Welcome to Clinical Research Services (CRS)
Make Us a Partner in Your Research Plans
The CTSI Clinical Research Services (CRS) integrates eight clinical sites across San Francisco and Oakland that provide an array of adult and pediatric services and translate promising clinical research ideas into successful protocols. Whether you are a researcher, an industry collaborator, or a study participant, we will help you conduct your clinical research study.
- Guidelines & Application Process
- Contact us early to plan your research!
Launching a Cost Recovery Model
Clinical Research Services (CRS) is undergoing a transformation in its financial model to better accommodate the marked increase in the demand for our services by an ever widening group of UCSF investigators.
Clinical Research Services & Facilities
Click on the facility name or service of interest below for more information.
| San Francisco General Hospital | Moffitt Hospital Adult | Mount Zion Hospital | Moffitt Hospital Pediatrics & NCRC | Tenderloin Center | CHORI Children's Hospital Pediatrics & Adults | Kaiser Oakland Research Unit | Veterans Affairs Medical Center | |
|---|---|---|---|---|---|---|---|---|
| Inpatient Services | ||||||||
| Outpatient Services | ||||||||
| Nursing Services | ||||||||
| Nurse Practitioner | ||||||||
| Bionutrition Services | ||||||||
| Body Composition & Exercise Laboratories | ||||||||
| Clinical Research Coordinator Core | Available at any location | |||||||
| Participant Recruitment Services | Available at any location | |||||||
| Sample Processing | ||||||||
| Newborn Intensive Care | ||||||||
| Lead Lined Room | ||||||||
| Neurodevelopmental Evaluation | ||||||||
| Early-Phase Clinical Trial Unit | ||||||||
Nursing Services
The CRS nursing units are highly specialized patient care inpatient wards and outpatient units where researchers can learn about and conduct patient and disease-oriented research. In addition, the nursing staff is charged with administering patient care and patient care protocols that apply to the research participants. The nurses are trained to make complex research-related observations, perform precise collections of specimens, as well as data collection and documentation while providing exemplary patient care.
The CRS nurses incorporate the philosophy of translational and clinical research by promoting evidence-based practice through interdisciplinary collaboration amongst researchers, clinicians and nurses. They demonstrate the ability to synthesize and integrate nursing standards and clinical skills in order to achieve research goals.
The CRS nursing units are also research-training sites for nursing students who wish to advance their clinical research nursing knowledge as well as guide improvements in health services and patient care. Nurses learn to develop and design nursing procedures for research protocols in conjunction with clinical staff and researchers. They assume direct and continuing responsibility for the nursing care of research participants and develop analytical skills necessary to successfully identify clinical and research problems.
For additional information on services, or rates for industry-sponsored and intensive studies, please contact:
Hector Vizoso, RN, MSN
Administrative Nurse Manager, SFGH Site
415-206-3317
Email: hvizoso@sfghgcrc.ucsf.edu
Deanna Sheeley, RN
Director, Nursing Services Core, Moffitt Adult and Mount Zion Sites
415-353-1330
Email: deanna.sheeley@ucsfmedctr.org
Jeanie Addis
Administrative Nurse Manager, Moffitt-Pediatric Site
415-502-2683
Email: addisj@peds.ucsf.edu
Bionutrition Unit
The CRS Nutrition Core supports and promotes a wide variety of nutrition research services within the CTSI. Nutrition services are currently available at the 12 Moffitt, Mount Zion, Pediatric, SFGH, and CHORI (Oakland) sites. A staff of research dietitians and dietary assistants provide nutrition services to investigators with CRS approved protocols. We accommodate both inpatients and outpatients and provide the following specific services:
- Consultation services in the planning stages of the nutrition component of protocol development, grant and manuscript preparation.
- Development of specialized diets in our own metabolic kitchen, with independent chemical analyses to verify accuracy of diets prepared.
- Meal service ranging from regular diets for study participants to individualized, metabolic balance diets providing exact nutrient precision. Fully staffed metabolic kitchens are located at the Moffitt and SFGH sites.
- Dietary assessments, nutrition counseling and participant education.
- Customized nutrient analyses of diets using state of the art software, including NDS-R and Food Processor.
- A research training site for dietetic interns, graduate nutrition students, and post-doctoral individuals interested in human nutrition research.
Additional Information:
Services are offered on a cost-sharing or cost-recovery basis.
For additional information on services, or rates for industry-sponsored and intensive studies, please contact:
Cewin Chao, MS, RD, MBA
Nutrition Research Manager
415-476-9234
Email: Chaoce@gcrc.ucsf.edu
Body Composition and Exercise Laboratories
The CRS body composition and exercise laboratories provide a wide variety of services for measuring body composition and functional performance outcomes and consulting on use of these measurements in clinical studies. At the Moffitt and SFGH sites, CTSI-supported personnel are available to perform testing. We also offer training to PIs and study coordinators in the performance of some tests.
Body Composition and Bone Density:
Assessment of body composition and bone mineral density by dual-energy X-ray absorptiometry is available at Moffitt, SFGH, CHORI, Kaiser DOR, and VAMC. Other techniques available on a site-by-site basis include bioelectrical impedance analysis and anthropometry.
Exercise Testing
The Moffitt CRS has a fully equipped exercise laboratory that is staffed by a full-time ACSM-certified exercise specialist. The laboratory is equipped with a Quinton variable speed/grade treadmill that is interfaced with a 12-lead stress ECG system and a computerized respiratory gas analysis system. Bicycle and upper body ergometers are also available. Muscle function testing can be performed using a computerized Biodex isokinetic muscle testing machine. Other testing services include 6-minute walk test, gait-speed, shuttle walk, and similar tests, which can either be performed by CTSI personnel or study coordinators with training from CTSI personnel. These latter tests require minimal equipment and study coordinators can be trained to perform these tests at any CTSI site. In addition, an Acuson Sequoia C512 ultrasound machine is available for use by investigators who supply their own probe and study personnel.
Energy Expenditure
Indirect calorimetry for measurement of resting and energy expenditure and substrate utilization is available at SFGH, Moffitt, CHORI, and Kaiser DOR.
Other specialized equipment for measurement of body composition, functional performance, and energy expenditure is available on a site-by-site basis.
Services are offered on a cost-sharing or cost-recovery basis.
For further information regarding the exercise lab, or rates for industry-sponsored and intensive studies, please contact:
Kathleen Mulligan, PhD
Director
Email: kmulligan@sfghgcrc.ucsf.edu
Clinical Research Coordinator Core
Details to come
Danusia Filipowski
Director
415-476-4216
Email: kfilipowskid@gcrc.ucsf.edu
Participant Recruitment Services
Designed to help researchers at UCSF and affiliated institutions to enroll research participants into UCSF clinical studies; services include:
- Recruitment Analysis & Planning
- Cohort Identification & Direct Mail Recruitment
- Participant Recruitment Registry
- Recruitment Materials Toolkit (coming soon)
Learn more or contact us with questions:
415-514-8140
Email: recruitment@ucsf.edu
Sample Processing
The CRS Sample Processing Core Laboratories perform high quality and consistent specimen processing in support of protocols performed at the various CRS Sites.
The Sample Processing Laboratories provide investigators with skilled and consistent processing of blood, urine and other research samples. These services are customized to the needs of each individual protocol, and include state-of-the-art specimen tracking and inventory.
Wendy Staub
Sample Lab Manager
415-794-6460
Email: wendy.staub@ucsf.edu
Newborn Intensive Care
Heart Center
The ICN and Pediatric Heart Center have a large population of potential subjects for clinical research. In addition, an extensive neonatal clinical database, designed specifically to facilitate research, represents more than 30 years of morbidity and mortality data and is available for use by clinical investigators. The CRS Neonatal Clinical Research nurses facilitate research in both of these units by providing support in the following areas:
- review of protocol design for feasibility
- assist with the IRB and PCRC Advisory Committee application process
- develop protocol specific standard operating procedures
- recruitment and enrollment
- parent education and support
- protocol implementation
- biological specimen collection
- assist with research procedures and interventions
- monitor responses to research interventions
- research record management
- application of aEEG monitoring
- MRI imaging
- safe off-unit transport of critically ill infants for research studies and procedures
The Research nurses screen patients, identify potential study subjects, and identify the appropriate project for them to participate in (based on eligibility criteria and the accrual guidelines created by the coordinating committees (see below)).
Both the ICN and Pediatric Heart Center are closed research units. Each unit has its own coordinating committee to provide rapid screens of preliminary potential research proposals from investigators who want to use the ICN or Pediatric Heart Center patient population. The coordinating committees make decisions about the appropriateness of the trial and its feasibility of successful accomplishment. They base their decisions on the current studies being performed in the units, the best use of resources, potential enrollment conflicts with other studies, and the potential for collaborating or bundling studies with other studies. The coordinating committees are responsible for determining how patients enter studies when several studies using the same patient population are ongoing in the unit. The coordinating committees assist investigators in planning and carrying out their studies.
Currently the ICN and Pediatric Heart Center are supporting projects from the following subspecialties: pediatric anesthesia, cardiology, cardiothoracic surgery, immunology, genetics, GI, neonatology, neurology, nursing, obstetrics, ophthalmology, pediatric surgery, radiology and the Fetal Treatment Center.
If you would like to conduct a research study utilizing ICN or Pediatric Heart Center patients, you will need to follow the following steps:
- Consult with a member of the Neonatology (Ron Clyman) or Heart Center (Phil Moore) coordinating committees or one of the Pediatric Critical Care Research nurses (Jill Imamura-Ching) regarding the feasibility of doing your study in one of the units.
- Once reviewed, submit the protocol to both the Human Research Committee (IRB) and the Pediatric Clinical Research Center (PCRC)
For additional information on services, or rates for industry-sponsored and intensive studies, please contact:
Jill Imamura-Ching, RN
415-476-9823
Email: Jill.Imamura-Ching@ucsfmedctr.org
Ron Clyman, MD
415-476-4462
Email: ClymanR@peds.ucsf.edu
Phil Moore, MD
353-4143
Email: Phillip.Moore@ucsf.edu
PICU - Pediatric Critical Care Research Nursing Unit
The CTSI Pediatric Critical Care Clinical Research nurses facilitate the research process through support of multidisciplinary investigators in the conduct of innovative clinical research in the UCSF Neonatal (NICU) and Pediatric Cardiac Intensive Care Units (PCIC). Research projects represent pediatric anesthesia, cardiology, cardiothoracic surgery, immunology, genetics, GI, neonatology, neurology, nursing, obstetrics, ophthalmology, pediatric surgery, radiology and the Fetal Treatment Center. An extensive neonatal clinical database, designed specifically to facilitate research, represents more than 30 years of morbidity and mortality data and is available for use by clinical investigators.
A novel aspect of the critical research nurses' expertise has been the development of technological systems, such as an MRI neonatal incubator, and procedures to take complex patient monitoring and support systems from the intensive care units to procedural areas within the medical center. These methods are now enabling access to research technologies, such as neuroimaging, which has become a major outcome measure in new research protocols.
Expert research nurses, skilled in the care of critically ill infants, provide support in the following areas:
- review of protocol design for feasibility
- assist with the IRB and PCRC Advisory Committee application process
- develop protocol specific standard operating procedures
- screen and identify eligible patients
- recruitment and enrollment
- parent education and support
- protocol implementation
- biological specimen collection
- assist with research procedures and interventions
- monitor responses to research interventions
- research record management
Jill Imamura-Ching, RN
415-476-9823
Email: Jill.Imamura-Ching@ucsfmedctr.org
Lead Lined Room (Children)
A private inpatient room in the pediatric research center is fully lead-lined and equipped with a ceiling radiation monitor to allow the infusion of radioactive materials such as iodinated MIBG. The lead-lined room has been used for investigating groundbreaking treatments for neuroblastoma with MIBG.
Leslie Mullin
Email: lmullin@peds.ucsf.edu
Children Neurodevelopmental Evaluation
Dr. Rita Jeremy provides a variety of neuropsychological assessments for children who participate in research under the auspices of the UCSF PCRC as well as Children's Hospital in Oakland. In addition, she is available to provide consultation on study design and to participate in the dissemination of study findings. The availability of Dr. Jeremy's expertise allows the careful analysis of neuropsychological primary endpoints for multiple studies unique to a pediatric population and prospective in nature.
Rita Jeremy, PhD
Phone 415-502-5398
Fax 415-502-5401
Email: jeremyr@peds.ucsf.edu
Early-Phase Clinical Trial Unit
The CRS Early-Phase Trial Unit has the capability to efficiently screen, assess, and treat patients interested in novel therapies. While this unit represents a collaborative effort with the Helen Diller Family Comprehensive Cancer Center and is currently focused mainly on cancer, support is not limited to cancer investigators or cancer patients and has expanded to non-cancer Phase I trials.
The unit seeks to leverage the expertise of UCSF investigators in multiple disciplines, and to bring new scientific discoveries and first-in-human novel agents to patients with incurable disease. Studies of interests include novel treatment modalities sponsored by NIH, pharmaceutical sponsors, and the University of California drug discovery effort.
Team members are comprised of oncologists, translational scientists, disease dedicated surgeons and pathologists, translational pharmacologist, investigational pharmacists, and anthropologists, as well as a group of highly specialized high-tech imaging experts.
A center-wide integrated business agreement allows for centralized treatment and assessment of all patient needs, integrating administration of standard therapies, intense medical and cardiac monitoring with administration of novel therapies, and pharmacodynamic and pharmacological endpoint assessments.
For further information please contact:
Pamela N Munster, MD
Professor of Medicine and Unit Director
Email: pmunster@medicine.ucsf.edu