临床试验协议（CTA）是Uthealth与行业赞助商（通常是制药公司或设备公司）之间的协议，以进行协议为临床研究书面并提供by the industry sponsor.

*注:如果协议是关于协议的车手itten by UTHealth Faculty, or written as a collaboration between a UTHealth Faculty member and an Industry Sponsor, aSponsored Research Agreementis required. See临床试验开始想要查询更多的信息。

PROCESS

If an UTHealth physician/PI is approached by an industry sponsor to participate in a study, the PI and department administrator should perform a feasibility assessment to determine if it is financially and operationally feasible to participate in the clinical study.

如果已经确定,π/部门would like to participate, the PI or designee should submit the contract to negotiate the legal terms of the agreement.

提案开发（PD）模块与协议（AGT）模块一起使用，将临床试验协议提交给水疗中心进行处理。每项临床试验协议必须具有一开始的提案记录和协议记录。（这些记录一开始就链接了。）

• 协议模块用于：将协议本身提交给水疗中心，以审查和跟踪法律条款谈判的状态。

• 该提案模块用于：将项目信息提交给水疗中心，以进行项目和预算审查和批准，监管部门批准以及设立的财务帐户。

*看 ”Contract/Coverage Analysis/Proposal Record Workflow Document”在“工具和资源/”形式和模板下的“临床研究融资”部分中的“工具和资源”形式和模板下的视觉概述。beplay苹果手机能用吗

DEPARTMENT TASKS/RESPONSIBILITIES

1.进行可行性评估

2. Submit new START Agreement record to SPA. Submit the contract via START by creating a New Agreement record. (Select type “Clinical Trial Agreement”)See START guidance document “Clinical Trials-PD

• Complete Agreement Information Form
• Upload a copy of the draft agreement provided by sponsor
• 上传协议的副本

3. Submit protocol to IRB

• 这启动了在水疗中心的覆盖范围分析构建过程。

4. Submit a new Proposal Development (PD) Record to SPA for budget review and approvalafterthe following have been completed:

• Billing Coverage analysis has been completed (SPA staff or START will send notification once completed CA is uploaded into START)
• Internal budget has been completed (请参阅工具和形成临床研究融资下的CAIB工具指导文件beplay苹果手机能用吗)
• Budget negotiations with Sponsor have been completed by the PI/Study team.

5.上传所需文件。PD记录必须准确地完成，并将数据输入到所有选项卡中。以下文档必须在“附件”选项卡下上传：

• Copy of Final budget with sponsor
• 带有完整内部预算信息的CAIB工具的副本
• Copy of IRB approval(s)
• RCOI form signed for everyone listed as members of the study team on the R&A form

SPA TASKS/RESPONSIBILITIES

1. Negotiate legal terms of the agreement with sponsor on behalf of the PI and the University.注意，要确保水疗中心的努力与部门的优先级保持一致，水疗中心优先考虑已将提案记录提交给水疗中心进行预算审查的协议。

2.确保构建并上传到开票范围分析。SPA在开始进行覆盖范围分析时创建了单独的协议（AGT）记录（链接到CTA AGT和CTA PD记录（如果有））。一旦CA AGT记录完成，Start将发送通知。

3.将与PI签名的最终协议路由机构签署者通过Start签名。

• Prior to routing for institutional signature SPA will confirm the below items have been completed and/or uploaded under the PD record:

i. Coverage analysis AGT record status of “Approved”

ii. Final Agreement with PI signature

iii。提交给水疗中心的PD记录（必须通过启动自动E SIG路由由PI和DMO签署）

iv。PD记录准确完成

v. Ensure all required documents have been uploaded under the PD record

4. Submit Proposal Record (PT) to Post Award Finance via START to set up a financial account for the study.

5. Post Award Finance team send out award set up notice via email.