Project Application and Guidelines

Thank you for your interest in the Georgetown University Medical Center (GUMC) General Clinical Research Center (GCRC). The primary goal of the clinical research centers is to provide an optimal setting for the performance of hypothesis-driven clinical research.

The NIH requires that the GCRC Advisory Committee (GAC) approve each protocol requesting support from the GCRC. The committee evaluates projects on the basis of scientific merit, need for GCRC resources, and the inclusion of women, children and minorities into the study. The GAC assigns a priority score to each protocol; resources are allocated according to that score.

The General Clinical Research Center Application and Approval Process:
Investigators who are applying for clinical research support should provide the following:

1. Completed GAC application and a proposed budget. Please email a copy to gcrcadmin@georgetown.edu and fax the signature page to 202.444.4114
2. Full-length protocol (including scientific background)
3. Informed consent form
4. Assent form for children between the ages 7-18 years (if applicable)
5. Completed IRB application (the IRB approval letter must be submitted prior to study activation)
6. Investigational new drug (IND) status documentation from the FDA

This information is required by the GCRC administration and the GAC to review the scientific merit of the project as well as to allocate funding, space and staff on the clinical research center unit or for core lab use.

Protocols that will be open to enrollment at Georgetown GCRC need full IRB review from the home institution. Questions regarding IRB requirements should be directed to the Georgetown University's IRB office (202.687.1506) or by email at irboard@georgetown.edu. The IRB review is a separate and distinct process from the GCRC Advisory Committee's review process.

The Advisory Committee meets the first Monday of each month to review protocols. Expedited approval of a protocol may be requested through the GCRC administrative office, when there is an urgent need to enroll a patient.

The GAC will give final approval for the allocation of clinical research center resources following its review of the protocol and the written satisfactory response by the investigator to all required contingencies. Once GAC approval is received, the investigator should contact the GCRC nurse manager to set up a protocol activation meeting to review study procedures with the clinical research center's staff. In addition, no study will be initiated without an approved project budget. For assistance in developing budgets please contact the GCRC Administrative Director. A copy of the final IRB approval letter and the currently validated informed consent form must be on file in the GCRC administrative office before any patient may be seen in the clinical research unit.