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Procedures / How To’s

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No - This person should be charged to the FMLA Detail Account. Contact your Grant Accountant if an adjustment has to be made.

 

The program has 90 days after the grant end date to post expenses that occurred within the grant budget period.

 

If the protocol is a corporate-sponsored clinical trial and the PI received a CDA from the corporate sponsor, The CDA should be forwarded to the Contract Attorney in the Clinical Trial Office for processing. If the protocol is PI initiated and the PI is seeking funding from an outside sponsor, the PI should contact the Contract Attorney to discuss options.

 

The first step is to complete an MCA/VelosCT Determination Checklist. The questions on the checklist will allow the Clinical Trial Office (CTO) to complete an initial assessment of what type of study or trial is being contemplated and if the participants and study activities will need to be captured in our Clinical Trial Management System – VelosCT.

The CTO will provide a response to the MCA/VelosCT Determination Checklist and request that you set up your study/trial in VelosCT for management of the contract negotiation. Once the draft, or final, protocol, draft Clinical Trial Agreement (CTA), draft budget and draft ICF are uploaded, and study summary and more study details are completed, then a Study Initiation eForm should be completed. This will trigger an email notification to the CTO Inbox, and the CTO will begin the process of reviewing the documents, beginning the coverage analysis and initiating the contract negotiation.

 What is the process of getting a clinical trial agreement executed?

The staff of the CTO will efficiently process the Medicare coverage analysis, budget negotiation and negotiation of the terms and conditions of the agreement. Once both parties agree, site and sponsor, the agreement can be signed and fully executed.

 

Budget revision procedures are dependent on funder regulations. Most funders require revision requests in writing that often need the current budget, proposed changes, and revised budget as well as a written justification to support necessity. Programs can work with their Research Finance Analyst to outline funder requirements and develop the budget revision. If the funder does not require formal documentation in order to revise budgets, a copy of the revised budget can be forwarded to Research Finance to input changes.

 

The Principal Investigator writes a letter requesting a no-cost extension to Alexandria Hui, Associate Director of Research Finance. The letter should contain the Federal Grant Number, time of requested no-cost extension (usually is one year), and explanation as to why the extension is needed. Reference to dollars should not be listed. The no-cost extension is approved here at the institutional level and faxed to NIH, where approval is automatic and a revised NOGA is generated.

 

 

No - One ESF must be used per person. Include ALL of the activity numbers on this one form. The basic rule to remember is that the ESF must equal the 3454-8 code on the BU turnaround form.

 

Yes - you must fill out the Employee Services Form, write the termination date in the appropriate box and forward onto your Research Finance Analyst.

 

If a person is shared amongst several administrators, the person who handles the turnaround should handle the ESF as well. If you have a grant that the individual will be working on, forward that information to the person who handles the turnaround so that they can update the ESF and forward to Research Finance for signature.

 

If the order is related to an independent contractor/consultant/subcontract, a fully executed contract is needed. If the order is with a vendor who will be performing a service (maintenance, electrical work, extermination,etc), documentation is required for backup. When the order is for a vendor that will provide a varied amount of supplies, a contract or other backup is NOT required. For products/services of less that $1000, no quotes are required. For $1001 to $4999, 2 quotes are required. For $5000 and above, 3 quotes are required.

 

Tips: Make sure Activity Number matches Accounting Unit and Account Category matches Detail Account. Make sure you have the correct Company box checked off ( BMC-100). The Requester cannot be the authorizing signature. Make sure appropriate Level Authority has signed for the amount being requested (see FAQ #4). Original invoices only for attached documentation. Past Due charges may not be applied to current invoices.

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