Sponsors

Georgetown University Medical Center is committed to advancing medical knowledge through clinical research. Investigators at Georgetown are currently conducting over 800 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 Research Operations 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.

Please contact CROO for assistance at: gucto@georgetown.edu.

Key Services Provided by the Clinical Research Operations Office

The CROO 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 you and clinical departments needed by the Georgetown investigator to initiate your clinical trial (ancillary services, special research units)
Provision of study coordinators for Georgetown investigators in need of trained support staff.
Sponsor invoicing and payment processing
Local recruitment support and advertising

Trial Start-Up Procedures at Georgetown

Please contact our office for assistance with trial start-up procedures at gucto@georgetown.edu. Please see the information below regarding the key steps in initiating a trial at Georgetown.

Institutional Review Board (IRB)

Georgetown currently has five biomedical research Institutional Review Boards for the review of protocols involving human subjects. One of these IRB’s is devoted to the review of oncology research. Please see the Institutional Review Board’s website for office contact information, submission requirements, and deadlines.

Non-disclosure/Confidential Disclosure Agreement (NDA/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 Sharon Pula, M.S., J.D., Associate Senior Director for Licensing and Intellectual Property, for assistance with this process.

Clinical Trial Budgets

The Clinical Research Operations Office (CROO) is responsible for the 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 are 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. Contact information for the OSR can be found on the OSR website.

Research Pharmacy

It is the policy of Georgetown University that any sponsor-supplied study drug is 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 Research Pharmacy at 202-444-3771 for information regarding research pharmacy capabilities, and to arrange for any necessary study initiation visits.