The first priority of the TCH CTRC is to provide research nursing and exemplary patient care to children admitted under research protocols in a safe and family-centered caring environment. The inpatient unit is also active in providing care for non-research patients, including care for patients with cystic fibrosis. Clinical research facilities also include perinatal and pediatric "scatterbed nurses," an outpatient research unit, and a perinatal unit.
In addition to 18 research nurses, the TCH CTRC facilities are supported by a research bionutrition unit, core laboratory, and Scientific Advisory Committee, as well as biostatisticians, the informatics core, and the Research Subject Advocate Program of the CCTSI.
The CTRC also has a Molecular Genetics Core, utilizing the facilities and personnel at the DNA Diagnostic Laboratory at UCD. Services offered to investigators include purification of RNA and DNA, isolation of gene segments, and detection of mutations and polymorphisms.
TCH CTRC Inpatient Unit
Located on the 9th floor (West view) of TCH, the CTRC is a ten-bed inpatient unit within the hospital. The TCH CTRC staff provides unit coverage 24 hours a day, seven days a week, primarily for patient-oriented research. The patients range from healthy volunteers to acutely ill patients. Patient care and nursing expertise in research is provided. The unit primarily encompasses pediatric patients, but also accommodates adult patients. The TCH CTRC is unique in both its approach to patient care and its technical expertise.
TCH CTRC Outpatient Unit
The new research clinic is located on the 3rd floor of the Ambulatory Pavilion at TCH (Hallways D and E). There are 11 rooms (7 exam rooms plus 4 infusion rooms) to accommodate research outpatient visits. Depending upon the needs of approved protocols, research support can also be provided at offsite locations of TCH. Staffing consists of an Advanced Pediatric Nurse, a Registered Nurse, Healthcare Techs, and administrative support. Hours of operation are Monday through Friday, 8 a.m. to 5 p.m.
Perinatal “Scatterbed” Unit
The Perinatal CTRC "Scatterbed" Nurses who are based in the NICUs at TCH and the University of Colorado Hospital also provide Labor and Delivery and NICU coverage to Exempla St. Joseph Hospital and Denver Health. Though most studies are conducted during the day, Monday through Friday, the nurses do cover 24 hours a day, seven days a week. They identify potential research patients, consent, collect research samples and data, provide care for infants enrolled in complicated studies, and provide teaching and support for parents of study patients.
TCH CTRC "Scatterbed" Nurses
The TCH CTRC "Scatterbed" Research Nurse assists with CTRC-approved research studies at the bedside of patients (non-neonatal) at TCH who are who are too ill to be admitted to the TCH CTRC Inpatient Unit or not appropriate for the TCH CTRC Outpatient Unit. Coverage may include Surgical Services, Dental Clinic, Cardiac Intensive Care Unit, etc. Most studies are conducted Monday through Friday during the day. The nurse identifies potential research subjects, consents participants, and collects data and samples.
The Bionutrition Unit of the CTRC supports inpatient and outpatient studies at TCH, providing advice and services to investigators regarding study design, methodology, and outcome measures related to nutrition and relevant to the primary topic of the research protocol. Available services include assistance in development of nutrition components to protocols; dietary intake analysis and weighed food/dietary intakes; diet history; research diet design and implementation; resting energy expenditure measures using indirect calorimetry; physical activity assessment, growth and body composition measures, including skinfolds, BIA, DEXA, and circumferences; advice on biomarkers appropriate for outcomes of interest; and bone mineral density testing by DEXA.
The TCH CTRC Core Laboratory is staffed by senior medical technologists and is located at TCH. The Core Laboratory is available to develop and provide a broad spectrum of high-complexity chemical and immunological non-routine assays for CTRC-approved protocols. These assays are intended to complement assays undertaken in the investigator's own laboratory and are not available in the hospital clinical laboratory. The Core Lab is accredited through CAP (Commission on Laboratory Accreditation of the College of American Pathologists) and CLIA (Clinical Laboratory Improvement Act). Assays available include inflammatory mediators, cytokines and chemokines, bone metabolism, vitamins and antioxidants. New assays are being developed continually based upon the needs of investigators. For a full list of assays, see the main CCTSI website.
As part of the protocol submission process, PhD-level biostatisticians within the Colorado Biostatistical Consortium of the CCTSI provide evaluation and feedback to investigators prior to protocol review by the CTRC Scientific Advisory and Review Committee. Services include guidance on study design; sample size and power calculations; guidance on data abstraction and storage; test method selection and data analysis; manuscript writing support; Data Safety Management Board reports; and hypothesis generation.
The Research Informatics Integrated Core of the CCTSI supports investigators with data management and security needs in cooperation with hospital Information Systems groups. This includes a thorough review of all submitted research protocols, making technical suggestions regarding data collection/analysis and regulatory (HIPAA) compliance; database design and maintenance, data queries, assistance in analysis and reporting; secure data transfer between individuals and organizations; and training for new/current technology via the CTRC Learning Resource Center.
Research Subject Advocacy Program
The Research Subject Advocate (RSA) provides evaluation and assistance in formulating and implementing data and safety monitoring provisions for research involving human subjects (Data Safety Monitoring Plans, Data Safety Monitoring Boards); and consultation about research subject issues, consent, staff education, and presentations. The RSA is available to investigators, staff, and subjects with questions or concerns. Mentors, interns, and students may also perform independent study in bioethics (through UCD, UCB, and DU).
Scientific Advisory Committee
The Scientific and Review Advisory Committee (SARC) of the CCTSI meets twice a month to review and comment upon protocols submitted by investigators applying for CTRC support. The Pediatric SARC committee meetings alternate with the Adult SARC meetings; however, protocols involving both children and adults will be reviewed only once at a joint committee meeting.
There is also a course in the Clinical Sciences PhD Program (CLSC 7300) "General Clinical Research Center (GCRC) SAC Review Process" at the Graduate School of UCD, in which students participate in SAC review.
GCRC Advisory Committee
The GCRC Advisory Committee (GAC) meets quarterly and has oversight over administrative, budgetary and utilization issues. The GAC is composed of ten senior investigators who have knowledge of the functioning of the CTRC and other NIH and local programs, the CTRC Program Director, Associate Program Directors and CTRC management staff.