For 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
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 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 Central IRB (USF Relied Upon IRBs), there is a new process to obtain the Central IRB Approval to Proceed letter, and extra copies of documents are no longer required to be sent to multiple offices. When the site indicates on the OCR New Study Questionnaire that the study is for planned Central IRB submission and the four essential documents have been received, the OCR will send the email approval to USF IRB to generate the Central IRB Approval to Proceed letter. The site must be certain to list all of the study site team members on the OCR New Study Questionnaire and to indicate whether or not any of them have a financial conflict of interest (COI) to disclose for that study or outside activity with the sponsor. Faculty members with outside activity must report the activity via the Reporting Outside Activities Database (ROAD). If the PI or any of the study site team members have a financial COI with the research, the Financial Management Plan from the eCOI module must be in place prior to submission to any of the relied upon IRBs. Even if there is no COI to report, the complete list of study site team members must be on the OCR New Study Questionnaire as the list will be forwarded to the USF IRB for confirmation that HRPP education requirements have been met.
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.