Institutional Financial Requirements Post-IRB Approval

Once the research study receives IRB approval, additional financial tracking occurs. 

Clinical Trial Management System (CTMS)

The CTMS utilizes DDOTS CREDIT© as the software program that is used to track financial operations of clinical trials. The CTMS captures and tracks the protocol required tasks with the internal cost and sponsor reimbursement, tracks invoices and receivables, documents study subject visits, provides calendar of upcoming study visits, email notification from the study coordinator to CTMT of subject visits and invoiced tasks, and provides financial reports for the Investigator and Accounting.

The protocol, study visits and visit tasks are entered into CREDIT by the CTMT. The research site is responsible for entering the study subject into CREDIT, linking the subject to the protocol and upon completion of each visit, check off all events that occurred within the associated visit.

Financial Research Accounts

Upon a study’s initial IRB approval, the CTMT will send a Create Account Request to Grants Accounting along with the approved IRB letter and copy of the executed contract/Clinical Trial Agreement or notice of waiver of IDC. Trial related revenues and expenses should be recorded directly to the trial account in a timely manner to ensure accurate balances are available for monitoring.
On a monthly basis, CTMT will generate and submit invoices for invoiceable items and variable costs in accordance with the Clinical Trial Agreement. Upon reciept of sponsor payment or payor source, CTMT will record the payment in the CTMS, apply the payment to the appropriate procedures, submit a Research Funds Transaction Request to Accounting, complete an IT or check request to cover expenses related to the payment and apply salary costs to the appropriate account.

Monthly Tracking

Upon closure of the general ledger in Accounting, the CTMT will perform a monthly review to ensure that all institutional and study invoices have been generated and submitted for payment; all payables have been paid to the appropriate vendor; and all outstanding invoices have been paid or notices sent as appropriate to include per patient fees, variables, departmental fees and institutional fees (CTMT, Research Pharmacy and IRB).  Monthly the CTMT will send Accounting the associated salaray expense with the appropriate general ledger code so that all salary expense can be entered into Peoplesoft by Accounting.

Research Study Closeout/Residual Funds

Residual balances resulting from completed Clinical Trial Agreements/Contracts may be transferred to the Department, Sections in the Department, faculty member’s residual account(s) or distributed through the Department Faculty Income Plan and may be spent as discretionary funds in accordance with institutional/state policy as approved by the Department Chair. 

In order for residual balances to be transferred, all revenue must be billed, collected, and confirmed as unrestricted.  At the time of transfer Indirect Cost (IDC) will be applied to any residual balance using the rates in effect for the each individual contract.  Residual balances are established after CTMT reconciles all revenue and expenses for the study, all revenue earned has been credited to the applicable PeopleSoft project, and all expenses incurred to completed the project have been charged to the applicable PeopleSoft project.