At the UCI Center for Clinical Research (CCR), we recognize the challenges that investigators can face when navigating the intricacies of the clinical research system. That's why we're here to help. Our highly specialized Start-Up, Clinical Operations, and Regulatory Teamsare fully dedicated to supporting our esteemed investigators throughout the entire process, from initial communication to site initiation and every crucial step in between. With their unwavering focus, our team members are well-versed in overcoming the complexities of the system to ensure that our investigators receive the comprehensive support they require to achieve success. Below outlines the processes that occur when starting a clinical research project at UCI, with the activation timeline goal of 120 days (starting from when the study is reviewed by our Internal Feasibility Committee).
Sponsor or PI expresses interest in conducting a clinical research study at UCI and connects with one of our Clinical Research Managers or the Business Development Team.
CCR will help coordinate the sponsor to visit UCI for a SQV to verify we have the appropriate facilities, staff, equipment, and patient population necessary to complete the study. The sponsor and PI will then concur on whether to pursue entering into a contract to conduct the study at UCI.
Once the sponsor submits all the essential documents to our team - including the study protocol, the informed consent form, study budget template, and initial agreement - our clock officially starts. The study then goes to our weekly internal feasibility committee (IFC), and once it's approved, the three parallel start up processes are under way.
Parallel Start-up Submissions
The respective IRB Submission, Coverage Analysis/Budget Negotiation, and Contract Negotiation processes all run concurrently for optimal efficiency in study activation. These processes culminate in Document Alignment to ensure the accuracy of details across all documents before final signoffs are conducted.
IRB Track
Budget Track
Contract Track
The CCR Regulatory Team completes IRB submission to IRB for local UCI review or single IRB review (UC Reliance)
Submission includes protocol, informed consent form (ICF)/ assent form, and other supporting regulatory documents (i.e. drug or device brochures, conflict of interest, etc.).
Note: IRB approval letter does not allow PI and study team to begin enrollment, all institutional and sponsor approvals must be in place to open the study
The CCR Start-Up Team manages the process of building the protocol calendar in OnCore, completing the Coverage Analysis, and oversees Budget and Budget Negotiations.
The CCR Start-Up Team submits the study documents (i.e., protocol, draft budget and contract) to Sponsored Projects Administration (SPA) or Applied Innovation (AI) in Kuali Research (KR) and emails the KR proposal link to the SPA/AI team.
SPA/AI negotiates the contract to reach final mutual agreement of contract terms.
The Contract Track includes the KR Proposal Process as well as a convenient DocuSign workflow to expedite contract execution:
Document Alignment
Document alignment is an important and institutional requirement for PIs to ensure that all documents related to a clinical trial are accurate, complete, and consistent with one another to ensure financial risk is mitigated. Document alignment involves reviewing and comparing all study-related documents to identify discrepancies, inconsistencies, or errors that could impact the study.
Once alignment is complete, the CCR Start-Up Team submits KR signoff in order to execute the contract and allow the study to open.
