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。

资助CTA

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：

• 教职员工的时间和努力
• 行政费
• 病人的医疗费用

Payment for each of these three contributing factors can be collected in a variety of ways depending on the department and sponsor’s needs and restrictions. The most common types of payments that are generated under clinical trials are as follows:

Start-up payments (non-refundable)	Start-up payments are received from the sponsor upon execution of the contract, prior to enrolling research subjects. Sometimes the sponsor will require that UTHealth invoice for start-ups and sometimes they will automatically release payment. It is important to read your contract and know whether or not you will need to invoice for this payment. UTHealth requires that all start-up payments be non-refundable, due to the fact that these payments are reimburse UTHealth for the time, effort, and resources utilized during the administrative review process of the study.
Per patient payments	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
Milestone based payments	Milestone based payments 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	可发出的付款are those which are not guaranteed to be earned by the study site. An example of this type of payment would be an elective X-Ray required by the sponsor should the patient experience and adverse reaction to the study drug, or an MRI that is required by the sponsor which would could fall within the standard of care, but was performed outside the authorized window for third party insurance to pay for the procedure. Invoiceable payments are never automatically generated and must be required via an invoice from the study team.

PROCESS

During the budgeted development process the department administrators, the study staff and billing team(s) should all meet to discuss the protocol and procedures and services provided as part of the trial. A template for budget development is available on the水疗网站。

COVERAGE ANALYSIS

首先要做的就是完成覆盖范围分析。覆盖范围分析是协议中要求的每个过程的逐项列表。这包括基于努力和基于患者护理的程序。访问每个程序的覆盖范围分析详细信息以及是否会在诊所计费系统中产生帐单。如果项目产生账单，则研究团队必须指定该指控是护理标准（SOC）还是研究。beplay苹果手机能用吗所有SOC项目都需要提供一个理由来详细说明如何得出结论。足够的理由包括同行评审的期刊文章，专业医疗机构的全国性发布准则或来自Medicare和Medicaid中心的国家保险范围。CRF团队将审查所有覆盖范围分析，以确保确定所有程序，并正确确保可以向第三方保险或患者账单。

研究启动

完成覆盖范围分析后，研究团队将需要对研究进行成本分析。成本分析将为研究中所做的所有工作创建订单项，并将其总成启动，每个患者和不可投票成本。

启动成本将需要根据研究要求进行预算。启动时要记住的关键项目是IRB提交费，管理费用，其中包括研究人员在研究启动之前完成所有文书工作和培训的时间和精力在入学第一位患者研究之前，需要支付支付费用。请记住，所有这些都会在它们上蒙受30％的开销，因此您需要在提交赞助商批准之前对此进行解释。

成本分析

在成本分析中，需要为研究支付的所有程序需要预算。beplay苹果手机能用吗对于每次访问中的每个过程，您都需要提供将支出多少到项目帐户。这些价值可以从医疗保健提供者提供的收费主文件（通常为UT医师，纪念赫尔曼医院和哈里斯健康）中获得。此外，定价每年都会有所波动，因此我们建议您将定价提高5-10％，以确保帐户中有足够的资金来支付这些程序。请记住，支付给帐户的所有费用也将产生30％的开销，因此预算时，这些价值将需要增加30％。

除了患者护理费用外，在成本分析期间还需要考虑基于努力的成本。对于试验中提供的所有基于努力的项目，您将需要估计执行所需的时间。然后，这可以通过乘以小时费率来将其变成访问的订单成本。要计算有薪雇员的小时费率，请在2080年之前进行薪水和分歧，这是40小时工作周的平均小时数。在计算一项行业资助研究的首席研究人员的小时费率时，请使用其全部薪水和福利，而不仅仅是基地。

DEPARTMENT TASKS/RESPONSIBILITIES

• 使用CRF创建的骨架进行完整的覆盖范围分析，并提交给crf@uth.tmc.edu需要批准。
• 计算与启动相关的成本，每个患者程序和基于努力的成本。
• 与赞助商进行谈判，以确保您的最终预算涵盖与研究相关的所有费用。
• Send final budget tocrf@uth.tmc.edu被合并到最终合同中。
• Review final contract to ensure the budget is correct.

SPA TASKS/RESPONSIBILITIES

• 创建覆盖范围分析骨架并发送到部门。
• Work with department to approve coverage analysis.
• 根据研究团队的要求提供定价和指导，以协助预算制定。
• 将最终预算纳入执行协议中。
• Negotiate and execute agreement with Sponsor.