Starting a study at the UCI Center for Clinical Research (CCR)

The CCR Business Development, Start-up and Regulatory Affairs teams ensure that your trial is activated efficiently and effectively. Our high-performance teams aim to activate all clinical trials within 90 to 120 days.

Please see the diagram below for a visual representation of the UCI Center for Clinical Research clinical trial start-up process.

start up process for sponsors

 

Our sponsor process

CCR specialists will guide you through the process, from executing confidentiality disclosure agreements (CDAs) to identifying a Principal Investigator (PI) at UCI.

To begin the start-up process, your team will need to submit all essential documents to the appropriate Clinical Trial Unit (CTU) team, including:
  • the study protocol
  • the informed consent form
  • the study budget template
  • the initial contract agreement

Once all essential documents are submitted, our clock officially starts. Your trial then undergoes review by our Internal Feasibility Committee (IFC), which meets weekly. Once approved, it's time to get started.

Learn more about UCI Center for Clinical Research

Our services

At UCI Center for Clinical Research (CCR), we understand that each clinical research project has unique needs that require personalized attention. Our goal is to advance medical discovery by offering a unique set of services that meet the specific needs of each project, whether it's a first-in-human study or a post-marketing clinical trial for a well-identified candidate for a specific condition.

We offer key functional capabilities in clinical operations, nursing services, regulatory affairs, research finance, and OnCore support/data analytics for Phase 2 and 3 studies. We also specialize in the end-to-end clinical development cycle, including conducting post-marketing Phase 4 studies.

We are dedicated to supporting all types of clinical research, from the earliest stages of development to the final stages of post-marketing studies. Our team of experts is committed to providing the necessary resources and support to advance medical discovery and improve patient outcomes.

Contact Us

Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
    researcher listed above will be available to answer your questions.
  • You are being asked to participate in a clinical research potential participant database to identify
    potential clinical research studies you may be eligible for. Participation in this database is voluntary.
    You may choose to skip any question. You may refuse to participate or discontinue your involvement
    at any time without penalty or loss of benefits. You are free to withdraw from this database at any
    time. If you decide to withdraw from this database you should notify the research team
    immediately    .
  • You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health
  • We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.
  • Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.
  • There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.
  • There are no alternative procedures available. The only alternative is not to participate in this study.
  • There is no compensation for your participation in this database.
  • There is no cost to you for participation in this database.
  • All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.
  • Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.
  • The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.
  • While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.
  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
  • Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.
  • If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.
  • If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form
  • Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.
What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI