DISCRIPTION

临床试验协议（CTA）管理大学之间的研究条款，并设定当事方的期望和责任。beplay苹果手机能用吗行业发起的临床试验将在赞助商或研究者发起的方案后进行试验。

通常，CTA由制药和医疗设备公司资助，是食品药品监督管理局（FDA）批准过程的重要组成部分。来自CTA的数据有助于确保将被带入市场的药物或设备的安全性和功效。

为了适当地资助行业赞助商的临床试验，重要的是要了解与研究相关的成本来自何处。通常，三个主要来源解释了与临床试验相关的大多数费用：

1. Faculty and Staff Time and Effort

2. Administrative Fees

3.病人的医疗费用

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	一旦研究开始并进行了，一些赞助商只会支付完整的患者就诊。就像初创企业一样，一些赞助商将在收到完整的CRF和学习数据后自动付款，而其他赞助商则需要Uthealth才能为每次患者访问。每个患者的付款旨在偿还大学，以偿还教职员工的时间和精力，以便围绕该患者就诊的研究责任。这笔付款还包含为研究目的提供的所有医疗服务和程序支付诊所和/或医院的必要资金。beplay苹果手机能用吗
基于里程碑的付款	基于里程碑的付款are another way that sponsors can pay for a study after it is up and running. Under this type of payment structure, the sponsor will only pay UTHealth once it completes a certain amount of work. This can be after enrolling specific number of eligible study subjects, time based milestones of active work on the project, or some other measure which conveys to the sponsor that the University has successfully completed a meaningful amount of the total project contemplated under the Clinical Trial Agreement. Similar to the other payment types, Milestone based payments can be generated automatically from the sponsor or they can require an invoice. These requirements are detailed in the contract.
可发出的付款	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。预算制定模板可在水疗网站。

覆盖分析

应该做的第一件事是完成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

覆盖范围分析完成后，现在是时候开始进行成本分析（也称为内部预算）进行覆盖范围分析/内部预算工具（CAIB工具）进行成本分析。成本分析的目的是确定进行研究的成本。这包括分配时间和精力的工资费用，启动费用，患者护理费用以及可能产生的额外费用。CAIB工具提供了一种捕获这些成本的方法方法。（有关其他资源，请参见“ CAIB工具指南”）

与赞助商谈判预算

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.

部门任务/责任

1.将协议提交给IRB

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

3.审查最终覆盖范围分析。如果注意到任何问题，请将更改请求提交给crf@uth.tmc.edu需要批准

4.计算使用CAIB工具的启动，每个患者程序和基于努力的成本相关的成本。

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

6.将开始提案记录提交给水疗中心

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

水疗任务/职责

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

2.确保已为CA创建协议记录（AGT）

3.与部门合作，将更改合并为CA（如果适用）

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