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Georgetown University Clinical Research Unit

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Georgetown University Clinical Research Unit Georgetown University Clinical Research Unit 7 East, Main Bldg Hospital Mission of the CRU The Clinical Research Unit s ... – PowerPoint PPT presentation

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Title: Georgetown University Clinical Research Unit


1
Georgetown University Clinical Research Unit
Georgetown University Clinical Research Unit
  • 7 East, Main Bldg Hospital

2
Mission of the CRU
Georgetown University Clinical Research Unit
  • The Clinical Research Units (CRU) mission is to
    sustain specialized institutional resources in
    which clinical investigators can observe and
    study human physiology as well as study and treat
    disease with innovative approaches. Provide
    clinical, biostatistical and specialized research
    support for both industry, NIH sponsored, pilot
    projects and other sponsored research.

3
Objective of the CRU
Georgetown University Clinical Research Unit
  • The objective of the GU-CRU program is to make
    available to medical scientists the resources
    that are necessary for the conduct of clinical
    research.

4
Facilities
Georgetown University Clinical Research Unit
  • Located on the 7th Floor of the Main Bldg of
    Medstar GUH
  • 5 Outpatient / Inpatient private rooms
  • 1 Cognitive testing room with video monitoring
  • 2 Infusion rooms with 2 chairs in each room
  • 2 Exercise testing and physiology rooms
  • 1 Phlebotomy room

5
ResourcesThe GU-CRU provides both Outpatient,
Inpatient and Off-Site clinical research support
to both Pediatric and Adult research subjects.
Georgetown University Clinical Research Unit
  • Exercise Stress Testing
  • Pulse Wave Analysis
  • Chemotherapy Administration
  • Complex Pharmacokinetic Sampling and Collection
  • Complex Sample Processing
  • Expert IV / Phlebotomy Services
  • Insulin Clamp Studies
  • Diabetes Education
  • Vaccination
  • Telemetry
  • Cognitive Testing
  • Complex Medication Administration with Monitoring
  • 6-Minute Walk Testing
  • Metabolic Cart and Pulmonary Function Testing

6
Community Visits
Georgetown University Clinical Research Unit
  • The CRU can conduct community visits in certain
    situations.
  • Specific population groups that need
    questionnaires, bloods or other low risk
    procedures
  • Attending a clinic where a known number of
    participants will be
  • Collecting data in other parts of the campus or
    hospital where certain procedures take place

7
Whats New on the CRU
Georgetown University Clinical Research Unit
  • Research Phlebotomy Room
  • No appointment is necessary
  • subjects can walk-in with orders for both
    research bloods and standard of care labs.
    Standard of care labs still require hospital
    registration.
  • Hours of operation are as follows
  • Monday - Friday 700am-530pm for blood draw only
  • Monday - Friday 700am-400pm if processing
    and/or shipping is required.

8
Whats New on the CRU
Georgetown University Clinical Research Unit
  • DXA Machine
  • Hologic Discovery QDR DXA Scanner
  • Two staff certified to conduct the scans.
  • Can complete hip, spine, forearm and whole body
    studies.
  • Scheduling for a scan is done through the usual
    process to request research services on the CRU.

9
Whats New on the CRU
Georgetown University Clinical Research Unit
  • All New CRU Website
  • http//cru.gumc.georgetown.edu/
  • Find Resources
  • what our clinical research staff can provide for
    your study
  • information on how to apply for our support
  • downloadable forms and documents
  • directions to the unit that you can provide to
    your patients
  • biographies on each of our CRU staff
  • Quick links
  • CTO
  • IRB
  • GHUCCTS.

10
Whats New on the CRU
Georgetown University Clinical Research Unit
  • ResearchMatch
  • A national web-based volunteer registry for
    potential research participants.
  • ResearchMatch brings together researchers and
    willing volunteers who want to be a part of
    ethical scientific research.
  • You can register as a volunteer, a researcher, or
    both! It takes 5-10 minutes to register and its
    secure and all private information is protected.
  • Its free!
  • Please visit www.researchmatch.org to learn more
    about how you can join or contact Haewon Park at
    hp47_at_georgetown.edu with any questions!

11
CRU approval
Georgetown University Clinical Research Unit
  • All CRU request for resources require Review by
    the CRU Scientific Evaluation and Prioritization
    Committee (SEPCOM)
  • Studies that are specimen processing only or
    focus groups also need to apply but are eligible
    for administrative approval.

12
The Application Process
Georgetown University Clinical Research Unit
  • The application is on-line at http//cru.gumc.geor
    getown.edu/
  • The CRU administrative team can help if you have
    questions about how to complete.

13
GHUCCTS IRB
Georgetown University Clinical Research Unit
  • GHUCCTS made available a new IRB committee to
    serve the investigators for GHUCCTS studies.
  • Submission is through ERIC.
  • The SEPCOM and GHUCCTS IRB are working to
    streamline the reviews and approval process.
  • Please stay tuned for more information

14
CRU Patient Care Estimates
Georgetown University Clinical Research Unit
  • The CRU does charge for its services
  • Cost depends on funding sources and scientific
    merit of the protocol
  • Cost sharing is encouraged
  • The CTO works closely with the CRU to negotiate
    with the sponsor to include the CRU cost into the
    overall study budget
  • Do not assume that the CRU costs will not be
    covered
  • Do not wait until the study budget is negotiated
    to include and/or request CRU estimates

15
Requirements After Approval
Georgetown University Clinical Research Unit
  • Schedule an initiation meeting with the CRU staff
  • Done by contacting the Nurse Manager
  • CRU will provide protocol orders and source
    documentation for CRU activities performed for PI
    signature
  • Keep the CRU informed of all IRB actions, such as
    changes to the protocol and/or informed consent
  • The IRB is working with the CRU to provide
    updates automatically.

16
Scheduling Appointments on the CRU
Georgetown University Clinical Research Unit
  • Complete the appointment request form that is on
    our website for all CRU approved and initiated
    protocols
  • Form contains minimal information needed to
    schedule
  • Fax to 202-444-1505
  • If the request is for services the same week,
    please call 202-444-0796 to confirm availability
  • CTO registration is separate from the CRU
    appointment request

17
CRU Open House
Georgetown University Clinical Research Unit
  • We would like to thank you for all your support
    throughout 2012 and invite you to our Open House
    for some treats.
  • Tuesday January 29th
  • 3pm-5pm
  • CRU 7th Floor, Main Building
  • Chance to win Door Prizes for those that attend!

18
CRU Contacts
Georgetown University Clinical Research Unit
  • Administrative Director
  • Haewon Park 202-444-2793
  • Administrative Assistant
  • Katie Bond 202-444-0799
  • Nurse Manager
  • Shaunagh Browning 202-444-2639
  • Clinical Research Unit 202-444-0796
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