Pre-award Clinicals Tracking System
GU-Pass is used for submission, review and negotiation of industry-sponsored clinical trial agreements. Departmental personnel complete the GUMC electronic transmittal form and upload the clinical trial protocol, budget and contract to initiate the process.
Federal clinical trial proposals and agreements with pass-through academic institutions for GUMC participation in clinical studies are prepared by RDS and routed in GU-Pass as sponsored research proposals.
Note: A clinical trial agreement cannot be fully executed by OSR until an approved clinical trial budget is negotiated with the sponsor by CROO (BGRO) or CRMO (LCCC). A GMS spending account cannot be created until evidence of IRB approval is received and an internal budget is provided to manage the spending account.
The Office of Regulatory Affairs (ORA) has established eRIC (Electronic Research and Information Compliance) for submission and approval of clinical trial protocols. Contact the Institutional Review Board (IRB) for additional details.
Note: Investigators are encouraged to seek IRB approval as early in the process as possible. OSR will not establish a spending account, which is required to begin enrollment, prior to receiving notification of IRB approval.
All clinical trials either supported by federal funds or subject to FDA regulation must be registered in the National Library of Medicine’s central Protocol Registration System, known as ClinicalTrials.gov. The entity responsible for registering the clinical trial, the “Responsible Party,” is either (1) the sponsor of the clinical trial, or (2) the PI, if so designated by a sponsor, grantee, contractor or awardee. Georgetown University has established a central ClinicalTrials.gov registration and certification process. Please contact the Georgetown University Protocol Registration System (PRS) Administrator, Patricia Mazar by email to register a trial. Once registration is completed, a signed certificate will be sent to the PI and to the Office of Sponsored Research by the PRS administrator.