Upon receipt and subsequent review of a sponsor-developed
protocol, the PI and applicable subcontractor (whose facility
and/or clinical support services would be utilized by UCR in the
conduct of the clinical trial) will jointly conduct a feasibility
assessment to determine whether or not to move forward with the
clinical trial. Such assessment should address the following
- Does the protocol provide scientific value?
- Can study subjects be recruited, given the enrollment
- Does the budget support the work to be performed?
- Do we have the resources to conduct the research study?
Note: The determination to participate in the conduct of
the clinical trial should be predicated on the ability to answer
affirmatively to all of the above questions.
Additional factors to consider during the feasibility assessment
process include Medicare coverage analysis, technical
considerations, the particular services and facilities needed from
the subcontractor for a given study, etc.