INDUSTRY CLINICAL STUDY FINANCIAL ACCOUNT CLOSE OUT

Clinical Trial Agreements (CTAs) govern the terms of research between the Universities and set the expectations and responsibilities of the parties. Most clinical trial agreements (CTA) do not have a specified end date stated in the contract. The agreements typically state that the study will terminate when the study has been completed at the site or when the sponsor sends site closure notification in writing

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.

PROCESS

1. IRB Closure: The first step is for the department to close out the study with the IRB. Once all patients enrolled at UTHealth have completed all visits, the department should submit an IRB closure report within iRIS and to the central/commercial IRB (if applicable).

2. Departmental Financial Account Review: The PI or departmental designee responsible for financial management of the study should conduct a final review the financial account. The financial account should be reviewed to ensure:

• The sponsor has paid for all visits/activities that occurred (including hold back if applicable).
• All invoiceable items noted in the contracted budget have been invoiced to the sponsor.
• All expenses and invoices received related to the study (example MHH, Quest, Radiology, CRU etc.) have been paid.

3. Submit “Clinical Research Account Close Out Form” to CRF team: Once it has been confirmed that all payments have been received and all invoices related to the study have been paid, the department should submit a Closeout Form to the CRF Team via crf@uth.tmc.edu to ensure that the study is closed out in FMS and START.

• The form is located on SPA website under Forms & Templates: Link
• **The form requires signature of Departmental Leadership (DMO, Chair, etc) If the department is requesting a split, justification should be provided.

4. CRFA Analysis: CRFA analyzes the account expenditures and payments. CRFA processes requests within four weeks of receipt of a complete and accurate close out request form. (Depending upon volume, timing may vary slightly.)

• If expense discrepancies are noted during the CRFA analysis, the CRFA team will submit an advised split for departmental Leadership approval. If this step occurs, DMO/Chair sign off on the final amounts to be transferred to specified accounts will be required.

5. CRFA Submits Journal In FMS: Once the above steps have been completed (as applicable), CRFA will then perform the necessary journal entries to transfer the residual balance to the appropriate residual accounts for spend down.

6. Department Budgets Residual Transfer: After the journal entries have been complete, then the department can budget the transferred revenue in the residual account.

****Please note- the above process is applicable only to FMS accounts with 57001 fund codes. To closeout accounts that do not have a fund code of 57001, the PAF close out form (located here: Link )  should be completed and sent to PAF at paf@uth.tmc.edu

DEPARTMENT TASKS/RESPONSIBILITIES

• Submit IRB Closeout Report 
• Perform a review of the financial account
• Complete the “Clinical Research Account Close Out Form”
• Obtain necessary signatures on the “Clinical Research Account Close Out Form”.
• Send signed document to CRF@uth.tmc.edu
• Budget transferred revenue in the residual account.

SPA TASK/RESPONSIBILITIES

• Process account close out requests
• Perform account analysis.
• Perform necessary journal entries to transfer residual revenue to residual account(s).
• Ensure account is marked as Closed in FMS and START