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 questions:
- Does the protocol provide scientific value?
- Can study subjects be recruited, given the enrollment criteria?
- 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.