Budgeting & Financial Management

YCCI assists investigators with a variety of budget services. For industry sponsored trials, we review, modify and negotiate these budgets on your behalf to ensure your costs are covered by the sponsor and your research efforts are financially sustainable. We also provide budget drafting services for investigator-initiated trials (IITs) and grants.

Once a budget is final, we provide the internal budget which documents internal financial distribution of study funds for accounts receivable management.

PALM’s research budget development unit assists investigators with developing budgets and securing funding for research studies.

• Construction and negotiation of budgets for recovery of the true cost of studies.
• Coordination of the processes between sponsors and the Office of Sponsored Projects (OSP) in support of contract language development, negotiation of the specific obligations of the parties, and other issues.
• We will work with ancillary departments that may need to include costs in the budgets, such as Diagnostic Imaging, Ophthalmology, PET center, etc.
• We will work to justify and receive sponsor approval for required costs.
• We coordinate with OSP to ensure that the budget and payment terms in the final contract are accurate and congruent.
• We collaborate with Regulatory (YCCI or department) to include patient stipends and reimbursement information as needed.
• Consultation services for junior investigators looking to obtain funding.
• Review of clinical research fee schedule

• Once you have been selected as a site and have the required study documents, submit a YCCI Service Request to the PALM team
• The PALM Activation team completes the Qualifying Clinical Trial (QCT) analysis & Coverage Analysis
• The PALM budget team completes a comprehensive review of the protocol and accompanying documents to draft an initial budget
• The budget will be provided to the PI & study team via email within 3-4 weeks of our team receiving all required documents via a YCCI Service Request
• Our team will keep you apprised on the progress of the negotiations and will follow-up if there are any concerns or if feedback is required.
• Once the budget is finalized, a final congruency review is required to ensure that the budget, clinical trial agreement (CTA) and consent form(s) are aligned.

Industry Sponsored

• YCCI will draft and negotiate Industry sponsored budgets for all departments requesting assistance through our YCCI Service Request and will include all required USP fees.

IIT

• YCCI will assist investigators to draft budgets for their IITs & provide negotiation services as needed.
• At a minimum, an IIT will need a QCT/MCA, a calendar & financial console built into OnCore (if participants are being enrolled, YCCI Research Space is being used (e.g., CSRU, HRU) and/or), and all applicable fees will be billed to your department (USP fees).

Federally Funded Research

• YCCI will assist investigators with drafting budgets for clinical trials receiving federal funding.
• At a minimum, a federally funded trial will need a QCT/MCA, a calendar & financial console built into OnCore (if participants are being enrolled or stipends are being provided via US Bank) link, and all applicable fees will be billed to your department (USP fees).

Grants

• Please contact the YSM Pre-Award Team (YPAT) office for these budgets.

The YCCI Financial Management team manages industry sponsored invoicing, payments and follow-up on behalf of Yale Medicine clinical departments. The team does monthly sponsor invoicing and reconciles clinical trial industry sponsored revenue in OnCore. Monthly dashboards are distributed to departments with the total invoiced, paid and outstanding, by trial and PI.

The YCCI Financial Management team manages internal billing for research related services on behalf of Yale Medicine clinical departments. A monthly automated report is sent to departments and YCCI with research related services provided by a division of Yale Medicine to clinical trial patients, which is used to do internal billing between departments for research related services. YCCI will process the billing in WorkDay and monthly dashboards are distributed with the payments collected.

YCCI Service Request