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Sponsored Projects Administration

临床试验协议(CTAs) govern the terms of research between the University and set the expectations and responsibilities of the parties. Industry initiated clinical trials are executed for trials following a sponsor- or investigator-initiated protocol.

Generally CTAs are funded by pharmaceutical and medical device companies, and are an important part of the Food and Drug Administration (FDA) approval process. The data from CTAs help to ensure the safety and efficacy of the drug or device being brought to market.

COMPONENTS OF CTA/SRA

Agreement Parties

所有CTA都是大学与赞助商之间的协议。PI可以被任命为大学雇员,但不会被命名为协议的当事方。

AahrppStandards

UTHealth获得了人类研究保护计划认证协会的认可(beplay苹果手机能用吗Aahrpp). As such, all CTAs executed by the University must includestandard languagewhich address AAHRPP’s overarching principles for protecting human research participants.

Confidentiality

As an academic medical institution, the University strives to create a vibrant academic environment. As such, the University cannot accept language which seeks to make raw source data or documentation, including the results of the study, confidential. Additionally, the University is an agency of the state of Texas, and therefore all agreements entered into by the University are subject to public disclosure under theTexas Public Information Act

Publication

Timely publication and dissemination of the results of research performed by faculty are important principles behind UTHealth’s mission as an academic medical institution. Research sponsors are afforded a period of time to review and comment upon on the content of such publications, to protect intellectual property, and to ensure their confidential information is not improperly published, but the University does not accept terms that restrict faculty from freely publishing the results of their research.

Indemnification

在所有临床试验协议中均解决了赔偿。在赞助商发起的临床试验协议中,大学教职员工遵循赞助商的指示。因此,大学不对在临床试验期间进行的工作或赞助商使用该研究结果的任何伤害或损害负责。作为国家机构,该大学受到德克萨斯州的法律和宪法的约束,只能赔偿其疏忽。

Intellectual Property

UT系统和UTHealth鼓励发展nt of intellectual property to enhance research, scholarship, teaching, and discovery for the best interest of the public, the creator, and the research sponsor. For industry initiated clinical trials, patent rights for inventions made in the direct performance of a sponsor-developed clinical trial protocol, involving little or no PI involvement in the conception or development of the protocol, are generally granted to the sponsor. However, the University reviews patent terms on a case-by-case basis.

Subject Injury

Under most circumstances, if a study participant sustains any injury or adverse event as a result of their participation in the study, the University will arrange for the care of subject. For industry initiated clinical trials, University policy specifically prohibits billing the study subject or a third-party for the costs of treating such injuries. Therefore, all research-related subject injuries resulting directly from study drug or device administration, or procedures carried out in accordance with the sponsor-designed protocol are the financial obligation of the sponsor.

Insurance

为了支持本节中详细介绍的赔偿,包括受试者的责任,发起人必须保持足够的保险水平。该大学是自给自足的,在协议期间,将维持有效的保险,以承担其赔偿义务。

Governing Law

该大学是德克萨斯州的宪法公司,大学接受的合同也将根据德克萨斯州法律进行解释。大学还将考虑有关此问题的合同沉默,但通常不会遵守任何其他管辖权的法律。

付款条件

Generally,clinical trial budgets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indirect costs

过程

临床研究金融与管理(CRFbeplay苹果手机能用吗A)团队负责审查谈判和执行CTA。该部门负责完成并提交合同Review & Approval (R&A) Form, negotiating the budget with the sponsor, and submitting the requisite documents to the appropriate review boards (Institutional Review Board, Animal Welfare Committee, etc.).

Departments should forward all CTA drafts - and company contact information - toCRF@uth.tmc.edu进行审查和谈判。在CRFA谈判协议的同时,该部门应同时完成其职责,如上所述。

部门任务/责任

  • Submit protocol and other information provided by sponsor to the Institutional Review Board (IRB).
  • 通过电子邮件将合同提交给水疗中心crf@uth.tmc.edu
  • 与CRFA合作完成覆盖范围分析
  • 通过学习团队和CRFA制定内部预算
  • 与赞助商协商预算。
  • 完成Review and Approval Formand submit tocrf@uth.tmc.edualong with the final budget.
  • Route the final agreement for PI signature and submit to SPA

水疗任务/职责

  • Negotiate legal terms of the agreement with sponsor on behalf of the PI and the University
  • 协助部门制定覆盖范围分析和内部预算。
  • Route the final agreement with PI signature for institutional signatory to sign.
  • Send partially executed agreement to sponsor
  • 将完全执行协议的副本发送给部门和裁决融资。
  • Coordinate with Post Award Finance for FMS Account Setup.
  • One year after the study is closed in the IRB CRFA team will initiate FMS Account Closeout Process.
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