The Pre Award team is responsible for the creation, review, negotiation and execution of contracts and or subcontracts related to clinical research at the University of Miami.
To ensure effective and efficient initiation of the Clinical Research project, the Principal Investigator and relevant department should conduct a feasibility review prior to submission to ORA. This feasibility review should include a financial review, consideration with respect to available technical and personnel resources and sufficient patient pool, as well as any third party required deadlines assessing whether the University of Miami can initiate the Clinical Research project within that specified deadline. To assist with the financial portion of the feasibility review, please click here for the Clinical Budget Checklist and here for the Study Budget Template.
The Clinical Trial Checklist includes all of the required documents and information needed before submitting to ORA.
Below is a NIH policy that refers to the Dissemination of NIH-Funded Clinical Trial Information.
| Clinical Research Initiation Service (CRIS) Fee is required by our institution in order to participate in clinical research. The CRIS fee is a one-time fee charged to all industry-supported studies. This is a mandatory, non-refundable, central office fee that applies to all new projects and any amended projects that were not assessed the fee originally. The CRIS fee covers expenses associated with the University’s central research administration’s review of the study materials, assessing the need for and developing coverage analysis (when applicable) to ensure research billing compliance, as well as contract and budget negotiations. |
CRIS FEE - $3,500 |
| CRIS Amendment Fee is required by our institution for each amendment to the original agreement resulting from the amendment to the Protocol and necessitating the review/revision of the initially developed coverage analysis. It is not subject to overhead. Amendment CRIS fee covers expenses of the University’s central research administration related to reviewing of revised study documents to assess the need for revision of the coverage analysis, as well as reviewing and negotiating contract and budget amendment. |
CRIS Amendent Fee - $750 |
| Initial Research Feasibility Fee (RF) is required by our institution for all industry sponsored clinical trials. The Initial RF fee is a one-time mandatory fee and is not subject to overhead. The RF fee covers expenses of the University’s research feasibility committee and administrative costs related to reviewing the study protocol, the capabilities of the study team conducting the study, and the recruitment plan, in addition to assessing the eligible study population to ensure the study is feasible and will meet enrollment targets. |
Initial Research Feasibility Fee (RF) - $250 |
| F&A for Industry Clinical Trials The University currently accepts reduced F&A rate of 36% for industry-supported clinical trials, applicable to all direct costs, with the exception of IRB fees, Feasibility Review Fee and CRIS fees. |
Below you will find links to additional information related to the initiation of a Clinical Research project.
When initiating Clinical Research at the University of Miami, you will need to also communicate and work with the following offices:
