Clinical Research Unit of Cleveland Clinic

The medical treatments you or family members receive today are the result of clinical research studies conducted to develop new treatments and improve on current treatments. Since its inception, Cleveland Clinic has been dedicated to the delivery of world-class medical care, medical education, and research into diseases to improve health. The Clinical Research Unit is where Cleveland Clinic researchers can conduct medical studies, and where participants in research studies can make a difference.

Conducting Research with the Clinical Research Unit

    Apply to use Clinical Research Unit services
  • If this is your first experience with the CRU, read the Investigator Manual first. The Investigator Manual includes an overview of the application process, including the scientific review and how we can help you develop your protocol.
    Talk to us first.
  • Talk to us before you fill out the application. Get tips and help with the application, if you need it.
  • Administrator for initial questions, for questions about resources available.
  • Biostatistician for study design and planning for data analysis.
  • Nurse Manager to discuss study logistics and identify the resources needed to carryout the protocol, so that they can be fully identified on the application form
  • Sample Processing Lab can review your sample processing and handling needs.
  • The Core Lab Director is available to discuss needs for specialized services from Lerner Core Services.
  • Research Subject Advocate for help with a Data Safety Monitoring Plan. All protocols on are required to have a DSMP. Can also be consulted to review consent form language.
    Submit your application for scientific and resource review.
  • Applications received by the first of each month are reviewed within that month. Determinations are communicated by the end of each month.
  • Application flow chart
    Receive your Resource Letter
  • Upon successful review, you will receive a letter outlining the resources being made available to your project. To accept, please sign and return the letter.
    Project Initiation Meeting
  • To start your project on the Clinical Research Unit, a meeting is held between your study team and the personnel on the Unit who will be involved. This assures all personnel are trained and aware of the exact protocol requirements and procedures.
    Give us credit !
  • This helps us keep our NIH funding! All publications resulting from the use of Clinical Research Unit resources need to include this acknowledgement:

    " This publication was made possible by the Case Western Reserve University/Cleveland Clinic CTSA Grant Number UL1 RR024989 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health and NIH roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH."

Advancing Medical Knowledge

The Cleveland Clinic’s Clinical Research Unit (CRU) is designed to provide an optimal clinical research setting for research participants involved in studies by medical investigators. Volunteer participants are at the heart of our efforts to further the clinical research process and advance medical knowledge. The Unit provides a safe, controlled environment for medical investigators to conduct state-of-the-art patient-oriented studies.

Services

Clinical Research Unit resources consist of nursing and laboratory personnel, laboratory facilities, examination and procedure rooms and specialized research equipment. The primary facility is located at Desk M51 on the main campus.

Who Can Use the Unit?

Seasoned clinical investigators, as well as investigators initiating research or in training, who have research project funding from the NIH, other Federal agencies, state and local entities, the private sector, or other peer-reviewed sources are eligible to apply to use the resources of the Clinical Research Unit. Pilot projects are also considered eligible if there is a plan to seek extramural funding.

The Cleveland Clinic CRU is supported by a Clinical and Translational Science Award (CTSA) from the National Center for Advancing Translational Sciences (NCATS). Richard Rudick, M.D., is the Principal Investigator at Cleveland Clinic. This funding created a local consortium that includes Cleveland Clinic, Case Western Reserve University, MetroHealth Medical Center and University Hospital Case Medical Center. This local consortium, known as the Clinical & Translational Science Collaborative (CTSC), allows timely collaboration and shared resources, ultimately enabling researchers to provide new treatments more quickly to patients. The local consortium is part of the national CTSA research consortium, with the goal of transforming clinical and translational research.

Administration

For initial questions:

  • Administrative Director
  • Charlotte Bhasin
  • Phone:216-444-5113
  • Fax: 216-636-3329
  • Email: bhasinc@ccf.org

Research Subject Advocacy

For consent and DSMP consults:

  • Research Subject Advocate (RSA)
  • Sumita Khatri, M.D.
  • Phone:216-445-1701
  • Fax: 216-636-3329
  • Email: khatris@ccf.org



Biostatistics / Study Design

For study design and planning for data analysis:

  • Biostatistician
  • Jim Bena, MS
  • Phone: 216-445-2336
  • Fax: 216-636-3329
  • E-mail: benaj@ccf.org

Laboratory Services

To review lab sample processing needs:

  • Lead Research Technologist
  • Teresa Markle
  • Phone:216-445-5740
  • Fax: 216-636-3329
  • Email: marklet@ccf.org
Reizes
  • Laboratory Manager
  • Ofer Reizes, PhD
  • Phone: 216-445-0880
  • Fax: 216-444-9404
  • E-mail: reizeso@ccf.org

Nursing

To discuss study logistics and identify needed resources:

  • Nurse Manager
  • Kay Stelmach, R.N., R.R.T.
  • Phone:216-444-3588
  • Fax: 216-636-3329
  • Email: stelmak@ccf.org

Informatics

  • Informatics Systems Analyst
  • Chuck Trunick, B.B.A.
  • Phone: 216-445-6933
  • Fax: 216-636-3329
  • E-mail: trunicc@ccf.org

Leadership

  • Program Director
  • Serpil Erzurum, M.D.
  • Phone:216-445-7191
  • Fax: 216-636-0104
  • Email: erzurus@ccf.org
  • Associate Program Director
  • Lara Jehi, M.D.
  • Phone:216-444-3309
  • Fax: 216-636-3329
  • Email:jehil@ccf.org
 
  • Associate Program Director
  • W.H. Wilson Tang, M.D.
  • Phone:216-444-2121
  • Fax: 216-636-3329
  • Email: tangw@ccf.org

Federal regulations and policies protect subjects

Federal regulations and policies protect subjects in clinical research protocols, ensuring that their safety is given the highest priority. These regulations complement the policies of academic institutions that have Clinical Research Units. Proper performance of research consent and oversight procedures makes demands on the time of already-busy clinical researchers.

To address these demands, the National Center for Research Resources has created a Research Subject Advocate (RSA) position within each Clinical Research Unit. The purpose of this position is to assure that all steps are taken to maximize patient safety as detailed in the protocols approved by the Institutional Review Board (IRB). Cleveland Clinic's RSA is responsible for reporting of all Clinical Research Unit adverse events (AEs).

Get help and assistance from the Research Subject Advocate

Both expected and non-expected events need to be recorded on the Clinical Research Unit Adverse Event report form

Clinical Research Unit Research Subject

  • Adverse Event Reporting Guidelines
    • |
  • Adverse Event Report
  • (DSMP) Data and Safety Monitoring Plan Guidelines
    • |
  • (DSMB) Data and Safety Monitoring Board Guidelines
    • |
  • CRU Unanticipated Problem Reporting Guidelines
    • |
  • Unanticipated Problem Report

Our participants are equal and essential members in the clinical research process.

Without the generosity of our volunteers, we could not advance medical care.


Learn more about becoming a participant


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Participate today


Join ResearchMatch, a free national volunteer recruitment registry
 
  • Search for studies at Cleveland Clinic with iConnect
  • For educational information in many different languages, visit CISCRP - The Center for Information and Study on Clinical Research Participation
  • Sign up for our newsletters
 

Research Resources and Services of the Clinical Research Unit

The Clinical Research Unit (CRU) is dedicated to helping investigators advance patient-oriented research. The CRU enables Cleveland Clinic research to be brought to the patient in a comprehensive, timely, safe and effective way, promoting rapid translation of findings in the lab to the patient. The Unit provides outstanding controlled inpatient and outpatient human subject research environments, personnel, and core lab services.

The CRU has provided research nursing and laboratory support for over 300 investigators to date. More than 200 research projects representing over 35 clinical specialties have been conducted with support from the unit. As a shared resource, it affords greater capacity and opportunity for clinical and translational research to be conducted, and through economies of scale, promotes the efficient use of funding for personnel and physical resources.

RESEARCH PATIENT CARE RESOURCES
To discuss your project, contact:
Kay Stelmach 216-444-3588 stelmak@ccf.org

The CRU comprises nursing staff experienced in both clinical care and research procedures. The CRU ensures a culturally sensitive and welcoming clinical research environment for volunteer research participants, at the same time ensuring proper adherence to protocols. Services range from ordinary specimen and data collection procedures (i.e. phlebotomy, electrocardiograms, bronchoscopies, exercise testing) to the extraordinary – such as our unique project involving apheresis and subsequent elutriation.

Research Patient Care Resources include, but are not limited to:

  • Personnel support to execute clinical research protocols so that studies are conducted effectively, efficiently and with accurate data collection
  • Participant recruitment assistance
  • Inpatient research-only overnight stays
  • Outpatient examination room space
  • Outpatient protocol nurse visits
  • Specialized procedure rooms
  • Metabolic meal preparation; research dietician consultation
  • Human exercise performance measurement lab

CORE LABORTORY SERVICES
To discuss your project, contact:
Teresa Markle 216-445-5470 marklet@ccf.org

The Core Laboratory provides direct bedside-to-bench processing, making it the ideal location for consistent, high-quality sample processing. By conforming to consistent procedures, as specified by each protocol, 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.

Core Laboratory Resources include, but are not limited to:

  • Laboratory technical support to conduct processing of the highest consistency and quality, including documentation of variations and observations made during the procedures
  • Creation of detailed SOPs
  • Basic or complex processing; Specialized processing techniques at the direction of the PI
  • Receipt of samples either collected by CRU nursing staff, or from other clinical environments where human research specimens are procured, such as surgical suites and outpatient clinics
  • Cell isolations (Ficoll or CPT methods)
  • Elutriation services, yielding high numbers of purified platelets, lymphocytes and monocytes distributed to basic science researchers
  • Shipment or courier transport of samples to other locations (DOT/IATA certified)
  • Analytical resources
    • Abbott Cell Dyn for cell counting
    • Molecular Devices plate reader and spectrophotometer
    • YSI glucose/lactate analyzers

Parkinson's Pump Gets Press: Several regional news outlets recently featured a Cleveland Clinic patient who has had remarkable success with an experimental treatment method for Parkinson's disease. In a clinical trial led by Hubert Fernandez, MD, head of movement disorders at the Center for Neurological Restoration in the Cleveland Clinic's Neurological Institute, patients receive a well-known Parkinson's medication, levodopa, through a tube surgically inserted into their stomachs. The tube is attached to a pump that delivers a steady stream of the medicine, in gel form, directly into the digestive tract, where it is absorbed by the small intestine. The device, which has shown promise in stabilizing treatment effects and reducing symptoms, could improve quality of life for Parkinson's sufferers. Dr. Fernandez anticipates FDA approval in the next couple years. WATCH THE STORY (WDIV-TV, Detroit), READ THE STORY (Everyday Health)

Improved drug delivery, making a difference: Hubert Fernandez, MD, Center for Neurological Restoration, is leading a clinical trial designed to improve drug delivery to patients with advanced Parkinson's disease. As the disease progresses, normally effective drugs provide relief for a decreasing amount of time. The Levodopa Carbidopa Intestinal Gel pump is being tested as a way to deliver the medication directly and continuously to the intestines, where it can more quickly and reliably take effect. This also frees the patient from frequently taking medication. The Clinical Research Unit is facilitating the study. See www.wkyc.com.

Richard A. Rudick, MD, Co-Principal Investigator of the Clinical and Translational Science Collaborative (CTSC), is the first recipient of the Case Western Reserve Medal, honoring excellence in health science innovation. This newly initiated award is the highest honor bestowed by the Case Western Reserve University School of Medicine. Dr. Rudick achieved national prominence as a clinician and research investigator in multiple sclerosis. He initiated Cleveland Clinic's Clinical Research Unit in 2003, and continues to oversee its operation as Co-Principal Investigator of the CTSC. He is a champion of collaboration to advance research for patient care.

The nursing team of the Clinical Research Unit not only masters diverse and complex study procedures, they care for the patients' well-being and safety, while remaining attuned to the quality and integrity of the research samples and data collected. Their Cleveland Clinic Caregiver Excellence Award is for the quality and compassionate care the nursing team provides to our study patients.

At the heart of Cleveland Clinic's mission is research, with emphasis on quality and leadership. The M51 Core Lab Team has demonstrated dedication to the accurate and rigorous processing of every human research sample. The team handled 17,000 samples last year! They received the Cleveland Clinic Caregiver Excellence Award for their attention to details, an essential element of high quality research results. Their dedication has resulted in repeated instances in which investigators all over the country remark that samples processed by the Cleveland Clinic's M51 Core Lab are of consistently of better quality.