Guide to Clinical Research Unit Services

Guide to Clinical Research Unit Services

Purpose / Clinical Research Unit Services helps make research happen. Approved medical investigators use the Unit’s Services to conduct pioneering, innovative patient-oriented studies that lead to advances in medical knowledge. To achieve this purpose, Clinical Research Unit Services provides experienced research personnel and a controlled clinical research environment, set apart from clinical care areas, for research participants to be confidently involved in clinical research studies.
Research Resources Available / Pre-proposal consultation: How can the Clinical Research Unit assist your next research project? Utilize the experience of the CRU staff by meeting with them as you start to plan a new grant proposal. Ideas about study logistics to enhance implementation feasibility can be helpful to planning a successful study. Request a CRU Consultation meeting by emailing .
Research Personnel: Patient care personnel who can conduct study visits, pre-analytic laboratory personnel, study coordination personnel
Facilities & Equipment: Examination and procedure rooms, research admissions, specialized research equipment, on-site pre-analytical sample-processing lab
(Please see a detailed listing of resources and services at the end of this document.)
Location and Hours of Operation / The Clinical Research Unit (CRU) physical facility is located at Desk M51 on Cleveland Clinic’s Main Campus.
For Outpatient Study Visits:
·  Outpatient research appointments are generally scheduled between 7am and 5pm weekdays. Weekday evening and weekend appointments are available by pre-arrangement with the Research Nurse Manager.
Overnight Admissions to M51:
·  Overnight research admissions are planned and scheduled directly with the Research Nurse Manager
*Closed official Cleveland Clinic Holidays
Principal Investigator Credentials / All Cleveland Clinic Main Campus Professional Staff members, residents, fellows, medical students, and allied health professionals are eligible to be Principal Investigators (PIs) on studies conducted within the Clinical Research Unit. If the Principal Investigator does not hold an active appointment of Professional Staff of Cleveland Clinic, a Staff Sponsor/Mentor holding such appointment must be named on the application and submit a letter describing the mentoring plan.
CRU Request Form / CRU Request Form and instructions can be found at: www.clevelandclinic.org/cru
Complete Submission / Complete submissions consist of the CRU Request for Resources Form, PI Biosketch, Staff Sponsor Biosketch (if applicable), the research protocol, and consent forms. Incomplete requests cannot be reviewed.
Submission Deadlines / Please allow all CRU requests 10-14 business days for review
Fees/Costs / NIH’s National Center for Advancing Translational Sciences (NCATS) announced that all study-related services received at Clinical Research Units will need to be expensed to the investigator’s funding source as of June 1, 2017. The expense of study-specific visits will no longer be an allowable cost on the CTSA grant that funds the CRU. This is a transition year for Cleveland Clinic’s CRU to convert to a Service Center model.
o  Existing studies, currently approved and using the Clinical Research Unit that complete prior to June 1, 2017, will incur no charges.
o  Existing studies, currently approved and using the Clinical Research Unit that need to continue past June 1, 2017 should contact the CRU for a cost determination of services needed after June 1, 2017 to seek/plan for alternate/additional funding.
o  New studies, Renewals, and/or Competing grant applications and/or resubmissions of originally unsuccessful proposals planning to use the CRU will be expected to include costs of CRU services in their respective applications and proposal budgets. Please contact the CRU at least 10 business days before the grant routing/submission.
o  Industry-sponsored studies: The CRU charges for industry-sponsored studies remain unchanged.
Project Initiation Meeting / A project initiation meeting is required prior to scheduling any research participants on the Unit. At this meeting, the PI and study team meet with key members of the Clinical Research Unit to discuss the detailed logistics of study implementation.
Change of Principal Investigator / In the event there is a change of PI, the CRU must be notified by forwarding the IRB’s ‘Approval of Change of PI’ to .
CRU grant
Acknowledgement in publications is required. NIH Public Access policy applies. / NIH Grants Policy requires researchers to acknowledge Federal funding when issuing publications, scientific presentations, press releases, and other products describing projects or programs funded in whole or in part with Federal funds. Receiving resources from the Clinical Research Unit constitutes the use of Federal monies and obligates investigators to inform the public that the research was conducted with taxpayer dollars.
All researchers should cite grant UL1TR000439: “This publication was made possible by the Case Western Reserve University/Cleveland Clinic CTSA Grant Number UL1TR000439 from the National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCATS or NIH."

SERVICES

Protocol Specific Nursing / Research Patient Care Services
Our specially trained research nurses are 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 specimen and data collection procedures such as phlebotomy and electrocardiograms to bronchoscopies, exercise testing, drug administration and glucose monitoring.
Nursing personnel may be requested for off-unit services (to other main campus locations or CCHS locations) on a case-by-case basis. We also provide direct nursing care with dedicated research inpatient beds for studies that need pharmacokinetics, extended monitoring and sleep studies. Services include, but are not limited to: / ·  Pre-proposal study logistics planning
·  Creation of detailed nursing procedure checklists
·  Inpatient research-only overnight stays
·  Outpatient examination room space
·  Outpatient protocol nurse visits
·  Specialized procedure rooms
·  Metabolic meal preparation; research dietitian consultation
·  Human exercise performance measurement lab
·  Biopsies- Muscle and Liver
·  Conscious Sedation
·  Glucose monitoring, IV and Oral Glucose testing
·  Indirect Calorimetry
·  Research Drug Administration/PK sampling
·  Continuous IV Infusions
Pre-Analytical Sample Processing Laboratory
The Pre-Analytic Sample Processing Laboratory provides consistent, high-quality sample processing. By conforming to detailed 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. Services include, but are not limited to: / ·  Pre-proposal study logistics planning
·  Pre study initiation lab specimen logistics
·  Creation of detailed processing checklists
·  Laboratory technical support to conduct basic or complex processing of the highest consistency and quality, including documentation of variations and observations made during the procedures
·  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, outpatient clinics, or FHCs
·  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)
·  Training in sample processing and collection
·  Access to space
Research Coordination Services
Excellent coordination is imperative for the success of any clinical study. The CRU Clinical Research Coordinators help principal investigators with everything from IRB approval to study completion. Their responsibilities and services include, but are not limited to: / ·  Pre-proposal study logistics consultation
·  Study logistics consultation of implemented studies to improve study efficiencies, accuracies, and/or enrollment and retention
·  Consenting visits and study logistics
·  Participant recruitment assistance
·  IRB Amendments and consent revisions
·  Creation of detailed procedure checklists and study kits
·  Study recruitment, phone calls (screening & follow-up) and scheduling
·  Study visits with blood draw, questionnaires, anthropometrics, BIA, ABI, EKG
·  Community and patient education
·  ClinicalTrials.gov registration
·  ResearchMatch.org registration
CRU Facilities & Equipment
Our CRU is dedicated to efficient, reliable and high-quality study support for our PIs. To facilitate clinical and translational research procedures, the CRU offers its facilities that are indispensable for patient oriented research. Services include, but are not limited to:
Endocrinology/Gastroenterology:
·  Fat Balance Studies
·  Indirect Calorimetry
·  Oral Glucose Tolerance Test
·  Glucagon Stimulation Test
·  Cortrosyn Stimulation Test
·  Insulin Tolerance Test
·  Mixed Meal Tolerance Test
·  Glucose/Insulin Clamp Studies
·  Continuous Insulin Infusion
·  Endoscopy
·  Nutritional Assessment
Cardio-pulmonary:
·  Exercise Stress Testing - cycle ergometry or treadmill
·  EKG
·  Bronchoscopy
·  Pulmonary Function Testing
·  Plethysmography
·  Exhaled NO
·  Sleep Studies
Pediatrics:
·  Pediatric IV Access and Phlebotomy
General:
·  Pharmacokinetic Studies
·  Long-Line Blood Draws (Blood Sparing Technique)
·  Off Unit Capabilities for Blood Draws and Infusions
·  Continuous Pulse and BP Monitoring
·  CADD Pump Infusion
·  Conscious Sedation
·  Central Line Site Care
·  Peripheral Line Access and Maintenance
·  Ankle Brachial Index (ABI)
·  Bioelectrical Impedance Analysis (ABI)
·  Infusions
·  Cognitive Testing
CRU Equipment:
·  Centrifuges
·  Fume Hood
·  Laminar Hood
·  Freezers (-20°c, -80°c)
·  Refrigerator (4°c)
·  Elutriator
·  Blood Draw Capability
·  Flexible Bronchoscopy
·  Flexible Endoscopy
·  Dual Infusion Pump
·  Plethysmography
·  Indirect Calorimetry
·  Pulmonary Function Spirometry
·  Pulse Oximetry
·  Negative Inspiratory Force Meter
·  Cycle Ergometer
·  Treadmill
·  Doppler
·  Bioelectrical Impedance
·  EKG
·  Ultrasound

CRU Policy Grid Rev Effective 06/2016