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

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

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

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)

NEGOTIATING BUDGET 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.将协议提交给IRB

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

3. Review final Coverage Analysis. if any issues are noted, submit change request tocrf@uth.tmc.edufor approval

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. Submit START Proposal Record to SPA

7. 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