Negotiation of Clinical Trial Agreements
Sponsored Programs Administration (SPA) is responsible for
reviewing, negotiating, and executing agreements, including
clinical trial agreements (CTAs), from external funding sources
(e.g., pharmaceutical companies). As a public, nonprofit
educational institution, the University is bound by certain
policies and regulations regarding what it can and cannot accept in
a CTA. These policies are designed to protect the welfare of
individuals participating as a research subject; foster the
University's basic mission of teaching, research, and public
service; and minimize the various forms of liability associated
with human research.
Principal Investigators (PIs) are encouraged to discuss all
aspects of the clinical trial with SPA prior to the start of
negotiations. For instance, apprising SPA of the PI's
involvement in the protocol development and/or study design raises
intellectual property implications that may result in the
negotiation of different or additional contractual terms.
The contractual language proposed by the University during
contract negotiations is predicated upon the following:
- That the clinical investigation is conducted under a protocol
that is a FDA Phase I, II, II, or IV drug study or a FDA regulated
medical device study;
- That the sponsor provides its proprietary product (e.g., drug
and/or device) to the University for the purpose of conducting the
sponsor-initiated or investigator-initiated clinical trial;
- That the sponsor provides its study protocol to the University,
if it is a sponsor-initiated clinical trial
- That the PI is the author of the study protocol, if it is an
investigator-initiated clinical trial; and
- That the sponsor will fully fund the cost of the study (i.e.,
no work will be supported in whole or in part with other
When negotiating CTAs, the University's primary focus is on
securing acceptable contract clauses regarding high-risk issues
(e.g., indemnification, confidentiality, publication rights, data
ownership, patent rights, and subject injury).
Although each agreement is reviewed on a case-by-case basis,
there are a number of key contractual provisions that are common to
most CTAs. Some of those provisions and the accompanying
explanation as to the University's handling thereof are as
PARTIES TO THE AGREEMENT
CTAs should only be made by and between the study sponsor and The
Regents of the University of California, on behalf of its Riverside
campus. The PI, although an employee of UCR, does not have the
delegated legal authority to enter into CTAs on behalf of The
Regents and, therefore, may not be a named party to the
agreement. That said, an acknowledgement block may be
included at the end of the CTA whereby the PI may acknowledge that
s/he has read the terms of the CTA and understands his/her
obligations to comply therewith.
Note: Since UCR does not own a medical facility conducive
to conducting clinical trials, UCR will need to contract with
another entity for the use of their clinical facility and/or
clinical support services. While such contractual arrangement
will typically be handled in a separate agreement (e.g.,
subcontract) between The Regents and that other entity, there could
be instances where a study sponsor, instead, may require such other
party to be a named party to the CTA.
CTA typically contain a payment schedule which includes a per
subject fixed-price. Such schedules usually provide for
periodic payments at regular intervals or payments upon the
completion of milestones (e.g., enrollment of a certain percentage
of subjects, submission of a certain number of case report forms,
The University cannot underwrite expenses for the sponsor;
therefore, the University requires a minimum advance payment,
typically between of 10-20% of the total anticipated cost, upon
execution of the agreement. When a project involves significant
start-up costs, the University may require a larger initial
When conducting a sponsor-initiated clinical trial whereby the
sponsor is the author of the protocol, the University is following
the sponsor's instructions. As a public, non-profit educational
institution, UCR cannot bear the financial responsibility for any
injury (including damages) resulting from the performance of such a
clinical trial. Consequently, UCR requires the sponsor to
maintain a policy or program of insurance sufficient to support its
indemnification obligation. The sponsor's obligation to assume all
financial responsibility, however, does not apply to injury that
is: (i) caused by UCR's failure to adhere to the protocol; (ii)
failure to comply with FDA or other governmental requirements; or
(iii) caused by the negligence of a faculty member or the
UCR must maintain an open academic environment to fulfill its
mission, and meet its fiduciary responsibilities, as a public
educational institution. Clinical trials involving the use of a
sponsor's confidential information should be limited to that
information necessary for the performance of the clinical trial,
and clearly identified by the sponsor as confidential.
Raw source data or documentation generated by the University
during the conduct of a clinical study cannot be considered to be
owned by the sponsor, nor can it be considered or treated as
In addition, any agreements entered into by the University are
subject to public disclosure under the State of California Public
Timely publication and dissemination of research/study results are
important principles behind the academic freedom afforded to each
UCR faculty member. The publication provision, however, may provide
a sponsor with a pre-publication review and comment period during
which the sponsor may request the removal of its confidential
information from the proposed publication. Additionally, the
sponsor may promptly make arrangements for the protection of its
intellectual property prior to publication. UCR is also
willing to delay dissemination of study results for a reasonable
period of time to accommodate multi-site studies. However,
the resulting agreement cannot restrict UCR faculty from freely
publishing UCR's research/study results.
Sponsors of UCR research are usually granted patent rights in
accordance with University policies. However, UCR may grant greater
rights to sponsors of sponsor-initiated clinical trials that meet
all of the following criteria:
- The clinical investigation is an FDA Phase I, II, III or IV
drug study or an FDA regulated medical device study.
- The sponsor provides its proprietary product and
study protocol to the University for the clinical
- The cost of the clinical investigation, conducted according to
the sponsor's protocol, is fully funded by the sponsor and is not
supported, in whole or in part, with any other funds, including
Federal funds, gift funds or foundation funds.
- There are no known third-party rights to intellectual property
of The Regents that would be compromised by granting rights to the
clinical trial sponsor.
- All University requirements regarding the administration of
agreements with private sponsors for drug and device testing using
human subjects have been satisfied.
If all of the above criteria are met, UCR may grant to the
sponsor a certain range of rights to inventions made in the direct
performance of the clinical trial protocol; provided, however, that
with regard to Phase III or IV trials, there must have been little
or no investigator involvement in the conception or development of
the protocol. Notwithstanding the foregoing, UCR reviews
patent terms on a case-by-case basis and prefers to do so with a
thorough understanding of the work contemplated.
As a matter of UC policy, in the event a study subject is injured
resulting directly from the administration of study drug or the
study procedures carried out in accordance with a sponsor-designed
protocol, UCR will provide reasonably necessary medical treatment.
UC policy specifically prohibits billing the study subject or a
third-party for the costs of treating such injuries. Therefore, UCR
requires reimbursement for the cost of such treatment from the
sponsor. Human subject welfare is a primary concern for the UCR and
exceptions to these terms cannot be accommodated.
To support its indemnification obligations, the sponsor must
maintain a sufficient level of insurance.
The University of California is self-insured and, during the
term of the agreement, will maintain in force adequate insurance to
cover its indemnification obligations.
The University of California is a constitutional corporation of
the State of California and contracts accepted by the University
are to be interpreted under California Law. UCR will also
consider contractual silence regarding this issue.
Each of the parties to the CTA must have the ability to terminate,
upon the giving of reasonable notice. In the event of early
termination, UCR will seek reimbursement from the sponsor for all
costs and uncancellable obligations incurred up to the date of
termination. In addition, untimely withdrawal from the
protocol could jeopardize the welfare of human subjects; therefore,
the UCR shall request that the sponsor cooperate with UCR to safely
withdraw subjects from the protocol.
USE OF NAME
California Education Code Section 92000 provides that the use of
the name "University of California" is the property of the State of
California and that the sponsor's use of such name, campus, or logo
must also comply with such section. Accordingly, the sponsor
is prohibited from using UCR's name in connection with any
advertisement, press release, or other form of business promotion
or publicly, or to suggest that it endorses a product or service.
A sponsor may, however, use UCR's name to fulfill its
obligations as required by law, or by otherwise requesting prior
written approval from UCR.