Clinical Trial Agreements (CTAs) govern the terms of research between the University and set the expectations and responsibilities of the parties. Industry initiated clinical trials are executed for trials following a sponsor- or investigator-initiated protocol.

Generally CTAs are funded by pharmaceutical and medical device companies, and are an important part of the Food and Drug Administration (FDA) approval process. The data from CTAs help to ensure the safety and efficacy of the drug or device being brought to market.

FUNDING A CTA

In order to properly fund a Clinical Trial from an Industry sponsor it is important to understand where the costs associated with the study come from. Generally, three main sources account for the majority of expenses associated with a clinical trial:

• Faculty and Staff Time and Effort
• Administrative Fees
• Patient Medical Costs

可以根据部门和赞助商的需求和限制来以多种方式收集这三个因素的付款。根据临床试验产生的最常见的付款类型如下：

启动付款（不退还）	在招募研究对象之前，在执行合同后，将从赞助商那里获得启动付款。beplay苹果手机能用吗有时，赞助商会要求初创企业的Uthealth发票，有时他们会自动发布付款。重要的是要阅读您的合同并知道您是否需要发票以进行此付款。Uthealth要求所有启动付款都是不退还的，因为这些付款是在研究的行政审查过程中使用的时间，精力和资源来偿还Uthealth的。
每个患者付款	Once a study is up and running, some sponsors will only pay for completed patient visits. Just like the start-ups, some sponsors will pay automatically upon receiving completed CRFs and study data, while other will require UTHealth to invoice for each patient visit. Per patient payments are intended to reimburse the University for the faculty and staff’s time and effort spent attending to the study responsibilities around that patient visit. This payment also contains the necessary funds to pay the clinic and/or hospital for all of the medical services and procedures provided for research purposes.
基于里程碑的付款	基于里程碑的付款是赞助商在启动和运行后可以为研究付费的另一种方式。在这种类型的付款结构下，赞助商只有完成一定数量的工作才能支付Uthealth。这可以是在招募了特定数量的合格研究科目，项目积极工作的基于时间的里程碑或其他措施向赞助商传达的一些措施，该措施已成功完成了根据临床试验协议预期的总项目的有意义的数量。与其他付款类型类似，可以自动从赞助商中生成里程碑的付款，也可以需要发票。这些要求在合同中详细介绍。
Invoiceable payments	可传输的付款是研究地点无法获得的那些付款。如果患者经历和对研究药物的不良反应或赞助商要求的MRI，则此类付款的一个例子是赞助商要求的选修X射线检查，这可能属于护理标准，但是在授权窗口外进行第三方保险以支付该程序的。从未自动生成可开发的付款，必须通过研究团队的发票需要。

过程

在预算的发展过程中，部门管理人员，学习人员和计费团队都应满足，以讨论作为审判的一部分提供的协议，程序和服务。预算制定模板可在SPA website.

覆盖分析

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. All coverage analysis will be reviewed by the CRF team to ensure that all procedures are identified, and that justifications properly ensure that they can be billed out to third party insurance or the patient.

STUDY STARTUP

After completing the coverage analysis, the study team will then need to perform a cost analysis for the study. The cost analysis will create line items for everything being done in the study and total them into the Startup, Per Patient, and Invoiceable costs.

Start Up costs will need to be budgeted based on the requirements of the study. Key items to remember in start up are the IRB submission fees, the administrative fees which include the time and effort for the study staff to complete all the paperwork and training prior to study initiation, investigational pharmacy setup fees, advertising fees, and anything else that will need to be paid for prior to enrolling the first patient on the study. Remember that all of these will incur a 30% overhead on them, and thus you will need to account for this before submitting to the sponsor for approval.

COST ANALYSIS

In the cost analysis, all procedures being paid for by research will need to be budgeted for. For each procedure at each visit you will need to provide how much will be expensed to the project account. These values can be obtained from the charge master documents provided by the healthcare provider (typically UT Physicians, Memorial Hermann Hospital, and Harris Health). Additionally, pricing fluctuates each year for procedures, so we suggest that you increase your pricing by 5-10% to ensure that there are enough funds in the account to pay for these procedures. Remember that all charges expensed to the account will incur a 30% overhead as well, so when budgeting these values will need to be increased by 30%.

In addition to the patient care costs, effort based costs will also need to be factored in during the cost analysis. For all effort based items provided in the trial you will need to estimate the amount of time that it will take to perform. This can then be turned into a line item cost for the visit by multiplying by the hourly rate. To calculate the hourly rate of a salaried employee, take their salary and divide by 2080, the average amount of hours per year for a 40 hour work week. When calculating the hourly rate for Principal Investigator on an industry funded study, use their full salary and benefits, not just the base.

部门任务/责任

• 完整的覆盖分析使用骨架克雷亚ted by CRF and submit tocrf@uth.tmc.edufor approval.
• Calculate the costs associated with Start Up, Per Patient procedures and effort based costs.
• Negotiate with sponsor to ensure that your final budget covers all costs associated with the study.
• 将最终预算发送给CRF@uth.tmc.eduto be incorporated in the final contract.
• 审查最终合同,确保预算。柯尔ect.

水疗任务/职责

• Create the Coverage Analysis skeleton and send to department.
• 与部门合作批准覆盖范围分析。
• Provide pricing and guidance as requested by study team to assist in budget development.
• Incorporate final budget into the agreement for execution.
• 与赞助商协商并执行协议。