C1-2: The Division of Research Comprehensive Clinical Research Unit Pre-Award Process and Budgeting for Clinical Trials

Abstract

Background/AimsLaunched in 2008, the Comprehensive Clinical Research Unit (CCRU) is charged with providing Kaiser Permanente Northern California (KPNC) research investigators pre-award services including industry and non-industry sponsored clinical trial budgeting and proposal preparation. The CCRU provides first-line communication for the Principal Investigator (PI) for feasibility review of study protocols, clinical trial budgets and clinical trial and sponsored research agreements. The purpose of this presentation is two-fold: (1) describe CCRU’s comprehensive pre-award services and (2) describe the process and tools employed by the CCRU for developing and negotiating clinical trial budgets.MethodsThe CCRU has implemented a pre-award service model in which the CCRU reviews and conducts a comprehensive feasibility assessment of proposed clinical trials, designs a clinical trial budget, directly negotiates the budget with the sponsor, and concludes the budget process by approving (or rejecting) the budget and budget terms. The CCRU Lead Financial Analyst spearheads the budget development and negotiation, and works in tandem with the Revenue group for billing coverage analysis. Post-award functions and Clinical Trial Agreement (CTA) approval are under the auspices of KFRI’s Grants and Contracts office. The CCRU employs a budget template, the Site Assessment Survey (SAS) which provides line-item delineations of pass-through costs, per-subject procedures costs, invoiceable charges, staff salaries, and overhead cost. Time and effort analysis, and standard versus research care determinations are performed with PI participation. Procedures costs are based on the most current KPNC Master Fee Schedule.ResultsThe pre-award program offers KPNC investigators a directed and streamlined approach to clinical trial budgeting and other clinical trials operations functions, and helps consolidate clinical research administration overall. The overall pre-award process has yielded more transparent and defensible budgets, conducted in a highly collaborative fashion, with input from the PI, the CCRU management team, Revenue group, and KFRI Grants and Contracts.ConclusionsThe CCRU pre-award program provides high quality and timely clinical trial pre-award service that includes study feasibility analysis, Medicare Coverage Analysis, study budget development, and compliance, thus enhancing KPNC clinical research capabilities. The pre-award program is critical to the sustainability and growth of the KPNC research enterprise.