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Frequently Asked Questions
How is research defined, and why is that important?
What facilities and administrative cost
rate should be used for clinical trials?
Why is a written agreement necessary?
Who has signature authority to sign a University
clinical trial agreement?
How long does it take for a clinical trial
agreement to be approved?
How is research defined, and why is
that important?
Sponsored activities performed under grants, contracts,
or other agreements, which falls into one of three categories:
Organized Research - Systematic investigation
whether basic or applied designed to develop or contribute
to general research knowledge. Organized Research falls
into one of two categories:
Clinical
Trial - The controlled, clinical testing in
human subjects of investigational new drugs, devices,
treatments, or diagnostics, or comparisons of approved
drugs, devices, treatments, or diagnostics, to assess
their safety, efficacy, benefits, costs, adverse
reactions, and/or outcomes. Such studies may be
conducted under an industry-developed protocol or an
investigator-developed protocol. Financial support for a
clinical trial must be provided by a for profit
entity. Click
here for more information
(applicability, guidance, etc.)
Research
- All research other than the Clinical Trial awarded
in response to solicited proposals and generally made
on the basis of both scientific or technical merit and
under an agreed cost to conduct the work specified.
Research Agreements are generally characterized as "Contract
or Subcontract" under the following types:
Cost
Reimbursement: A
contract that specifies a maximum amount of funding
and under which the Sponsor is obligated to reimburse
the University only for actual costs incurred.
Fixed Price:
A contract that specifies an agreed flat fee or flat
price in which the Sponsor is obligated to pay the
University for product or service.
Flat Rate: A contract
that specifies an agreed flat rate in which the Sponsor
is obligated to pay the University for each unit of
service or each product.
Instruction - Teaching or training designed
to develop or contribute to general research knowledge
offered for credit or non-credit through academic departments
and extension.
Other Sponsored Activity - Programs or projects
that involve the performance of work conducted under other
than Organized Research or Instruction.
Top
What facilities and administrative
cost rate should be used for clinical trials?
The University of California Office of the President
(UCOP) has approved an exception to overhead policy to allow
the use of a special clinical trial indirect cost rate of
26.00% Total Direct Costs (TDC as of November 1, 2005) for certain clinical trials.
Criteria for application of this special rate is as follows:
1.
The study must meet the clinical trial definition given
above, and
2. The study must be fully supported by an industry
sponsor, and
3. A contract meeting University requirements for
industry-supported clinical trials must be executed with
the sponsor.
Examples
of Clinical Trial Facilities and Administrative Cost
Rate Applications
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Why is a written agreement necessary?
Whenever a company or other outside Sponsor funds research
at the University, the parties must sign a written agreement.
This agreement must define the scope of work, establish
acceptable payment arrangements, and address important issues
such as the right to publish research results, protection
of confidential information, and indemnification of third
parties and/or case injury. UCLA has developed a standard
Research Agreement that has received prior approval by legal
counsel for the University, so it can be completed and signed
with few delays if accepted by the Sponsor.
Top
Who has signature authority to sign a University clinical
trial agreement?
Authority to negotiate and execute research agreements is
delegated to a few business officials on each campus. At
UCLA, responsibility for executing research agreements rests
with the Office of Contract & Grant Administration. Individual faculty
members are not authorized to sign such agreements on behalf
of the University and should not sign any proposed agreements
received from a prospective Sponsor without first contacting
the Office of Contract & Grant Administration.
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How long does it take for a clinical trial agreement to
be approved?
If the Sponsor agrees to use the standard UCLA Research
Agreement without negotiation of additional terms, an Agreement
can be signed by the Office of Contract & Grant
Administration as soon as the completed
proposal package with all signatures and approvals is received
from the Faculty Member. If the Sponsor requires the negotiation
of additional terms and conditions or has an extended internal
review period, substantial delays can occur.
NOTE:
Some problematic provisions that could delay negotiation
of a Clinical Trial or Research Agreement are: (1) Publication
restrictions; (2) Sponsor's ownership of or unrestricted
rights to develop Intellectual property; (3) University
indemnification of third parties; and (4) Recovery of less
than all University costs.
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update on 09/15/2006
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