Georgetown University Clinical Research Unit

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

2. Georgetown University Clinical Research Unit Mission of the CRU • The Clinical Research Unit’s (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. Georgetown University Clinical Research Unit Objective of the CRU 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. Georgetown University Clinical Research Unit Facilities • 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. Georgetown University Clinical Research Unit ResourcesThe GU-CRU provides both Outpatient, Inpatient and Off-Site clinical research support to both Pediatric and Adult research subjects. • 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. Georgetown University Clinical Research Unit Community Visits • 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. Georgetown University Clinical Research Unit What’s New on the CRU 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 7:00am-5:30pm for blood draw only • Monday - Friday 7:00am-4:00pm if processing and/or shipping is required.

8. Georgetown University Clinical Research Unit What’s New on the CRU DXA Machine • HologicDiscovery 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. Georgetown University Clinical Research Unit What’s New on the CRU 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. Georgetown University Clinical Research Unit What’s New on the CRU 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 it’s secure and all private information is protected. • It’s free! • Please visit www.researchmatch.org to learn more about how you can join or contact Haewon Park at hp47@georgetown.edu with any questions!

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

13. Georgetown University Clinical Research Unit GHUCCTS IRB • 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. Georgetown University Clinical Research Unit CRU Patient Care Estimates • 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. Georgetown University Clinical Research Unit Requirements After Approval • 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. Georgetown University Clinical Research Unit Scheduling Appointments on the CRU • 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. Georgetown University Clinical Research Unit CRU Open House 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. Georgetown University Clinical Research Unit CRU Contacts 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