Guidelines for Clinical Trial Agreements

Guidelines for Clinical Trial Agreements

Guidelines for Routing Clinical Agreements through the Office of Sponsored Programs (OSP)

Note:  All clinical agreements must be sent to the Office of Sponsored Programs (OSP) for review and processing.  OSP is designated as the authorized EVMS official to negotiate and submit clinical trial agreements to sponsors.  Principal investigators should contact OSP shortly after deciding to apply to a sponsor for funding.

Clinical Research Agreements:

[Please note that this process may vary depending upon the terms/conditions of individual clinical agreements.]

  • Once contact has been made between an EVMS investigator and a pharmaceutical sponsor, a non-disclosure agreement (NDA) or confidentiality agreement (CDA) is typically generated.  These documents should be sent to OSP for review and signature by the principal investigator (PI) and the director of Sponsored Programs.

                

  • The PI can then request and review a copy of the pharmaceutical protocol.

 

  • During negotiations with the sponsor, a draft copy of the clinical research agreement, draft budget, and protocol should be sent to OSP either by the sponsor, PI, or EVMS department administrator/clinical coordinator.

 

  • Sponsored Programs will then initiate contact with the sponsor and review the terms and conditions of the clinical agreement along with the budget and protocol.  (Review and final execution of clinical agreements and associated documentation may take from one to three weeks depending upon the issues being negotiated.)

 

  • Sponsored Programs will contact the EVMS department administrator/clinical coordinator and/or PI to review the draft clinical budget and ensure that all necessary costs are included in the budget: i.e. startup costs, subject screen failures, IRB fees, overhead costs, etc. Please remember that the EVMS indirect cost rate for clinical studies is 38.10%.

 

  • Once the budget has been finalized and the terms and conditions of the agreement have been reviewed, OSP will then send revised versions of these documents back to sponsor for consideration.  At this point, it may take several additional days for EVMS and the sponsor to finalize all terms and conditions.

 

  • Sponsored Programs will now work with the department administrator/clinical coordinator to generate an internal EVMS budget based upon the clinical budget sent to the sponsor.  Once the internal budget is complete, the department will need to complete the OSP Clinical Trial Agreement Form and cost match budget form, if applicable. These forms should be attached to the EVMS budget form. The department must obtain the signature of the PI and department chair.  These forms are then forwarded to OSP.

 

  • When the clinical agreement and budget are finalized, the sponsor will forward OSP a final copy of all documentation.  OSP routes at least two copies of the agreement and budget for signature by the PI, the EVMS Director of Finance, and EVMS Health Services (if necessary).

 

  • This documentation is then forwarded to the sponsor for signature.  A final executed copy of the clinical agreement, budget, and other supporting documentation is received by Sponsored Programs.  A copy of the executed agreement is sent by OSP to the PI, along with a memo or email stating any other items that may be missing.

 

  • OSP makes certain that all internal documentation, IRB approval, and other necessary approvals have been received.  OSP pre-award services will then generate an account release for the project.

 

  • At this point, Sponsored Programs post-award services will set up the project and assign the project a grant number.  The PI can then begin charging costs to the project.  Post-award works with the PI, department administrators, and/or clinical coordinators to ensure that the project budget is in-line with expected revenue based on enrollment, reimbursable project costs are invoiced and payment is received.  Finally, post-award will also coordinate closeout of the project when complete and all funds have been received.    

 

  • OSP will send out the clinical monitoring form on a quarterly basis. This form will need to be completed and returned to OSP in a timely manner. 

 

 OSP is located in Room 132, 1st Floor of Andrews Hall. Please contact us at 757.446.6151 with any questions. For Post-Award related questions about clinical trials, please contact Renee Tynes at 757.446.6024.

 

Visit the OSP Website to obtain forms and other information related to sponsored programs:

http://www.evms.edu/office-of-sponsored-programs/office-of-sponsored-programs.html

Rev. 11/2012

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