After internal review of the minimum required documents, the Clinical Trial Research Process Manager (CT RPM) begins Budget Development. While there are some parts of Budget Development that may be completed by the CT RPM before the Kickoff Meeting (e.g., populating salary information and study team effort calculations), the majority of Budget Development takes place during, and possibly after, the Kickoff Meeting. During Budget Development, the CT RPM works with the study team to discuss:
• PI approval of coverage analysis
• gaps that have been identified between the internal budget and sponsor’s payment schedule,
• compliance issues needing resolution prior to finalizing the budget, and
• an action plan, developed in conjunction with the study team, to resolve any outstanding issues.
If the internal budget cannot be completed by the end of the KOM, both the study team and the CT RPM assume responsibility for outstanding portions of the budget still requiring resolution. Ultimately, the CT RPM and study team work toward understanding and documenting the estimated costs of conducting a study at Stanford, broken down into start-up, per patient amount, and invoiceable fees, while addressing all clinical research compliance issues prior to negotiating the budget with the sponsor.
Sub Category 1: Start-up Costs
Start-up costs cover any work initiated prior to enrolling the first patients. These costs include:
• IRB Initial Review Fee: The CT RPM automatically populates this fee, when applicable.
• Clinical Trial Start-up and Compliance Review Fee: The CT RPM automatically adds this fee, where applicable.
• LPCH or SHC Pharmacy Fees: The study team contacts the appropriate pharmacy to obtain these fees, if applicable.
• CTRU Fee: Study team requests CTRU Start-up fees when completing the CTRU Budget Builder, if applicable.
• 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 will be included in start-up. The study team should discuss any additional fees at the KOM between with the CT RPM.
Sub Category 2: Per Patient Amount
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 usually include both PI and Study coordinator time, but may include other study team members as well. The study team submits this information to the CT RPM via the complete Study Activation Form.
• Hospital (Technical) and Professional Fees: The Principal Investigator separates out patient care services into protocol items billable to the patient (standard of care) versus research patient care services paid for by the sponsor. The study team documents the determination by placing research services on the Research Patient Services tab of the Budget and Billing workbook and listing the standard of care services on the Routine Care Form of the Workbook . Workbooks should be filled out thoroughly prior to submitting as one of the minimum required documents. The CT RPM then adds the research patient care services to the internal budget, if applicable.
• Patient Reimbursement: The CT RPM reviews the consent form, if available, and enters patient reimbursement as part of the per patient amount. If the consent has not been provided, the CT RPM reviews this section with the study team at the KOM. Prior to the budget finalization, patient reimbursement amounts in the internal budget must match the consent form.
• 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 Builder. 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.
Sub Category 3: Invoiceable Fees
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.
Sub Category 4: Compliance Issues
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.