DISCRIPTION

Clinical studies funded by pharmaceutical and medical device companies, and are an important part of the Food and Drug Administration (FDA) approval process for new drugs and devices.  The data from these clinical studies help to ensure the safety and efficacy of the drug or device being brought to market.

Clinical Trial Agreements (CTAs) govern the terms of research between the University and the Sponsor and set the expectations and responsibilities of the parties. 

PROCESS

Clinical studies require coordination between multiple groups. The  department administrators, the study staff and billing team(s) should  meet to discuss the protocol and procedures and services provided as part of the study  A communication plan should  be created for study visit scheduling & billing, and for financial management (invoicing, and payment reconciliation).

COVERAGE ANALYSIS

The first thing that should be done is to complete the coverage analysis.  The coverage analysis is an itemized list of every procedure called for in the protocol.  This includes both effort based and patient care based procedures.  The coverage analysis details which visit each procedure will done at and whether or not it will generate a bill in the clinic billing system.  If an item generates a bill, the study team must designate whether that charge will be standard of care (SOC) or research.  All SOC items will need to have a justification provided to detail how that conclusion was made.  Adequate justifications include peer reviewed journal articles, nationally published guidelines from professional medical organizations, or national coverage determinations from the Centers for Medicare and Medicaid.  The Coverage analysis process is initiated by the department submitting the protocol to the IRB. The CRF team reviews all studies submitted to the IRB and identifies all studies that require a coverage analysis. The CRF team creates an agreement record in START (AGT record) for each coverage analysis. The department is notified once the coverage analysis has been completed.

COST ANALYSIS

After the coverage analysis has been completed, it is now time to begin working on the Cost Analysis (also referred to as the internal budget) The Coverage Analysis/Internal Budget tool (CAIB tool) is utilized to conduct a cost analysis. The goal of the cost analysis is to determine how much it will cost to conduct the study. This includes salary expenses for time and effort allotted, startup expenses, patient care expenses and additional fees that may be incurred. The CAIB tool provides a methodic approach for capturing these costs. (See “CAIB Tool Guidance Document “for additional resources) If the cost analysis is being completed by department administrative staff, they will need to meet with the study team to discuss each visit in detail and start up activities to verify the time and effort involved is captured accurately.

NEGOTIATING BUDGE WITH SPONSOR

After the cost analysis has been completed the departmental staff is now ready to negotiate the budget with sponsor. Please be sure to include additional amount to cover hidden costs such as underestimation of time and effort and or increase in costs.

DEPARTMENT TASKS/RESPONSIBILITIES

1.Study team meet with department administrative staff (budgeting and financial management) and billing staff (patient care charges) to go over protocol procedures.

2. Submit Protocol to IRB (initiates coverage analysis process)

3.Submit draft CTA to SPA vis START (See START guidance document “Clinical Trials-PD”

4. Review final Coverage Analysis. if any issues are noted, submit change request to crf@uth.tmc.edu for approval

5. Calculate the costs associated with Start Up, Per Patient procedures and effort based costs utilizing CAIB tool.

6. Negotiate with sponsor to ensure that your final budget covers all costs associated with the study.

7. Submit START Proposal Record to SPA

8. Review final contract to ensure the budget is correct.

SPA TASKS/RESPONSIBILITIES

1. Ensure a Coverage Analysis (CA) has been created for all applicable studies.

2. Ensure an Agreement record (AGT) has been created for CA in START

3. Work with the department to incorporate changes to CA if applicable

4. Negotiate legal verbiage for all CTA’s submitted to SPA via START and execute agreement with Sponsor