Georgetown University Clinical Research Unit

1. Georgetown University Clinical Research Unit Shaunagh Browning RN, FNP-BC

2. Mission of the CRU Provide clinical, biostatistical and specialized research support for both industry, NIH sponsored, pilot projects and other sponsored research.

3. Resources Available Inpatient and Outpatient Beds Clinical Research Nurse Support Precise timing and management of research protocols including complex Study drug infusions, PK sampling, Chemotherapy administration, and other protocol specific clinical needs Simple and Complex Specimen Processing and Shipping

4. Resources Available Core Services Such as: Neuroimaging Bioanalytical Laboratory Biostatistical Consultation

5. The Application Process Don�t wait! If you are not sure if we can help please call. We most likely can. The application to the CRU does not have to happen after IRB approval. You can submit simultaneously. The application is on-line at http://gcrc.georgetown.edu The CRU administrative team can help if you have questions about how to complete.

6. The CRU application Complete Application Full Length Protocol Informed Consent(s) and Assets if applicable Completed IRB application (if completed at time submitting to the CRU IND where indicated E-mail to: gcrcadmin@georgetown.edu

7. 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 even for federally funded projects 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

8. CRU approval Currently protocols that are federally funded require Advisory Committee Approval Industry sponsored studies do not require this approval The approval process is going to change in the near future�visit our web site for updates

9. 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.

10. 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

11. 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