Institutional Financial Requirements Pre-IRB Approval

Institutional Cost Budget (ICB)

The ICB is the budget created by CTMT to determine the cost of a research study to the institution.  The ICB considers the cost of salaries, fringe benefits, and all costs related to the conduct of the study.  The ICB will be utilized to verify that the Reimbursement Budget (RB) covers the cost for conducting the research. Information provided as to the time it takes to complete a study task and the person completing it (Principal Investigatory or Study staff) will determine the internal cost to be applied to the study. The fee schedule for salary and benefits for the PI and the study staff is set by the institution and will be applied according to institutional guidelines.

Cost Analysis (CA)

The purpose of a CA created by CTMT is to identify Medicare Qualifying Trials, to identify costs to the institution for conducting the research, to provide documentation of specific details for services and procedures from the provider of services in collaboration with LSU Health Shreveport in performing clinical research and to identify and document the funding source for all research procedures.  This internal document details the services, procedures, use of the research pharmacy, use of equipment, procedures to be billed to insurance and professional services needed, if any, and the associated costs. 

UH Billing Staff and/or Professional Billing Service will utilize Charge tickets or reports generated by the CTMT for all research related procedures paid for by research in coordination with EPIC to maintain accurate billing for all research related services to the appropriate department. Each time a research subject undergoes a research-related visit where study services are paid for by research a “Charge Ticket for Inpatient or Outpatient Services” on the HRPP website must be completed on-line by the site and submitted by the close of business on the day of the visit.

The HRPP Enrollment Registration log should be completed for all subjects enrolled in Grant-funded studies. This allows for the prompt identification of all subjects involved in research on the LSU/UH campus. This also allows for the notification of previous or completed subjects in the event of significant new findings.

Reimbursement Budget (RB)

The RB is the negotiated budget between the institution and the sponsor/CRO that outlines the negotiated payment terms, per patient reimbursement, variable study and institutional fees. The research site uses the sponsor supplied RB to prepare a line item budget that covers the cost to the institution, is in line with fair market value and acceptable industry standards.  The CA and ICB are both utilized in the formulation of the RB.  The research site will also include their Research Site Administrative fees.  CTMT is responsible for including the institutional fees in the budget and the negotiation of the budget with the sponsor. 

Fees

Institutional fees applied to industry sponsored clinical trials –               

Research Site Administrative fees

Each research site has administrative fees for conducting and supporting the study that may include but are not limited to study start-up, study storage, preparation and submission of documents to the IRB, study subject re-consenting, etc. all of which incur IDC. 

Please refer to our Guide to Completing the Cost Analysis & Budget.