|
Clinical Research At Georgetown Welcome
Georgetown University Medical Center is committed to advancing medical knowledge through clinical research. Investigators at Georgetown are currently conducting over 1050 research projects, including clinical trials aimed at investigating the safety and effectiveness of new medical therapies and devices. In addition, Georgetown University Hospital is part of the MedStar Health System comprising seven hospitals in the Baltimore and Washington areas. As a result, our investigators have the unique ability to utilize a greatly expanded set of patient populations for possible enrollment into clinical trials.
Investigator Locator Services
The Clinical Trials Office at Georgetown University can help you identify qualified Georgetown investigators with the research experience and expertise necessary to help you in the conduct of your clinical trial. For Geogetown Areas of Research Expertise information please contact Tony L Hursey, MPH, Director, Clinical Trials Office.
Other Services Provided by the Clinical Trials Office
The Clinical Trials Office is dedicated to assisting you in placing and conducting your clinical trial at Georgetown University Medical Center. A partial list of our services includes:
- Study budget development and negotiation
- Liaison between investigator, sponsor, and clinical departments needed by the Georgetown investigator to conduct your clinical trial (ancillary services, special research units)
- Provision of research nurses for Georgetown investigators in need of trained support staff.
- Sponsor invoicing on behalf of the investigator
- Recipient of sponsor payments to the investigator
- Tracking of trial enrollments
Institutional Review Board
Georgetown currently has four biomedical research Institutional Review Boards (IRB) for the review of protocols involving human subjects. One of these IRB's is devoted to the review of oncology research. Please see their website for office contact information and submission requirements and deadlines.
Confidentiality Disclosure Agreements (CDA)
Please note that while CDA's can and should be sent to the PI, Georgetown University is the signature authority for all such agreements. As such, CDA's will ultimately be reviewed, negotiated, and signed by a University representative. Please contact Tony Hursey at 202-687-6408 or by email at tlh3@georgetown.edu with any questions or concerns about this process.
Clinical Trial Agreements
The Clinical Trials Office facilitates negotiation of budgets which are part of the clinical trial agreement (CTA) and can provide up-to-date research pricing information for all clinical trials. Review and approval of the clinical trial agreement is handled by The Office of Sponsored Research (OSR) which serves as the Medical Center's official administrative liaison between you and the investigator. All correspondence relating to the CTA for your study should be sent directly to OSR.
Clinical Trial Budgets
The Clinical Trials Office (CTO) is responsible for negotiation of budgets, payment schedules, and payment terms which are part of any clinical trial agreement (CTA). In this capacity we work with the OSR to help ensure timely execution of CTA's.
Clinical Trial Agreements
Review and approval of the clinical trial agreement is handled by The Office of Sponsored Research (OSR) which serves as the Medical Center's official administrative liaison between you and the investigator. All correspondence relating to the CTA for your study should be sent directly to OSR.
Research Pharmacy
It is the policy of Georgetown University that any sponsor supplied study drug be stored, handled, and dispensed by our Research Pharmacy. This fully staffed pharmacy is equipped to handle all your study drug storage, randomization, preparation, and dispensation needs. Please contact the unit director Oladapo Kolawole at 202-444-7755 for information regarding research pharmacy capabilities, and to arrange for any necessary study initiation visits.
|
