinical and translational research by serving as the anchor of the
translational research program at Vanderbilt. To this end, the CRC not only encompasses the physical space,
personnel, equipment, facilities, and core facilities within Vanderbilt but also proactively reaches beyond the
institution to support community research. It seeks to provide resources where the scientific effort to
understand health and disease converges with direct participant contact. The current CRC facilities include 17
hospital beds used for either inpatient or outpatient research visits, six general outpatient research exam and
procedure rooms, two outpatient exam and treatment rooms with office space dedicated to HIV research, a
metabolic kitchen and participant dining facility, conference rooms, fully equipped specimen processing and
storage facilities (Table 1 ), and core laboratory space, listed in (Table 2).
CTRC Nursing, Space and Facilities Summary
Inpatient CRC
15 inpatient nurses; 17
inpatient rooms; 1 whole
room calorimeter; 2 sleep
research rooms; energy
balance core; cardiovascular
core; bio-nutrition core;
shared specimen suites
Outpatient CRC
Outpatient CTC
Outpatient Pedi CRC
8 outpatient nurses; 6
10 research nurses; 2
8 shared outpatient nurses; 3
outpatient exam rooms; 2
outpatient exam rooms; 5
outpatient exam rooms; 2
large procedure rooms; 2
research coordinator offices; infusion rooms; 1
HIV/AIDS focused rooms; 1 1 specimen processing
neurocognitive testing room;
infusion room; 2 specimen
suite; 2 sponsor monitoring 1 specimen processing,
suites for processing,
visit rooms
storage and shipping suite; 2
storage and shipping
researcher workspace
(freezers, refrigerators,
rooms; access to Children’s
centrifuges, bar-coded
Hospital scatter beds
sample IDs
Table 1: The CTRC provides investigators with a variety of research space and facilities in multiple locations.
Altogether, the CTRC facilities (main center and ancillary areas) constitute just over 18,000 square feet of
dedicated space in Medical Center North, The Doctors Office Tower of the Monroe Carell Children’s Hospital
and the Village at Vanderbilt. This space is further complemented by strategic inpatient and outpatient
satellites within Vanderbilt Children’s Hospital to accommodate pediatric research (1940 square feet), and a
satellite in the new Vanderbilt Imaging Center provides another 500 net square footage dedicated to clinical
research in addition to the space required for the imaging equipment and imaging support areas.
Pediatric CRC: The pediatric CRC research located at Vanderbilt Children’s Hospital includes five outpatient
exam and treatment rooms designed specifically for pediatric research, a specimen processing and storage
facility, pediatric specialty equipment, and two-way observation mirrors and a conference room with tables
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and chairs for neurocognitive testing and parent interviews. Pediatric studies of unusual complexity requiring
inpatient monitoring are supported as off-site hospital beds in Children’s Hospital.
Clinical Trials Center (CTC): The CTC in the Village at Vanderbilt satellite location supports 60 active
protocols among 10 staff members including a clinical director and research staff. Investigators receiving
support from the CTC have research funding from industry, NIH, foundations, VICTR, and departmental
funds. This resource is a valuable asset for new investigators who need clinical research expertise to begin
their careers. The CTC provides a menu of services to support investigator-initiated research (such as shortterm regulatory support or full-service research protocol administration including budget administration,
recruitment operations and study visit support). The staff are available to travel into the community as their
support is awarded by the VICTR Scientific Review Committee. The CTC occupies 3000 square feet in the
Village (an on-campus facility) and has two dedicated research exam and treatment rooms, specimen
processing and storage facilities, two monitor visit rooms, a waiting area with a receptionist, office space for
administrative and nursing staff, and convenient parking for participants.
Nursing Resources
Experienced nurses form the human foundation of the CRC, with tenure ranging from one to 25 years. Led by
nurse manager Lana Howard, BSN, RN the Vanderbilt CRC nursing staff are all licensed RNs, and 50% have
critical care backgrounds, 10% hold national certification in oncology, 10% have advanced nursing degrees,
and 4 are enrolled in advanced studies. Ms. Howard manages a nursing staff of 23 nurses 15 of whom staff
the CRC’s inpatient program 24/7. Deloris Lee, BSN, RN, is the assistant nurse manager for the Pediatric
CRC. Ms. Howard and Ms. Lee supervise, direct, evaluate, and participate in daily unit operation. They
designate 50-80% of their time to providing expert clinical care. Other responsibilities of the nursing leadership
include staff development, mentoring investigator and research staff, protocol review, and committee
participation. CRC nurses maintain ACLS provider status. They complete an extensive orientation and training
program that includes instruction on human subject protection and good clinical practice and a mentored
clinical research training program with an emphasis on protocol adherence. Research nurses participate in
ongoing clinical research training that includes GCP and human subject protections with annual recertification
through the IRB. Nursing research participation by CRC nurses is exemplified by serving as co-investigators,
co-authors, and by active participation in research internship activities. CRC nurses are widely recognized
within the institution for their knowledge of clinical research and clinical expertise. The CRC support research
at the site of the need, wherever that may be. The CRC inpatient and outpatient service has enjoyed the
highest rank among all Vanderbilt Medical Center hospital units with 100% satisfaction scores. In addition, the
CRC patient satisfaction data, compiled by independent firm Professional Research Consultants, is
benchmarked against 243 medical centers nationwide, and our CRC is ranked in the top 1% for overall quality
of care.
CRC Core Resources
The CRC provides access to core laboratories critical to patient and clinical interactions that have both a
service and investigative arm.
CRC Cores Operating in CRC Space
Core
Key Equipment/ Resources
Metabolic Core
Bicycle Ergometers; Treadmills; Metabolic Carts; Activity Monitors; DXA Scanner;
Bioelectrical Impedance; BodPod; Metabolic Chamber; Pedometers
Assay Core
DNA extraction; Catecholamines; Cystatin C; IL-1RA; Melatonin; NT-pro BNP; Potassium
STAT; Pregnancy Test; 6- Sulfatoxymelatonin; Cortisol; NGAL; Nitrogen; Glucose analysis
Sleep Core
Two stationary sleep monitoring systems; Two ambulatory sleep monitoring systems;
Actigraphy; EEG
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Cardiovascular
Core
Dietary Core
Phase 1 Core
Autonomic Testing System; Vascular and Cerebral Doppler; Microneurography
Echocardiograph/Ultrasound/Vascular; Blood Flow Measurement Devices; Tilt Table
testing; Echo/vascular Sonographer
Metabolic Kitchen; Dieticians; Food Record analysis; ProNessy/NDSR Food Analysis; Diet
Instruction
Inpatient and outpatient space and expert nursing support; centrifuges,
freezers/refrigerators; specimen processing support and specimen tracking database;
investigational drug services; telemetry, ECG/ Blood pressure devices; drug infusion
pumps; emergency response carts; metabolic diets, Investigational Drug Pharmacy,
pharmacokinetic modeling
Table 2: The CRC cores located at the CRC provide yearly support to multiple research protocols.
MANAGEMENT AND ORGANIZATION
David Robertson, MD, leads the
CRC, assisted by two Associate
Program
Directors
and
an
Administrative
Director.
The
Associate Directors are active,
patient-oriented investigators central
to VICTR and drawn from the
disciplines of Pediatrics, and Clinical
Pharmacology. Each has a specific
responsibility in the organization of
inpatient services (Robertson), adult
outpatient services (Biaggioni), and
pediatric unit (DeBaun).
David Robertson, MD
CTRC Director
Todd Rice, MD
Director
Lynda Lane, MS
Research Subject Advocacy
Administrative
Director
Italo Biaggioni, MD
Associate Director
Adult CRC
Michael DeBaun,
MD
Associate Director
Pediatric CRC
Deloris Lee, BSN, RN
Lana Howard,
BSN, RN, CCRP
Assistant Nurse Manager
Nurse Manager
Pediatric CRC
22 Adult and
Pediatric
Integration of the CRC with the
Inpatient Vanderbilt Medical Center
Outpatient
CRC Management
Nurses
Our University Hospital is a tripletowered, 626 bed structure with
approximately 50,000 inpatient stays per year, and the region's only Level I Trauma Center and its only Burn
Center. Monroe Carell Jr. Children's Hospital at Vanderbilt is the most comprehensive children's hospital in
the state, providing the highest level of neonatal intensive care in Tennessee. The CRC holds 14 of the 628
licensed beds at VUH and has access to inpatient scatter beds at the Children’s Hospital. The VU hospital
and outpatient clinic is located directly between the adult CRC located in MCN, the Pediatric CRC located at
the Children’s Hospital and the Clinical Trials Center located at the Village at Vanderbilt . Our nursing staff are
credentialed through VUH as Vanderbilt registered nurses and follow the same policies and procedures as all
RN staff including annual training requirements through continuing education and ACLS credentialing. The
CRC occupies ~13,050 sq ft of hospital space within Medical Center North and ~2000 sq ft of outpatient
clinical space at Vanderbilt Children’s Hospital outpatient clinic. Vanderbilt Hospital provides a full-time
medical resident who rotates each month specifically on the CRC. This is based on our conviction that
exposure of third year residents with an aptitude for and a potential interest in clinical and translational
research with an outstanding educational experience is an optimal way to push them forward in their career
development. Many of our institution’s brightest young investigators have benefitted from this experience. The
CRC medical resident is available within the CRC for admitting history and physical exams, rounds on the
patients to provide care, and address any adverse reactions or conditions. The resident of the month meets
on a daily basis with the Medical Director, Dr. Robertson, to review all research patients’ status and
participate in training rounds.
CAPABILITIES TO SUPPORT DRUG DEVELOPMENT
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By providing specialty inpatient beds and highly trained nurses experienced in the meticulous scientific and
safety issues of pharmacodynamic/pharmacokinetic protocols, the CRC is poised to support rapid
development and Phase I testing. The CRC has ready access to the Vanderbilt Investigational Drug
Pharmacy, the Vanderbilt pathology laboratory for routine safety and outcome blood or urine analysis, and a
laboratory which can be mobilized as needed on site for unique non-commercial biomarker assay
development. Additionally, the CRC is fully equipped with infusion pumps, ECG machines, telemetry,
hemodynamic monitoring devices, refrigerators, centrifuges and freezers. With a capacity of 14 inpatient
beds, the CRC can complete a Phase I trial in a small number of subjects very quickly, an attractive feature to
industry-sponsored studies. Due to the availability of the CRC metabolic kitchen, specialty diets can be
provided to subjects who are participating in food effect studies of trials in new drug development. Although
Phase I trials most often include healthy volunteers, there are some circumstances where patients enroll in
such trials, such as patients who have terminal cancer or HIV and lack other treatment options.
PROTECTING THE SAFETY OF PARTICIPANTS AND ENSURING GCP
One of the most important goals of the CRC is to ensure participant and patient safety. The CRC has defined
safety standards and standard operating procedures for investigators conducting research in the CRC, and
these standards are enforced. For example, the PI for each research project is ultimately accountable for all
aspects of the daily care of study participants, whether inpatient or outpatient. If the PI is not a physician, he
or she must have a physician as a co-investigator or collaborator who assumes direct responsibility for patient
care. Research fellows and/or house officers working with the principal investigator may also assist in some
interactions with research participants. The CRC welcomes clinical research studies from regional
investigators, and the CRC will work to provide partnership with a credentialed Vanderbilt collaborator or other
credentialed member of the Vanderbilt Hospital medical staff to assure compliance with hospital policies and
patient safety. He or she must be experienced in the techniques and management of clinical research
including standardization. This experience is determined by recommendation of the department chair and by
observation of the CRC Director and Associate Directors, as well as by members of the SRC. In order to
further oversee the responsible investigator’s role, the Medical Director or one of the Associate Directors
rounds daily with the CRC resident, nursing staff, and dietary staff. The CRC is staffed by a resident physician
from the Department of Medicine 24 hours a day to provide clinical support to inpatients and outpatients. The
resident is responsible for any routine care of the patients admitted to the inpatient unit. The resident is
expected to evaluate each patient at admission and, in consultation with the PI, to order appropriate
laboratory studies. At the time of admission, the principal/responsible investigator meets with the resident to
discuss the nature of the research protocol, patient status, management plans, required diagnostic studies,
and specific protocol tasks. The investigator and resident reach an understanding about the duties of each,
especially concerning the allowable latitude of clinical management for compliance with the research protocol
and arrangements for communicating with the investigator. In addition to the medical resident assigned to the
CRC inpatient unit, emergency support is available 24 hours a day, seven days a week through Vanderbilt’s
Medicine Service and the Code Team. Emergency carts with defibrillators that include provisions for both
adult and pediatric resuscitation are maintained on the unit. All CRC and Pediatric CRC nurses are ACLS
certified. The CRC requires that each principal investigator or his or her representative be readily available to
the resident for management of emergencies. To ensure continuity of care of research participants, nurses
caring for individual participants or caring for participants on a particular protocol are re-assigned to those
areas during their subsequent shifts.
Implementing the protocol safely and with informed consent
CRC staff members understand that consenting a participant is a process. In addition to confirming that
signed informed consent is present prior to initiating research procedures, staff, using a checklist for
verification of good clinical practice principles routinely communicate with research participants to ensure
continued understanding and compliance with the protocol and willingness to continue to participate in the
research. VICTR has established procedures for ensuring improved compliance with protocol reviews and
consenting. CRC administrative and nursing representatives serve on the Pre-Review team for applications
presented to the Scientific Review Committee and become involved in the initial review of protocols. This prereview provides an opportunity to address nursing issues and concerns early in the process and assist
investigator with issues related to quality and subject safety. In addition, when the SRC approves nursing
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support for a study, whether inpatient or outpatient, the investigator and his/her research staff meet with the
nursing staff and other ancillary staff required for conduct of the protocol. During this face-to-face meeting, the
protocol is reviewed, detailed instructions are provided for research procedures, and physician order sets for
all doctors orders are created and entered into the computer.
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