Agreement Parties

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.

Confidentiality

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作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一家机构，因此，大学达成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出版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.

Intellectual Property

UT系统和UTHealth encourage the development 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.

受试者受伤

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.

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

一般来说，clinical trial budgetsare 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间接成本.