Clinical Research Unit Services (CRUS) Laboratory Resources

Cleveland Clinic

Overview
The Cleveland Clinic's Core Lab performs research sample processing for investigators, ranging from basic (centrifugation and aliquotting) to highly complex protocols, at the direction of the PI. It is the ideal location for consistent, high-quality sample processing, allowing for direct bedside-to-bench processing. Located within the hospital, samples may be collected at M51 by the Clinical Research Unit's nursing staff, or samples can be received from other clinical environments where human research specimens are collected, such as surgical suites and outpatient clinics.
The Core Lab also assists investigators in study protocol development in regard to specimen collection requirements, processing decisions, and estimates of fees. Consultation early in a project's inception is encouraged.
The laboratory operates on weekdays during daytime business hours. Special arrangements for weekends and evenings may be made on a limited basis.

Processing Resource
For each study, detailed SOPs are developed, outlining each step of procedures followed and provides for documenting variations or observations made during the process. By conforming to consistent processing of biological specimens, the lab aims to greatly reduce confounding variations that could occur due to differences in specimen handling. This detail-oriented handling is an essential element of the pre-analytical phase to ensure the most robust results can be obtained. Specialized processing techniques can be accommodated at the direction of the PI. Cell isolations are also performed.

The core lab accepts biospecimens such as blood, urine, saliva, BAL, and biopsies. Specimens can be frozen at -20°C or -70°C in units continually monitored to maintain temperature. However, it should be noted that the laboratory does not provide long-term storage. Biospecimens can be distributed by lab personnel, courier, or shipment on dry ice to clinical and research labs. All personnel are trained and certified to ship hazardous goods

Analytical Resource
Analytical services are available at the direction of the PI. On-site equipment includes Molecular Devices plate reader for ELISA assays with spectrophotometer for colorimetric assays, three YSI glucose analyzers, and an Abbott Cell Dyn for cell counting. The Core Lab maintains close working relationships with the CTSC entities at University Hospitals (UH) and MetroHealth Medical Center (MHMC) for additional analytic services as needed.

Access to Services
An application for services must be reviewed and approved. The Clinical Research Unit's Core Laboratory resource is available to all clinical and basic science investigators in the Cleveland area. The Core Lab operates on a fee-for-service basis, with subsidies for NIH sponsored investigators. Estimates of fees can be provided. All specimens must be collected on IRB-approved projects

Contact Information
Ofer Reizes, PhD, Director
Office Phone: 216 445-6613
Email: reizeso@ccf.org

Lab Location
Cleveland Clinic
9500 Euclid Ave., Desk M51-23
Lab Phone: 216-455-5470

MetroHealth Medical Center

Overview
The MetroHealth Biospecimen Core (CRUBC) provides complete management of research biospecimens including collection, processing, storage and shipping. The laboratory is composed of a processing facility and a point of care testing lab for select analytes. The CRUBC laboratory resource is available to all clinical and basic science investigators in the Cleveland area. The CRUBC staff provides specialized laboratory support, customized to meet the needs of investigators in all aspects of studies, including protocol development and budget preparation. Consultation early in the project development is encouraged. In addition, the CRUBC serves as a vital interface with clinical trial sponsors and study coordinators to assure protocol sample collection and processing instructions are completed and performed accurate.

Processing Resources
The CRUBC is located within the CTSC Clinical Research Unit at MetroHealth Medical Center (MHMC). The laboratory receives specimens from outside the institution and by courier from local hospitals and health centers such as Cleveland Clinic Foundation (CCF), University Hospitals Cleveland Medical Center (UHCMC) and Veterans Administration Hospital (VA). Blood is processed per protocol. Biospecimens can be distributed by courier or shipment on dry ice to clinical and research laboratories locally, nationally or internationally. For NIH and clinical trials, the CRUBC manages samples collected at multiple sites including UH, CCF, MHMC, the VA, in the community and at other universities. The CRUBC maintains close working relationships with the CTSC entities at the CCF and UHCMC. All personnel are trained to ship hazardous goods. The CRUBC can provide electronically monitored storage of samples to be in future analyses.

Point of Care Analytic Resources
The CLIA certified CRUBC laboratory provides analytical support for biospecimens obtained as part of clinical trials as well as supporting basic scientists. Point of care testing includes glucose analysis by YSI, urinalysis by dip stick method and qualitative detection of HCG by SP brand rapid test. A wide range of analytes including cytokines and hormones as well as specialized tests may be requested from the Bioanalytical CORE at the CTSC laboratory at UHCMC. The MetroHealth CRUBC laboratory manager will assist investigators with such requests.

Access to Services
All projects must be IRB approved. The rates are determined according to authorship of the project.

Contact Information
Jacqueline Bjaloncik, M.S., Manager
Office Phone: 216-778-8899
jbjaloncik@metrohealth.org

Laboratory Location:
MetroHealth Medical Center
Hamann Building Room S-224
Laboratory phone: 216-778-3706

University Hospitals Cleveland Medical Center

Overview
The Human Specimen Core (HSC) provides complete management of research biospecimens including collection, processing, storage, and analysis. The laboratory resource is available to all clinical and basic science investigators in the Cleveland area. All HSC activities are tracked using an electronic database. The HSC provides expert assistance tailored to meet the needs of investigators in all aspects of studies including protocol development and budget preparation. Consultation early in the project development is encouraged. In addition, the HSC serves as a vital interface with trial sponsors and study coordinators to assure protocol sample collection and processing instructions are complete and accurate.

The laboratory is composed of two parts, the processing facility and the analytical lab.

Processing Resource
The HSC is located within University Hospitals Cleveland Medical Center (UHCMC) in close proximity to the Dahms Clinical Research (DCRU) nursing unit and the many other clinical environments where human specimens are collected such as the OR and outpatient clinics. The lab can receive specimens shipped from outside institutions and by courier from hospitals and health centers such as CCF, MetroHealth, and the VA. Blood is processed for serum/plasma, PBMCs, etc. Specimens can be stored at -20°C, -70°C, and in vapor phase LN2. Biospecimens can be distributed by lab personnel, courier, or shipment on dry ice to clinical and research labs. For clinical trials, the core can manage samples collected at multiple sites including UH, CCF, MetroHealth, the VA, in the community, and at other universities. The HSC maintains close working relationships with the CTSC entities at the Cleveland Clinic Foundation (CCF) and MetroHealth Medical Center (MHMC). All personnel are trained to ship hazardous goods. The HSC can provide electronically monitored storage for samples to be used in future analyses.

Analytical Resource
The CLIA certified HSC laboratory provides analytical support for biospecimens obtained as part of clinical trials as well as supporting basic scientists. Laboratory instrumentation includes a Meso Scale Discovery multiplex analyzer, a Molecular Devices SpectraMax 190 plate reader and dedicated glucose analyzers. The test menu includes a wide range of analytes including cytokines and hormones. Specialized tests are available on request.

Access to Services
The HSC operates on a fee for service basis. All projects must be IRB approved. The CRU resource request form will allow you to select Lab Only services. The rates are determined according to the funding source of the project.

Contact Information
Sarah Scott, M.S.
Office phone: 216-844-1369
Sarah.Scott@UHHospitals.org

Location
University Hospitals Cleveland Medical Center
WEARN Bldg. Room 508