Stanford

Roles & Responsibilities — Budgeting

Set-Up Your Study

The STUDY SET-UP stage includes activities that occur after the study has been designed and developed, and before you begin to enroll patients.

This stage includes activities in areas such as:

  • contracts & grant proposals
  • IRB approval
  • research management compliance
  • study budgeting & billing
  • required registration of trial
Roles & Responsibilities — Budgeting

PI and/or Study Coordinator

  • Determines study eligibility for Medicare NCD.
  • Identifies patient care costs in the study that are routine care versus research costs to be paid by the sponsor.
  • Completes Clinical & Translational Research Planning Workbook (CTRP Workbook).
  • Determines the level of effort required for study personnel to execute a study.
  • Identifies the locations where the research related items will be performed.
  • If study qualifies under NCD, works with CT RPM to determine if any research costs can be billed to insurance.
  • Consults with hospital ancillary services experts to correctly analyze feasibility, identify protocol required procedures and to schedule study subjects with hospital specialty areas.
  • For procedures that are not included on the CTRP workbook, provides CPT codes for research related procedures.
  • May need to provide patient information for unusual or complex procedures in order to obtain billing reports.
  • Department DFA participates in approvals of unusual circumstances.
  • For device studies, prepares Medicare FI preauthorization packet for submission to Patient Financial Services.

Spectrum

  • Provides budget/billing training, advises on hospital or regulatory issues as needed.
  • Coordinates RAC review of studies with issues related to hospital billing or adverse event.
  • Tracks submission of Medicare Pre-authorization requests to Patient Financial Services (PFS).

Research Management Group (RMG)

  • Reads protocol, IRB application, consent.
  • Reviews sponsor payment schedule and contract.
  • Meets with PI/Study Coordinator to evaluate protocol, obtain budget information, and review payment terms.
  • Provides guidance on NCD determination and whether research costs can be billed to insurance.
  • Compares CTRP Workbook vs consent vs payment schedule vs protocol to ensure consistency.
  • Acquires prices from available databases or Hospital Departments.
  • Creates budget, revises as needed, and obtains PI approval.
  • Consults with OSR, IRB, Hospital, Spectrum OTC, PFS as needed.
  • Obtains Hospital approval for device studies.
  • Negotiates budget and payment terms with sponsor.
  • Obtains waivers as needed.
  • Obtains Medicare FI approval prior to completing budget.
  • Revises payment schedule to match approved and negotiated budget.
  • For PI-initiated studies, RMG prepares budget and obtains approvals prior to submission of proposal to the funding agency.
  • Revises internal budget as needed to match sponsor award.

Hospital

  • Provides technical assistance in determining appropriate codes for tests/procedures.
  • Establishes discounts for research prices.
  • Provides pricing information as needed.
  • Submits Medicare Pre-authorization requests to the Fiscal Intermediary.
Next Steps