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赞助项目管理

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人员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的数据有助于确保被推向市场的药物或设备的安全性和功效。

CTA/SRA的组件

协议各方

All CTAs are agreements between the University and the sponsor. The PI may be named as an employee of the University, but will not be a named as a party to the Agreement.

Aahrpp标准

UTHealth is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). As such, all CTAs executed by the University must include standard language which address AAHRPP’s overarching principles for protecting human research participants.

保密

作为一家学术医疗机构,大学努力创造一个充满活力的学术环境。因此,大学不能接受试图制定原始源数据或文档的语言,包括研究结果,机密。此外,大学是德克萨斯州的机构,因此,大学签订的所有协议均受公开披露德克萨斯公共信息法.

出版物

及时出版和传播教师进行的研究结果是Uthealth作为学术医疗机构使命的重要原则。beplay苹果手机能用吗beplay苹果手机能用吗研究赞助商有一段时间来审查和评论此类出版物的内容,保护知识产权,并确保其机密信息不会被不当发布,但是大学不接受限制教师自由发布的术语他们的研究结果。beplay苹果手机能用吗

保障

保障is addressed in all clinical trial agreements. In a sponsor initiated clinical trial agreements, the University faculty members are following the sponsor’s instructions. Therefore, the University cannot be held responsible for any injury or damages resulting from work performed during the clinical trial, or from the sponsor’s use of the University’s results of the study. As a state agency, the University is subject to the laws and Constitution of Texas, can indemnify only to extent of it is negligence.

知识产权

UT系统和UTHealth鼓励知识产权的发展,以增强研究,奖学金,教学和发现,以期为公众,创造者和研究赞助商的最大利益。beplay苹果手机能用吗对于行业启动的临床试验,发明的发明专利权利通常授予赞助商的临床试验方案,几乎没有PI参与该协议的概念或制定,通常授予赞助商。但是,大学逐案审查专利条款。

受试者受伤

在大多数情况下,如果研究参与者因参与研究而受到任何伤害或不良事件,则大学将安排对学科的照顾。对于行业开始的临床试验,大学政策专门禁止计费研究主题或第三方治疗此类伤害的成本。因此,直接由研究药物或设备给药beplay苹果手机能用吗造成的所有与研究相关的受试者伤害,或者根据赞助商设计的方案进行的程序是赞助商的财务义务。

保险

To support the indemnification detailed in this section, including subject injury liabilities, the sponsor must maintain a sufficient level of insurance. The University is self-insured and during the term of the agreement will maintain in force adequate insurance to cover its indemnification obligations.

管理法律

The University is a constitutional corporation of the State of Texas and contracts accepted by the University also will be interpreted under Texas law. The University will also consider contractual silence regarding this issue, but generally will not subject itself to the laws of any other jurisdiction.

Payment Terms

通常,临床试验预算基于带有付款时间表的每项固定价格金额。这些时间表通常在完成里程碑后定期付款(例如,一定比例的受试者的注册,提交一定数量的案件报告表等)。这些付款应包括所有适用的间接费用。

PROCESS

The Clinical Research Finance and Administration (CRFA) team is responsible for the review negotiation, and execution of CTAs. The department is responsible for completing and submitting to Contracts the评论与批准(R&A)表格,与赞助商谈判预算,并将必要文件提交适当的审查委员会(机构审查委员会,动物福利委员会等)。

部门应将所有CTA草稿以及公司联系信息 -crf@uth.tmc.edufor review and negotiation. While CRFA is negotiating the agreement, the department should be concurrently completing its responsibilities as detailed above.

DEPARTMENT TASKS/RESPONSIBILITIES

  • 提交赞助商提供的协议和其他信息向机构审查委员会(IRB)提交。
  • Submit Contract to SPA by emailing it tocrf@uth.tmc.edu.
  • Work with CRFA to complete the coverage analysis
  • Develop the internal budget with the study team and CRFA
  • Negotiate the budget with sponsor.
  • Complete the审查和批准表并提交crf@uth.tmc.edu以及最终预算。
  • 路由PI签名的最终协议,并提交给水疗中心

SPA TASKS/RESPONSIBILITIES

  • 代表PI和大学与赞助商协商协议的法律条款
  • Assist department in developing the coverage analysis and internal budget.
  • 将与PI签名的最终协议路由机构签署者进行签名。
  • 向赞助商发送部分执行协议
  • Send copy of fully executed agreement to department and Post Award Finance.
  • 与FMS帐户设置的邮政裁决协调。
  • 研究结束后一年,IRB CRFA团队将启动FMS帐户关闭过程。
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