Research Resources Office at Texas Children`s Hospital, Baylor

advertisement
The buildings for the inpatient and outpatient facilities at Texas Children’s Hospital (TCH) and the supporting
research laboratories are adjacent and connected by either overhead walkways and/or underground tunnels.
Outpatient clinical trials are conducted in the clinics of participating sub-specialists or in the TCH Clinical
Research Center (CRC) located in the West Tower. Inpatient studies are conducted in the CRC or in the
individual subspecialty’s inpatient unit, located in the inpatient facilities that are located in the West Tower.
INPATIENT AND OUTPATIENT FACILITIES
Main Campus
Texas Children’s Hospital (TCH) is one the largest children’s hospital in the United States and the primary
teaching hospital for Baylor College of Medicine, Houston, TX. This full-care, state-of-the-art facility provides
inpatient and outpatient care in more than 40 specialties and subspecialties. TCH has 606 operating beds
including: 21 cardiovascular intensive care beds, 36 progressive care unit beds, 167 neonatal intensive care
unit beds, 31 pediatric intensive care beds, 15 BMT beds, and 336 acute care beds.
The main TCH main campus consists of a eight-building complex that includes: (a) the Abercrombie Building,
devoted to a variety of administrative and patient-oriented uses; (b) the West Tower, where the emergency
department, critical care units, operating
rooms, inpatient beds, and Clinical Research
Center are located; (c) a 16-story Clinical
Care Center, that houses all out-patient
clinics; (d) the Children’s Nutrition Research
Center, dedicated to nutrition research in the
neonate, infant and child; (e) the recently
renovated 20-story Feigin Center, which
provides a total of 540,010 sq. ft. of space for
state-of-the-art pediatric research initiatives
including the Sabin Vaccine Institute and a
GMP facility for cell and gene therapies; (f)
the Neurological Research Institute, the
world’s first basic research institute dedicated
to childhood neurological disesaes, opened in
the Spring of 2011 (not shown on map, a 5
minute walk from the Feigin Center); and (g)
Texas Children’s Pavilion for Women (opened
in the Spring of 2012 and connected by a twostory walkway to the Clinical Care Center and West tower), where gyencologists, obstetriciains and
neonatologists provide women, mothers and babies with a full continuum of high-quality care.
West Campus
Texas Children’s Hospital West Campus, which opened in 2010 in Katy, TX (West Houston), is designed to
incorporate the best practices in pediatric treatment environments and to provide the special accommodations
that families need in a children’s medical facility. The West Campus provides both outpatient and inpatient
services for children up to 18 years of age, and offers the only dedicated pediatric emergency room in greater
West Houston. The medical complex, totaling 490,000 square feet, was built in phases at an estimated cost of
$220 million.
Texas Children’s Health Plan
Texas Children's Health Plan is the nation's first health maintenance organization (HMO) created just for
children. It offers a primary-care network, specialists and a large hospital network. Texas Children's Health
Plan also offers great services to pregnant women and adults. Current membership in the Health Plan exceeds
217,000 members.
Texas Children’s Pediatric Associates
Texas Children’s Pediatric Associates (TCPA), a subsidiary of Texas Children’s Hospital, is the nation’s largest
group of general pediatricians, and has more than 40 locations throughout Houston and its surrounding
communities. TCPA was founded in 1995 with the mission of providing the finest pediatricians, dedicated to
delivering comprehensive, quality primary care and education to the children of the community. More than 140
TCPA board-certified or board-eligible pediatricians provide pediatric medical care recording more than 1
million visits annually. Practices are located in convenient urban or suburban areas to provide ease of access
to families. Today, TCPA’s pediatricians serve approximately 20 percent of Houston’s children.
CLINICAL RESEARCH FACILITIES
Research Resources Office at Texas Children’s Hospital, Baylor College of Medicine
The Research Resources Office (RRO) in the Department of Pediatrics at Baylor College of Medicine (BCM)
supports and promotes clinical and translational research endeavors of investigators and trainees at its partner
institution Texas Children’s Hospital. The goal of the RRO is to provide unified, coordinated and
comprehensive researcher-focused support and education for all regulatory aspects of both investigator
initiated, NIH cooperative group, and pharmaceutical industry studies, as well as provide centralized resources
for the pre- and post-award processes involved in developing and implementing the wide range of basic,
translational or clinical studies performed by TCH investigators. Services provided by the RRO include
comprehensive regulatory services, research nursing and coordination services, biostatistical support, an
expert research informatics group for database development and data management, and quality
assurance/quality control services. The RRO provides opportunities for training in federal regulations and local
policies regarding clinical research, and promotion of best practices to ensure the safe and ethical conduct in
clinical research.
The main offices of the RRO are located at Texas Children’s Hospital Feigin Center. This space includes
dedicated office and workspace for the RRO Medical Director, Administrative Director, clinical research staff,
regulatory coordinators, pre- and post-award specialists, and other administrative staff. Offices for
biostatisticians, software developers and bioinformaticians are also available in the Feigin Center.
Through collaboration with the Institute for Clinical and Translational Research at BCM, a multi-purpose web
portal to integrate and maintain the institutional knowledge to conduct clinical and translational research is
under development and its release is scheduled for the late spring of 2012.
Clinical Research Center (CRC) at Texas Children’s Hospital
Investigators have access to the Clinical Research Center at Texas Children’s Hospital, which hosts a discrete
inpatient and outpatient research unit to accommodate investigator needs. The CRC has been in operation for
over 48 years and is currently supported through TCH. The CRC has a 6 bed pediatric inpatient unit, 6
outpatient rooms, 1 room for metabolic studies and a fully operational metabolic kitchen. The CRC is staffed
24 hours per day 5 days per week and on alternating week-ends, by specially trained research nurses, dietary
staff, and administrative personnel. The CRC offers use of its facilities and resources for clinical studies which
have been approved through the Baylor IRB and the CRC Scientific Advisory Committee.
Investigational Drug Service (IDS) at Texas Children’s Hospital
The TCH IDS pharmacy supports clinical trials for all pediatric subspecialties. The Pharmacy is experienced in
the support of all types of clinical trials, including those involving investigational agents or requiring special
preparation, packaging, or labeling for blinded or randomized studies. Two dedicated pharmacists and one
pharmacy technician staff the IDS. The Investigational Drug Service occupies space distinct from the central
pharmacy, has adequate storage capabilities and dedicated cold storage and freezer space. It has the
responsibilities for randomizing patients onto clinical trials, controlling distribution of study agents, and
maintaining accountability of study drugs. The Investigational Drug Pharmacist reviews all protocols that
include investigational drugs and must sign off on them prior to IRB approval.
Download