Industry-Sponsored Clinical Trials
The Office of Clinical Research (OCR) has developed a streamlined intake process for new non-Federally sponsored clinical research projects.
All Confidentiality Disclosure Agreements (CDA) received from sponsors/CROs must be submitted to OCR@health.usf.edu. OCR will route CDAs to USF Division of Patents and Licensing (P&L) for negotiation and execution. P&L will distribute the fully executed CDA to the site, the sponsor/CRO and copy the OCR.
As soon as the decision has been made by the PI to move forward with a new study, the PI or their designee will forward the following essential documents to the OCR Intake email at OCR@health.usf.edu
- Draft Consent Form
- Draft Budget
On OCR's receipt of these documents, the startup processes will begin simultaneously.A Project Liaison (PL) will be assigned to the study and will contact the study team to provide assistance with the budget development and negotiations, negotiate the contract language, ensure the contract payment terms meet our requirements, work directly with USF General Counsel to ensure the contract meets institutional requirements and with USF Research Integrity and Compliance to ensure the contract includes all required AAHRPP elements, and review the subject injury language in the contract and consent form for concordance. The PL will complete the Coverage Analysis and assist with the investigational device exemption submission to First Coast Service Options, our local Medicare Administrative Contractor, as necessary after IRB approval for device studies.
The study site team will prepare the IRB submission. For studies that will be submitted to a USF relied upon Commercial IRB (USF Relied Upon IRBs), there is a new process to obtain the Commercial IRB Approval to Proceed letter. Research eligible for review and approval by an independent commercial IRB must first be submitted to the USF IRB via ARC (eIRB) by submitting an external application. USF IRB administration will conduct an administrative review of the application and materials and will provide a letter of approval to proceed to the Principal Investigator. This letter of approval to proceed must be submitted to the reviewing commercial IRB along with that IRB’s required application.
During this time, the site will send to OCR@health.usf.edu any additional documents that are received from the sponsor/CRO and as requested by OCR staff.