描述

由制药和医疗设备公司资助的临床研究，是食品药品监督管理局（FDA）批准新药和设备批准过程的重要组成部分。来自这些临床研究的数据有助于确保被推向市场的药物或设备的安全性和功效。

临床试验协议(CTAs) govern the terms of research between the University and赞助商和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.

成本分析

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.

与赞助商进行谈判

成本分析完成后，部门工作人员现在准备与赞助商协商预算。请确保包括额外的金额，以支付隐藏的费用，例如低估时间和精力和 /或成本增加。

DEPARTMENT TASKS/RESPONSIBILITIES

1.研究团队会见部门行政人员（budgeting and financial management) and billing staff (患者护理费用）处理协议程序。

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

3.提交草案CTA SPA vis开始(见开始guidance document “Clinical Trials-PD”

4. Review final Coverage Analysis. if any issues are noted, submit change request tocrf@uth.tmc.edufor 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.查看最终合同以确保预算正确。

SPA TASKS/RESPONSIBILITIES

1.确保为所有适用研究创建了覆盖范围分析（CA）。

2.确保已为CA创建协议记录（AGT）

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

4.协商与赞助商的开始并执行协议，就所有CTA提交给SPA的CTA的法律词