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Sponsored Projects Administration

Clinical Trial Agreements (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

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.

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 the Texas 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.

 

Intellectual Property

The UT System and 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.

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

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.

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 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 - to CRF@uth.tmc.edu for review and negotiation. While CRFA is negotiating the agreement, the department should be concurrently completing its responsibilities as detailed above. 

DEPARTMENT TASKS/RESPONSIBILITIES

SPA TASKS/RESPONSIBILITIES