Research Teams
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Vanderbilt Institute for Clinical and Translational Research
Clinical Research Center
Resource Overview
The Clinical Research Center provides space, hospitalization cost, laboratories, equipment, and supplies for clinical research. Center use is justified by research quality and significance, need for common facilities, and common usefulness or collective justification for facilities or personnel. The Center also serves as a resource for teaching students and a site for research in the methodology of patient care systems and apprenticeship for young clinical investigators.
It is equipped and staffed to care for hospitalized patients, with special examination and procedure rooms available for outpatient studies and for scientific protocols requiring a great deal of equipment. A patient waiting room and dining facilities are available for all scientific projects. The Center’s computer laboratory is equipped with hardware and software to assist in study planning, data management, and mathematical modeling. Scientific facilities include an assay development laboratory, a body composition and energy balance laboratory, a bionutrition unit with metabolic kitchen, energy and nutrient intake assessment capabilities, a locked medicine room, a specimen procedure room, centrifuges, and freezers for temporary sample storage.
Contact:
David Robertson, M.D
Director (3-6499)
Lynda Lane, MS, RN
Administrative Director (2-2390)
www.mc.vanderbilt.edu/gcrc
Nursing
Vanderbilt CRC is an all RN nursing staff specializing in clinical research with primary responsibility in the implementation and management of numerous, diverse protocols. The staff focuses on protocol specific procedures that require in-depth attention to detail while also maintaining subject’s comfort, safety and satisfaction. Clinical research practice embodies specialized skill sets to meet individual protocol requirements and open, on-going communication between the nurse and the study personnel to insure accuracy and performance consistency.
The staff is comprised of experienced and tenured nurses who come from all walks of nursing. Education is ongoing with mandatory competencies including BLS, ACLS, and chemotherapy administration. All nurses complete NIH Citi Modules, IRB, human subject protection, informed consent, and protocol management during orientation to the unit. Nurses new to the CRC are assigned an experienced preceptor who is committed to the training and development of the nurse for 90 days or until the nurse feels ready to be on their own.
Our constant, ever-changing, research environment requires scheduling flexibility and creativity that allows for the successful in-patient and outpatient studies of our adult and pediatric population.
Pediatric CRC
FACILITIES AND SUPPORT FOR PEDIATRIC RESEARCH
The Monroe Carell Jr. Children's Hospital at Vanderbilt (VCH) opened in February 2004. This eight floor, 616,785-square-foot facility houses more than 200 pediatric inpatient beds, a 35-bed PICU, 60-bed NICU, a 30-room pediatric emergency department, and the ancillary services needed to provide comprehensive pediatric care. There is an adjacent outpatient tower connected at all levels to the inpatient facilities. The Children’s Hospital provides the region with an up-to-date, state-of-the-art facility dedicated to meeting the unique healthcare needs of children, from newborns to young adults, by providing both primary care and subspecialty services. The referral area for the hospital includes Nashville, Middle Tennessee, southern Kentucky, and northern Alabama. Less than one year after its move into this facility, which is nationally recognized for its design, the Monroe Carell Jr. Children's Hospital at Vanderbilt was awarded the honor of ranking in the top 10 children's hospitals in the nation, according to Child magazine [10].
The Children’s Hospital Doctor’s Office Tower (DOT) provides more than 800,000 square feet of pediatric facilities. The DOT houses the newly established Pediatric Clinical Research Center in space generously donated by John Lee Jr. and now available exclusively for pediatric clinical research (see photograph). The facility administered and governed by the CRC allows easy access and parking, a separate waiting area accessible from the main elevator of the Children’s Hospital, a small check-in area, four outpatient exam rooms, two exam rooms with two-way mirrors for behavioral research, areas for specimen processing and sample storage convenient for both inpatient and outpatient sample processing, table-top centrifuges, a refrigerator and -20°C freezer, 10 computer workstations for use by investigators and other research staff, an administrative office, a large conference room, and storage areas for supplies.
This space is utilized primarily for outpatient research, but will be the focal point where investigators and coordinators come to process samples from inpatient studies, enter data on the many available computer workstations, and store their supplies for research studies. This new facility also provides: close proximity to ancillary pediatric services such as radiology, Child Life services, IV team, respiratory therapy, and pediatric occupational and physical therapy. Due to the distance from the Children’s Hospital, such pediatric ancillary services are no longer available in the existing adult CRC. Further, the Children’s Hospital incorporates a child-friendly environment with designated areas for play and interaction with other children. These additional facilities will provide space for nurses and investigators who need room for teaching, parent conferences, organizational and administrative meetings, directing patient care activities, data entry and analysis, and monitoring visits for the clinical trials.
Clinical Research Center Assay Development and Services Laboratory
Provides investigators with a service laboratory that analyzes and develops assays crucial to their research. Since its inception 46 years ago, the primary function of this core has been to modify and adapt to the demands of the investigators by performing specialized tests not available in the Medical Center. This core provides a structured database for sample registration, measurement, data storage and documentation. Investigators may access their data though a web-based interface.
Currently, the lab offers assays for the determination of urinary total nitrogen, urea, creatinine, sodium, potassium, glucose, calcium, magnesium and phosphorus for protocols that require higher accuracy and sensitivity than obtained from ancillary laboratories; in a more cost effective manner. Urinary total nitrogen is determined by a pyro-chemilluminescence method. Assays of urine and plasma catecholamine and their metabolites (DHPG, DOPA and DOPAC), using HPLC with electrochemical detection supports a wide range of research including the disorders of autonomic dysfunction, diabetes, hypertension and obesity.
In keeping with our mission to develop procedures that are crucial to new research initiatives, the lab has developed the ELISA assays of 6-sulfatoxymelatonin and salivary melatonin. The development of these will support a wide variety of projects slated for the Vanderbilt Sleep and Circadian Research Core. Melatonin determinations are not currently offered anywhere within the institution and we feel that the development of this resource will attract new investigators to the PCIR. New assays currently required by our investigators for development utilizing the ELISA technique include Nt-proBNP, salivary cortisol, and Cystatin C. Their development is recognized as critical because the new investigators will be conducting an investigation with high scientific merit and program relevance.
Informatics
The VICTR Informatics Core is a central location for data processing and management. Vanderbilt University, with collaboration from a consortium of institutional partners, has developed a software toolset and workflow methodology for electronic collection and management of research and clinical trial data. REDCap (Research Electronic Data Capture) data collection projects rely on a thorough study-specific data dictionary defined in an iterative self-documenting process by all members of the research team with planning assistance from the VICTR Informatics Core. The iterative testing process performed in REDCap development results in a well-planned data collection strategy for individual studies. The REDCap system provides a secure, web-based application that is flexible enough to be used for a variety of types of research, 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. The system offers easy data manipulation with audit trails and reporting for reporting, monitoring and querying patient records, and an automated export mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus).
In addition, the Informatics Core offers ECG bedside data collection, analysis, and archival; this methodology was developed and tested over the years, it includes data visualization and reporting essential for data interpretation. Heart Rate variability data collection, analysis, and archival; analysis tools where developed using Mat Lab to stream line the process. All carts are available to crc studies and can be scheduled for study visits.
Poster printing is provided for all protocols, additional information can be found here.
A3101 MCN houses the CRC's Informatics Lab with five dual-screen workstations hosting specialized software including SPSS, SAS, R, Mat Lab, Reference Manager, GraphPad Prism, Adobe Pro, NQuery Advisor, etc... for more information click here.
Research Subject Advocate
The Research Subject Advocate (RSA) supports the Principle Investigators and their research staffs by acting as a resource and educating them on human subject protection, compliance with regulatory obligations, and assuring the establishment of data and safety monitoring plans for all CRC clinical studies. The RSA assures the clinical studies are conducted in a safe and ethical manner. The RSA is an added resource to the program, and not a hindrance to research. The RSA does not replace the investigator, operational manager or program administrator's oversight of the research, but works in harmony with them throughout the study.
The RSA periodically serves as an unbiased observer during the recruitment and or enrollment process. The RSA may also communicate directly with research participants to help them understand study risks and ensure that their safety receives the highest priority.
The RSA is available on a 24-hour basis to assist with resolution of adverse events if they occur during a study. An important aspect of the RSA's role is to oversee reporting of adverse events and conflicts of interest to the IRBs. If an adverse event arises during a study, the RSA can be involved in the decision-making process related to restoring the patient's well-being, by communicating with the participant, emergency medical staff, CRC staff or others as necessary to resolve the situation. Moreover, in order to preserve participant safety, the RSA has the authority to temporarily halt or permanently close down any study if the risk to research participants is deemed too high.
In summary, RSAs monitor research activity through involvement in all stages of the clinical study process, from protocol design and recruitment to implementation and eventually data analysis. The goal of the RSA is not simply to ensure that investigators adhere to regulatory requirements, but ultimately to prevent harm or injury to individuals participating in research.
All studies supported by the VICTR CRC will have a written Data and Safety Monitoring Plan as part of the protocol. This is to:
To ensure the safety of the participants.
To ensure the safety of the participants.
To assure adherence to regulatory requirements for the protection of human subjects, as well as the management
of investigational agents if applicable.
To assure compliance with protocol requirements.
To assure the accuracy of recorded data versus source-documents.
To provide educational support to enhance protocol compliance, data management, compliance with regulatory
requirements and the audit process.
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