CU Medicine/University
Contract Routing
T.K. Keith - Manager of Compliance, Training, and Real Estate Coordination
Services
University Financial Services
CU Medicine Contracts
4 Types of contracts go through CU Medicine:
Consulting Contracts: These are agreements for consultation services performed
for a for profit entity (typically), whereby the faculty member is requested to give
intellectual advice or an opinion on subject matter that may or may not be
directly related to patient care. The payment is typically for a faculty members
time only and based on a fixed rate (as opposed to cost reimbursable, or salary
percentage)
Clinical Contracts: Agreements other than managed care contracts specifically
where the faculty member is providing patient care
Administrative Contracts: Agreements where the faculty member is providing
administrative (i.e., director of a new clinic, director of a lab) support
Med Legal Contracts: Contracts where the faculty member is providing support
for a legal proceeding
CU Medicine
Consulting Contracts
An agreement can run through CU Medicine as a consulting if:
• The faculty member is executing a scope of work that was created by an outside
entity, and is expected to do so without variation
• The faculty member is being asked to analyze company data is not related to any
research done at the University
• There is no new IP expected to be developed in performing the work
• There is no scientific uncertainty regarding the faculty members ability to perform
the work and provide the stated deliverables
• There is no expectation foe faculty member to be named on any publication
• The budget is based on a fixed rate (for example, $100 per hour, or $1000 per
event)
• The faculty member is providing advisory opinions only, and no University
resources other than PI time are being used
• There are little or no attributes that indicate the project is a “sponsored project
(see list below)
• It involves training for a sponsor that does not take place in University owned
space, and does not provide CME or GME credits.
CU Medicine
Consulting Contracts
Examples of Consulting Agreements:
• A Faculty Member is asked to consult with a pharma company to provide advice on
how to run a clinical trial at an hourly rate
• A Faculty Member is asked to service on advisory council 4 days a year, at a per day
rate of $1000 per day
• A Faculty Member is asked to provide expert opinions on research study design for
an hourly rate, and no actual research is being done by Faculty Member
• A Faculty Member is asked to design an online survey for a fixed price of $5000
• A Faculty Member is asked to provide input on product design at the design stage,
but is performing no research related to the product and no expectation of
intellectual property ownership by Faculty Member
• A Faculty Member is asked to take a survey to provide feedback in an area of their
expertise
•A Faculty Member is asked to take part in a study section or peer review panel more
than one time (one time study sections can be done personally by Faculty Members
as exempt Honoraria)
University Contracts
University contracts include contracts for:
Sponsored Project Contracts: Agreements for basic and applied
research, and other sponsored activities
Revenue/Fee for Service Contracts: Agreements for service projects for
which an external client requests deliverables generated by standard
procedures and established theories, methods and standard
experiments, and involving University resources other than just PI time
University Contracts
An engagement needs a University contract if:
Direct Federal Funding (with CFDA number), including Federal Flow Through
where Federal Terms are flown down via Subcontract (As opposed to where the
faculty member is a contractor/vendor only)
State Funding (Except where the work is clinical; CU Medicine does receive state
Funding for clinical work)
Resources other than just Principle Investigator (“PI”) time, such as lab
equipment or space on campus
Multiple PIs
Compliance/regulatory components (human/animal subjects, export control, etc)
Expectation by the PI to be named on a publication or to develop intellectual
property owned by the University
A formal proposal or award document (unless SOW is clinical)
An itemized budget which may place restrictions on how funds can be spent
and/or re-budgeted
Cost-sharing required in order to receive the funding
University Contracts
An engagement needs a University contract if:
A specific commitment regarding the level of personnel effort (unless
work is clinical)
A fiscal report, activity report, and/or external audit during the course
of the work or at the end of the project period
A proposed agreement with the sponsor provides for the disposition of
tangible or intangible property
Unexpended funds that must be returned to the sponsor at the end of
the activity
The need to subcontract a portion of work to another entity
Pre-Research work that will eventually lead to research work performed
by the Faculty Member (For example, clinical trial start up work)
Training for CME or GME credits, or training that takes place in
University owned space
University Contracts Examples
Examples of Sponsored Projects:
A Faculty Member wants to submit an application with a Foundation
A sponsor is providing a subcontract with flow through of Federal terms
A Faculty Member is asked to conduct research for an industry sponsor
A Faculty Member is asked to analyze data for an industry sponsor and
such analysis has the potential to develop IP for the Faculty Member
A Faculty Member is being paid by a sponsor to develop the protocol for
a clinical trial that will be run at the University
Examples of Revenue/Fee for Service Projects:
Multiple Faculty Members and staff in a department are asked to run a
conference for a sponsor at the University
A sponsor wants to pay for lab work done by a University Core
An industry sponsor requests to use the University Vivarium to train its
employees on surgical equipment
An industry sponsor wants to contribute money/equipment for a
conference run by the University
Processes
University Process
Sponsored Projects route through
Infoed
Revenue/Fee For Service
Contracts can be sent directly to
OGC.Revenue@ucdenver.edu
GME contracts to
Ashley.Walter@ucdenver.edu
CME requests to
Pam.Welker@ucdenver.edu
University to coordinate with CU
Medicine if unsure where to
route
CU Medicine Process
Draft contract (Word version) &
CIF form submitted into Egnyte
Task assigned to Jo Dregney for
intake
During Legal Prep, contract will
be reassigned to OGC if
appropriate & marked as
“Declined” in Egnyte
University will determine
treatment
Questions
Points of Contact for questions:
Michelle Woulfe (CU Medicine-Finance/Contract Operations);
(Michelle.Woulfe@cumedicine.us)
TK Keith (University-Financial Services);
(Thomas.Keithiii@cuanschutz.edu)