At the UCI Center for Clinical Research (CCR), we take great pride in our fully centralized team of 80 highly skilled professionals, all meticulously trained to fulfill every clinical research service need in-house. We are fully equipped to support our esteemed UCI investigators every step of the way, from study inception and start-up, to devising a robust recruitment plan, coordinating the study, and ultimately ensuring successful study closure. With a dynamic group of individuals, our team is adept at providing dedicated support and operational excellence throughout the entire study process. Our clinical research coordinators, who boast extensive experience across a diverse range of therapeutic areas, are committed to offering unparalleled support and guidance to ensure the success of your study. Below is a list of areas that the CCR will facilitate for our investigators.
CCR is dedicated to opening new avenues for UCI researchers to conduct clinical research studies on campus. Our dynamic Business Development Team is actively forging relationships with leading clients, including pharmaceutical companies, medical device manufacturers, and contract research organizations (CROs), to understand their requirements for clinical research services at UCI. Our team's foremost objective is to form strategic partnerships that culminate in the successful execution of clinical research studies. If you are an aspiring UCI investigator seeking to delve into a particular field, but have yet to pinpoint a clinical research study to conduct on campus, we encourage you to schedule a meeting with our Business Development Team today.
A Clinical Research Confidentiality Disclosure Agreement (CDA) is a legally binding document signed between two or more parties involved in clinical research, such as sponsors, contract research organizations (CROs), and academic institutions.
The purpose of a CDA is to protect the confidentiality of proprietary or confidential information shared between the parties during the course of the study. This may include study protocols, data, results, and other sensitive information. A CDA ensures that the parties involved in the clinical research study agree to keep the confidential information private and not disclose it to third parties without prior written consent. A CDA is a critical tool for protecting the intellectual property of the parties involved in clinical research and for maintaining the integrity of the study.
Sponsors and CROs will require the execution of a CDA prior to beginning any activation activities. It is UCI policy that PIs cannot personally sign CDAs. Your assigned Clinical Research Manager (CRM) can facilitate this process with UCI’s legal teams.
Most sponsors and Clinical Research Organizations (CROs) require a site selection process and CCR’s Business Development, Clinical Operations, and Regulatory Teams can assist with this process.
Clinical research site selection is the process of identifying and evaluating potential study sites for the conduct of clinical research studies. The site selection process typically involves a range of factors, including patient population, UCI capabilities and infrastructure, recruitment potential, and regulatory and logistical considerations. The goal of site selection is to identify sites that can successfully enroll and retain study participants, conduct study procedures according to the protocol, and meet regulatory and ethical requirements. Site selection is a critical aspect of clinical trial planning, as the success of the study is often dependent on the performance of the selected sites. The site selection process requires careful consideration and evaluation of multiple factors to ensure the success of the clinical research study.
The UCI IRB is required to review and approve all research involving human subjects. No human research may begin until an UCI IRB exempt confirmation or UCI IRB approval letter is provided.
The UCI-CCR Regulatory Team will help submit your study to the IRB. For more information on the UCI IRB, click here.
Contract negotiation is a critical process that occurs during the pre-award phase of a clinical trial. It involves the negotiation of the terms and conditions of a contract or agreement between the PI and the funding source. The CCR Start-Up Team will facilitate this process for you in collaboration with the UCI Sponsored Projects Administration (SPA) or the UCI Beall Center for Applied Innovation (AI). This process involves understanding the funding source's terms and conditions and ensuring they fit within UCI’s policies and guidelines, identifying negotiable terms (E.g., budget, payment terms, intellectual property rights, publication rights, etc.), and documentation of the finalized clinical trial agreement (CTA).
The CCR Research Finance Unit is fully equipped with both a pre-award and post-award team to ensure proper financial management of your study.
Pre-Award: Once your study enters our activation process, our team can assist with developing a budget that reflects the proposed clinical trial’s cost. The budget should be based on realistic assumptions and account for all necessary expenses, such as, salaries, equipment, supplies, etc. Our team can also assist with negotiating with the funding source to ensure the proposed budget is acceptable and that any budgetary issues are resolved.
Post-Award: This phase occurs after the study has begun. During this phase, CCR can help manage the study funds and ensure all expenses are properly accounted for. Our team will help create an account, manage the budget, track expenses, invoice the sponsor, and distributing funds.
Clinical research coverage analysis is an important component of designing and conducting clinical trials. The CCR start-up team will conduct a comprehensive review of the clinical trial protocol, applicable regulations, and the specific patient population to determine what costs related to the trial will be covered by various parties, such as the sponsor, insurance, and patients.
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.
The CCR Start-up team will help you gather all the important finalized documents related to the study, such as, the protocol, informed consent form(s), contract, and budget. These documents will be carefully reviewed by our team to ensure they are accurate, complete, and consistent with each other. If there are any discrepancies, inconsistencies or errors identified, our team will make corrections to ensure all documents are well aligned.
Once alignment is complete, the CCR Start-up Team submits KR signoff in order to execute the contract and allow the study to open.
A Site Initiation Visit (SIV) is an important step in the initiation of a clinical research study at UCI and the CCR’s Clinical Operations and Regulatory Teams can assist with the preparation and conduct of this visit. The SIV is conducted by the sponsor or contract research organization (CRO) to ensure that the study site is prepared to conduct the study in compliance with the protocol, regulatory requirements, and ethical principles.
During the SIV, the study team provides training on the study protocol, procedures, and documentation, and reviews the study site's infrastructure, equipment, and staffing. The SIV helps ensure that the study is initiated correctly, the study team is properly trained, and all study-related procedures are being carried out according to the protocol and regulatory requirements. The SIV is a critical step in the successful conduct of clinical research studies.
The CCR Clinical Operations Team is comprised of nearly 40 experienced clinical research coordinators (CRCs). CRCs are healthcare professionals responsible for managing the day-to-day operations of clinical research studies. Our experienced team works closely with PIs and other research team members to ensure that all study activities are conducted according to the protocol, regulatory requirements, and ethical principles. Some of the duties of CRCs include recruiting and screening study participants, obtaining informed consent, collecting and managing data, coordinating study visits and procedures, and monitoring participants for adverse events. CRCs play a crucial role in ensuring the success of clinical research studies and in advancing medical knowledge and patient care.
Towards the end of the activation process, your assigned Clinical Research Manager (CRM) will assign a designated CRC to your study.
The CCR Nursing & Laboratory Services Team is comprised of Registered Nurses (RNs), Medical Assistants (MAs), and laboratory specialists with specialized training in clinical research. They provide a wide range of services at both our Medical Center and on-campus clinic locations:
Center for Innovative Health Therapies (Orange): located at the center of the UCI Medical Center (UCIMC) campus across from the main hospital and next to the new outpatient imaging center. This custom-designed and self-contained clinical research space of approximately 5,000 square feet consists of a waiting and reception area, 6 nursing stations, 3 consultation / interview rooms, 2 examination / procedures rooms, 6 treatment / infusion rooms, a 2-station phlebotomy area, 2 medical preparation / clean rooms, laboratory as well as a processing room. The facility has continuously temperature monitored refrigeration which includes -20C freezers, a large -80C freezer, along with liquid nitrogen storage. All areas are interfaced into the Epic electronic medical record (EMR) system with all vital signs, height, weight, infusion pumps, and electrocardiogram readings being ported directly into EMR for review and retrieval.
Hewitt Hall (Irvine): this dedicated clinical research space on the UCI School of Medicine campus, has 4 treatment / infusion rooms, and 3 consultation rooms that were also upgraded with the installation of a mobile Epic EMR system.
All UCI clinical research studies must be recorded on OnCore CTMS, which is a web-based software application designed to support the management of clinical research studies. OnCore CTMS allows users to manage study protocols, budgets, contracts, regulatory compliance, subject enrollment, and data collection, among other aspects of clinical trial management. The software integrates our Epic Electronic Medical Record (EMR) to provide a comprehensive view of study progress and status. OnCore CTMS helps streamline clinical trial operations, improve study quality, and ensure compliance with regulatory requirements.
The UCI-CCR OnCore Support Team can assist with setting up and training you on the system. Contact our OnCore Support Team.
CCR boasts a team of accomplished clinical research experts committed to equipping you with the skills and knowledge required to conduct clinical research studies at UCI. Your designated Clinical Research Manager (CRM) will act as your primary liaison to coordinate with all relevant teams and organize necessary training sessions to ensure the success of your clinical trial. With their extensive experience and expertise, our team will support you throughout the entire clinical research process to help you achieve your research objectives.
CCR's Recruitment Team is dedicated to providing you with comprehensive enrollment support to achieve your accrual goal. Our recruitment support encompasses a range of internal resources, including chart review, recruitment protocols, and honest broker requests, as well as external marketing, advertisement, and outreach initiatives. To kickstart your clinical trial enrollment process, we offer a "Recruitment Kick-Off" meeting before the study's opening, where we can create with you a comprehensive recruitment plan tailored to your study's specific needs. Our goal is to establish an effective recruitment strategy with all stakeholders before the study's commencement, allowing us to hit the ground running from the outset. We welcome requests for additional recruitment meetings throughout the study's enrollment period to revisit or revise the initial recruitment plan to maximize your study's success.