INDUSTRY CLINICAL STUDY BUDGETS
Clinical Trial Agreements (CTAs) govern the terms of research between the Universities and set the expectations and responsibilities of the parties. Industry initiated clinical trials are executed for trials following a sponsor- or investigator-initiated protocol.
Generally CTAs are funded by pharmaceutical and medical device companies, and are an important part of the Food and Drug Administration (FDA) approval process. The data from CTAs help to ensure the safety and efficacy of the drug or device being brought to market.
Because most industry initiated clinical trials are fixed price awards, the University will be paid for services rendered, regardless of how much of the funds are expensed. The terms of the contract allow for the residual balances in these accounts to vest with the University. In order to properly account for expenditures associated with the clinical trial, the FMS account associated with a clinical study must be closed out once the research is complete at the University.
Clinical Trial Account Closeout begins once the IRB Closeout Report has been submitted in iRIS. Each month the CRFA team reviews the submitted closeout reports in iRIS for funded studies. If a funded study has been closed, the FMS account is updated to reflect the date that the study ended at the University. CRFA then changes the active dates on the account to allow the study team one year to receive final payment from the sponsor and to pay any outstanding invoices which may still be pending.
After the one year period following the close of the study at the University, the CRFA team will then conduct a complete account analysis. This analysis will take into consideration the number of study subjects enrolled at the University, the revenues received from the sponsor, the expenses applied to the account. The CRFA team will take note of the amount of effort expensed to the account as well as the patient care costs which should have be incurred during the study. If there is a discrepancies between the internal budget that was submitted with the project and the expenses posted to the account, then the CRFA team will suggest an amount that the department should recover from the remaining residual balance.
The analysis and report generated by the CRFA team is then submitted to the Director of Management Operations, or other departmental leadership where appropriate for review and approval. If the departmental leadership approves of the suggested split, he or she will sign off on the approval and have the Principal Investigator sign off on the approval as well.
At this time, the departmental leadership can suggest an alternative split from the CRFA team’s suggested split. If this occurs, the departmental leadership will need to provide a justification for the alternative split and obtain the signatures of both the Chair and the Dean of the department.
Once the CRFA team receives the signed approvals they will then perform the necessary journal entries to transfer the residual balance to the appropriate residual accounts for spend down. After the journal entries have been complete, then the department can budget the transferred revenue in the residual account.
- Submit IRB Closeout Report
- Review Account Analysis from CRFA team
- Obtain necessary signatures on the Clinical Trial Closeout Summary and Approval Form.
- Send signed document to CRF@uth.tmc.edu
- Budget transferred revenue in the residual account.
- Perform monthly check of closed studies in iRIS.
- Mark accounts for closeout one year after their date of closure in iRIS.
- Ensure no outstanding revenues or expenses are pending on the account.
- Perform account analysis and suggest residual revenue split.
- Send completed Clinical Trial Closeout Summary and Approval From for signature to department management.
- Perform necessary journal entries to transfer residual revenue to residual account(s).