Budget Development

Start-up costs cover any work initiated prior to enrolling the first patients. These costs include all applicable institutional fees as determined by CT RPM such as:

• IRB Initial Review Fee
• Clinical Trial Start-up and Compliance Review Fee
• SHC CA fee 
• LPCH or SHC Pharmacy Fees - If applicable, the Study team contacts the appropriate pharmacy to obtain these fees
• CTRU Fee - If applicable, Study team requests CTRU Start-up fees when completing the CTRU Budget Builder
• Research Personnel Start-up Costs - The study team estimates effort to be spent on start-up activities by the study team. The CT RPM calculates the costs associated with the effort estimate
• Other - Sometimes other fees like advertising or training will be included in start-up. The study team should discuss any additional fees at the KOM

The per patient amount is Stanford’s estimated cost of running 1 patient through the protocol. The per patient amount includes:

• Study team Effort: The department provides the CT RPM with an estimate of the number of hours it takes for the study team to run one patient through the protocol. These effort estimates include hours per patient for both PI and Study coordinator time, and may include other study team members as well. The study team submits this information to the CT RPM via the CT PDRF.
• Hospital (Technical) and Professional Fees, as reflected in the Budgeting and Billing Workbook. The CT RPM adds the research patient care services to the internal budget, if applicable.
• Patient Stipends & Reimbursements: The CT RPM reviews the consent form, if available, and enters this cost as part of the per patient amount. If the consent has not been provided, the CT RPM discusses this cost with the study team at the KOM. Prior to the budget finalization, patient reimbursement amounts in the internal budget must match the consent form. Alternatively, if the Sponsor will process stipends and cost reimbursements with a 3rd party this is noted within the ICF and internal budget.
• LPCH or SHC Pharmacy Dispensing Fees: When the Investigational Pharmacy dispenses the investigational drug, the study team contacts the appropriate pharmacy to obtain these fees. The CT RPM adds these fees into the per patient amount.
• Clinical Translational Research Unit (CTRU) Per Patient Fee: If the study team uses the CTRU for any research patient care services, the study team completes the CTRU Budget Workbook. CTRU can only provide research services billed to the study PTA; CTRU cannot provide standard of care services. Once the study team confirms the CTRU Fees, the CT RPM adds these fees to the per patient amount.

Invoiceable fees fall into several different categories:

• Patient care services not provided to every patient per the protocol,
• Patient care deemed not billable for every patient enrolled in the study, pending particular circumstances,
• Central Office administrative fees such as IRB renewal fee, RMG amendment fee, etc., and
• Department administrative fees like monitor visit, SAE reports, close-out visits, etc.

The CT RPM discusses the Invoiceable fees in depth at the KOM because they can be difficult for the study team to identify prior to the KOM.

The CT RPM ensures compliance with Stanford policies, state and federal regulations.

• Uniform Guidance (UG): The CT RPM develops the study budget in compliance with requirements set-forth in UG. While UG addresses federal awards, Stanford applies this guidance to all sponsored projects, regardless of funding source.
• Billing Compliance: The CT RPM ensures the negotiated budget meets with Federal Medicare billing regulations. The CT RPM provides guidance in areas such as Medicare regulations (including Medicare Secondary Payer, Medicare No Legal Obligation to Pay, Medicare National Coverage Determination, Medicare Preauthorization etc.) and other billing compliance laws such as double billing.
• The CT RPM reviews the consent, sponsor payment schedule, and internal budget so all documents align and contain the same information.
• PI Training completed.
• PI Eligibility confirmed or a waiver approved prior to awarding the study.
• GCP training for everyone listed on the budget and IRB approval current.
• Hospital approvals, if needed, obtained.
• COI addressed in Stanford systems and escalated appropriately, if needed.