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 Standards

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

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

Indemnification 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，以实现公众，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会授予赞助商的临床试验方案，几乎没有PI参与该方案的概念或制定，通常授予赞助商。但是，大学逐案审查专利条款。

Subject Injury

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，则大学将安排受试者的照顾。对于行业发起的临床试验，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费用。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。

Insurance

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.

Governing Law

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

Generally, clinical trial budgets are based on a fixed price-per-subject amount with a payment schedule. Such schedules usually provide for regular payments upon the completion of milestones (e.g., enrollment of a certain percentage of subjects, submission of a certain number of case report forms, etc.). These payments should include all applicable indirect costs.