Applying for CCTS Clinical Services Core User
The process for CCTS Clinical Trials Support Foundation of Discovery (CTS) application is outlined in Figure 1. Prior to application, investigators should ensure that all study team members have completed CITI training in GCP and in the protection of human subjects research. Investigators seeking extramural funding should discuss their clinical research nursing and space needs at the earliest planning stages of grant proposal development. We ask that you budget for 100% of the CCTS Clinical Services costs for your protocol, whenever possible. Once you have received your Notice of Award, you may be eligible for CCTS financial support to cover part of your costs for clinical research nursing.
The CCTS is providing a new electronic resource to facilitate requests for clinical research nursing and space. ProTrackS (Project Tracking System) is a web-based research management system that provides a central portal to researchers and their study teams to browse for research services as well as submit service and pricing requests from the CCTS. This new platform will allow clinical investigators to self-select requests for CCTS resources across any of our four Foundations of Discovery, including Clinical Trials Support, Population Health, Precision Medicine, and Workforce Development. ProTrackS can be found at https://protracks.ccts.utah.edu. You may log in with your campus unid and password to request services.
As a preliminary step to application for CSC use and determining the subsidy available from the CCTS, the investigator will register their their project using ProTrackS. This internet form includes information on the investigator’s academic rank, grant history, and intended funding source for project, in order to characterize the project for subsidy, as outlined in Table 2.
The CCTS Clinical Services nurse manager or designee will meet with each applicant investigator to evaluate requested nursing effort, total clinical research visit time, and other required services for their protocol. Ideally, this face-to-face effort assessment should occur earliest in the planning stage for any study that may use the clinical research resources of the CCTS and be completed before performance in any of the CCTS clinical research venues . Nursing effort and time estimates from that face-to-face meeting will be used by the CCTS administrator to estimate costs for your protocol and will be described in a written cost estimate. It is expected that investigators will use this estimate to apply for extramural funds or finalize budget negotiations with industry partners.
Investigators conducting sponsored clinical research will be charged $111/hour for nursing services. In addition, all investigators will be charged $36/hour for time in the CCTS clinical research space. A onetime $200 Administrative Start-up fee will be applied to the first billed invoice. Invoices will reflect the proportion of the visit time that requires nursing effort, the CCTS clinical research RNs carefully track their utilization by protocol.
Modifications to the protocol that may affect the protocol effort will be revisited with a second effort analysis prior to review of the final CSC application by the Internal Advisory Committee (see below).
Figure 1. Clinical service application process
Investigators seeking grant support from extramural funding agencies (such as the NIH or American Heart Association) will benefit from meeting with our staff prior to submitting their grant proposal. CCTS staff will write a letter of support, to be include with the grant proposal, which will outline expected CSC effort and possible subsidy to the protocol should funding be secured and the protocol accepted for CSC performance. In the event that the protocol as funded is significantly different from that initially evaluated, subsidy may be altered from that designated in the Letter of Support.
Internal Advisory Committee Review
Applications to use the CSC are reviewed by the CCTS Internal Advisory Committee (IAC). This review will occur AFTER funding for the CSC project has been secured, whether from extramural sources, intramural seed grants or industry partners. The IAC is chaired by the Clinical Trials Support Foundation Director, and comprised of basic and clinical scientists from University departments whose Investigators may use the CCTS for human subject studies, including medical disciplines, Pharmacy, Nursing and Physical Therapy. In addition to human subject safety and risk, the IAC evaluates each protocol on scientific merit, feasibility, statistical rigor, likely academic benefit to the institution and investigator, and utilization of CCTS resources. In this context, the IAC will also review protocol subsidies within the guidelines of our financial structure, and adjudicate requests for CSC Merit Awards.
A tiered application review process will be used based on the scale of requested CSC nursing effort and time. Applications requesting less than $10,000 in CSC visit time and nursing services (about 50 hours) will be administratively reviewed. Those requesting $10,000 to $100,000 in services (50 to 500 hours) will receive a standard review. Applications requesting more than 500 hours or $100,000 in services over the life of the study will require a letter of support from the investigator’s department, and will be primarily reviewed by two IAC members. For reference, in 2011, the CSC supported approximately 6700 hours of study time, so a 500 hour study approaches 8% of total current yearly CSC capacity.
The CSC has capacity limited by nursing FTEs and space, and cannot accurately estimate total effort from its approved protocols. It is recognized that most studies do not recruit the expected number of participants. Scheduling for CSC is currently competitive, though it favors NIH protocols. Thus, while IAC approval permits use of the CSC and its resources, it does not guarantee timely scheduling access for any particular protocol.