The University of Miami School of Medicine Clinical Research Center (UM-CRC) is an outpatient facility that provides centralized clinical research infrastructure to benefit investigators in multiple disciplines across UM. Located on the seventh floor of the Clinical Research Building (CRB), our mission is to provide a comfortable, safe and effective environment to conduct professional, high-quality research involving human subjects. This is achieved by providing the necessary environment, equipment and personnel to optimize research goals. The UM-CRC replaces the previous General Clinical Research Center (GCRC) model, and has been reorganized in response to national changes in funding of clinical research centers.
The UM-CRC now operates under a fee-for-service model that supports growth and investment in clinical and translational research at UM. While cost recovery is an essential component of successful operation, National Institutes of Health (NIH)-supported and unfunded junior investigators performing novel, career-developing studies will continue to enjoy partially subsidized services. Our cost recovery system has been designed to sustain and ultimately expand our services and mirrors a national shift in how human subjects research is supported at universities. Our administration will work with investigators and Clinical Research Initiation Services (CRIS) to develop appropriate study budgets for grants and industry supported studies.
Administration | Nursing | Bionutrition | Biostatistics | Research Subject Advocate | Lab | Facilities, Equipment & Services | Contact Us
The UM-CRC administrative staff manages the non-clinical operation of the Center including oversight of finances and billing and the process of applying for use of the UM-CRC.
The UM-CRC is staffed by professional research nurses who have experience and specific expertise in clinical research involving diverse study populations. The nursing staff provides research care for study participants while ensuring their safety and collaborates with investigators for the coordination and performance of clinical research studies. We encourage research teams to consult with our head nurse in advance to assist with the development of their research protocols. This will enhance the quality of work, streamline the application and implementation process and promote the necessary team effort required for the successful performance of team science.
The Bionutrition Core of the UM-CRC is led by a Licensed and Registered Dietitian (RD, LD/N), who is also a Certified Diabetes Educator (CDE) with experience in designing and conducting clinical research trials. The Bionutrition Core provides both resources and services for protocols that have a nutrition-related component. Services include support of protocol development, dietary assessment and analysis and nutrition education and intervention using the most sophisticated quantitative methods and nutrition software. The Core works with nursing and other support staff for training and collecting anthropometric measurements, including bioimpedance analysis and other standard anthropometric tests (e.g., skinfold measurements). In the near future, indirect calorimetry and bone densitometry and body composition (DEXA) testing will be available with the appropriate support staff. For studies requiring standardized meal services or study diets, the UM-CRC Bionutrition group works in collaboration with University of Miami Hospital Dietary Services to design, cook, and package study meals.
The Biostatistics group reviews the statistical plans of all studies submitted for approval by the UM-CRC. They are available for consultation for the development of future UM-CRC studies, and a statistician is available to the entire UM community for biostatistical consultation at the UM-CRC every Monday, Wednesday and Friday from 8:30 a.m. to 12:30 p.m. in room 730 of the CRB. Consultation topics may include assistance with study design, analytical approaches, power calculations and database construction. As part of this pilot project, the cost of the service is free.
Research Subject Advocate (RSA):
The role of the Research Subject Advocate (RSA) is to ensure that risks to participants in clinical research at the UM-CRC are minimized and that all studies are performed in an ethical manner. This is accomplished through multiple activities, including by reviewing all UM-CRC protocols for participant safety (both initial applications and annual updates), and by reporting adverse events to the UM-CRC Director, the Institutional Review Board (IRB) and appropriate federal agencies.
The primary role of the UM-CRC Core laboratory staff is to serve the needs of investigators involved in UM-CRC clinical protocols by providing routine sample collection, processing, and storage. The laboratory maintains a sample processing facility within close proximity to the exam rooms, aiding in rapid specimen processing.
Facilities, Equipment & Services:
The following facilities, equipment and services are available in the UM-CRC for researchers and their teams:
Facilities:
- Clinical examination rooms and invasive procedure rooms equipped with an exam table, infusion chair, vital signs monitor, and sink
- Phlebotomy room equipped with three infusion chairs
- Interview rooms equipped with internet access, table and chairs
- Small specimen processing room equipped with refrigerated centrifuges, standard microscope, refrigerator and a -20 freezer
- Specimen storage room equipped with a -80 freezer
Other Equipment:
- Automated vital signs monitor
- Pulse oximetry
- 12-lead ECG
- Intravenous infusion pumps
- OneTouch glucose monitor
Services:
- Phlebotomy
- Infusion studies
- Specimen processing laboratory services
- Short-term specimen storage
- Anthropometry
- Bone densitometry and body composition (DEXA)
- Nutritional consultation, dietary assessment and analysis
Other services that are not listed (i.e. cardiovascular imaging) are available throughout campus. The UM-CRC administrative staff can assist research teams with fostering collaborations for those services.
Note: It must be emphasized that the CRC is an outpatient facility and is not equipped for acute care needs. For studies beyond the scope of safety of the CRC, the staff is able to assist investigators in finding alternatives that meet their needs.
Clinical Research Center
University of Miami Miller School of Medicine
1120 NW 14th Street, 7th floor
Miami, FL 33136
Phone: 305-243-5012
Fax: 305-243-9586
