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Guidelines for Financial Management of Industry-Sponsored Clinical Trials

It is the responsibility of all departmental financial analysts, in consultation with the study team, to manage the financial aspects of the clinical trials. This includes AURAs, BARAs, closeouts and extensions.

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Financial Management of Clinical Trial Accounts in IBIS

Application of PI Salary Effort Expand answer

Include all PI effort on a given trial.

For federally funded flow-through studies, refer to the following policies:

PI effort will be reviewed at a minimum of quarterly and applied where appropriate, in a timely manner, in accordance with the IBBW and subject accrual or protocol activity. Effort will be charged based on prorated accrual, not based on income received. Adjustments of actual effort vs. budgeted effort may not be greater than a 25 percent change, unless there is a contractual amendment to the agreement.

Salary assignment schedules will be reviewed at a minimum of quarterly and updated to reflect appropriate effort, where applicable.

Application of Clinical Trial Staff Salaries Expand answer

A tracking mechanism will be used for staff effort on clinical trials. The information should include the following:

  • Staff name
  • Clinical trial name/budget and fund numbers
  • Time spent on respective clinical trials and/or protocol-specific events completed

Staff time will be based on billable time that generates revenue and will be applied to the study accounts on a bi-weekly basis, via the Receiving Report process. Any other staff time will be departmentally funded.

Tools for Determining SOC vs. Research-Billable Charges Expand answer

To minimize erroneous billing to third-party insurance, study tools such as the weekly visit logs and study billing grids will be utilized for clinical trials that have research-billable items that are being entered into the hospital’s billing systems.

When weekly visit logs are utilized, they will be sent to the Clinical Research Business Analyst in Patient Financial Services weekly.

The logs will contain the following information:

  • Patient name
  • OOS number from Eclipsys
  • Medical record number
  • Service codes charged to the study
  • Trial name
  • Budget/fund numbers of trials
Monitoring SOC vs. Research-Billable Charges Expand answer

Each department shall designate an individual with specific knowledge of the clinical activity performed to review the accuracy of standard of care vs. research-billable charges on each trial.

The charges listed on the monthly billing sheets sent by HMC Finance are compared with the billing grid developed during the pre-award clinical trial process. The department will also review the accuracy of the amount being billed to the clinical trial budget, per the applicable research rate. The department will provide finalized copies of the billing sheets to HMC Finance.

Clinical trial billing sheets must be returned to HMC Finance by the date noted on the monthly clinical research billing memo. Failure to return signed billing sheets to HMC Finance will result in the charges being posted as listed. At the departmental level, such sheets will be utilized to track receivables against expenses.

Subject Stipends and Travel Reimbursements Expand answer

A clinical trials staff member will initiate travel reimbursements and subject stipends, in accordance with the Informed Consent form. The financial analyst or designated administrative staff member will review the information on the research study participation payment form against the IBBW/billing grid.

Once the information is verified for the appropriate amount and distribution (stipend vs. travel), the document is approved, ensuring proper object code use.

Information regarding subject stipends, including gift cards, and subject travel reimbursement can be found via the Clinical Trials Office.

Invoicing Sponsors Process Expand answer

The financial analyst or a clinical trial staff member is responsible for invoicing sponsors as needed, in accordance with the work performed, protocol-specific events completed and/or the contractual milestones met. This responsibility is defined at the start of the study.

Be aware of any contract-specific language pertaining to the timely invoicing of charges. Whenever allowable by sponsor, emailing invoices is recommended. The Controller’s Office must be copied on every invoice that is sent to a sponsor at the time of invoicing.

Invoice and Payment Follow-Up Expand answer

The financial analyst or a clinical trials staff member is responsible for the timely follow-up of outstanding, unpaid invoices. Examples of follow-up methods include:

  • Telephone calls to sponsor
  • Email communication with sponsor
  • Dialogue with trial monitors during on-site visits

The follow-up of outstanding invoices may be determined by the payment terms of the contract. In the absence of specific payment terms in the contract, follow-up will occur at a minimum of 60-day intervals.

Study Fund Oversight and Management Expand answer

Departments must routinely review their account balances with the appropriate individual (e.g., PI, department chair, operations director) so informed decisions can be made to determine study viability.

Available reporting tools for account management include IBIS, FIT and the College of Medicine Account Tracking system.

If there are known clinical trial deficits or lack of funding at the onset of a clinical trial, the department chair is required to sign the IBBW, which identifies the deficit to authorize the use of departmental funding for the deficit. Clinical trial deficits may be handled by transferring the expenses to the departmental MGR accounts. If a departmental MGR account is not available, expenses may be transferred to endowments in which their guidelines permit such expenditures, unrestricted gift funds or general department funds with the approval of the departmental chair, upon study completion.

Account Closeouts and Extensions Expand answer

The departmental financial analyst will review the 30, 60, 90-day report with the clinical trial study team, prior to the study end date. The departmental financial analyst will confer with the study team to ensure that all study-related activity has been completed prior to final reconciliation and account closure.

If the study has ended and the account can be closed, financial analysts must ensure the following actions are completed:

  • Generation of ACE form by the Controller’s Office
  • Reconciliation of final costs
  • Verification of spending requirement per Penn State Policy RA 90 Finalization and Closure
  • Completion of sections 1, 3 and 4 of the ACE form
  • Receipt of PI signature
  • Return of completed and signed ACE form to the Controller’s Office

If the study is ongoing beyond the current end date, an account extension may be requested. For an extension, financial analysts must ensure the following actions are completed: