How to Start a Clinical Trial

Embarking on a clinical trial is an exciting and significant step in advancing medical research and improving patient care. Whether you're a seasoned researcher or new to the process, understanding the steps involved can be overwhelming. Our goal is to provide you with a clear and comprehensive guide to help you navigate this journey successfully. With our expert team by your side, you'll have access to the support, resources, and guidance needed to start your clinical trial with confidence.

Our process includes clear key steps, essential features for efficiency, and thorough document alignment to ensure your trial's success.

Pre-start-up steps

The steps from our initial communication to “site selection” are outlined below:

  1. Initial communication: Connect with business development by filling out the form below to express your interest in conducting a clinical research study at UCI.
  2. Confidential Disclosure Agreement (CDA): Begin the process by executing a CDA for the study. Your clinical team can facilitate this through the Sponsored Projects Administration (SPA)

    3. Please note: Investigators should never sign a CDA themselves.

  3. Acceptance: Please review and complete the sponsor feasibility questionnaire. Once completed, the sponsor will evaluate the responses and, if they wish to proceed, will issue a "site selection" letter indicating their interest in initiating the study at our site. Following this, both the sponsor and the UCI study team will mutually decide whether to move forward with conducting the study at UCI.
  4. Site Qualification Visit (SQV): Our team will help coordinate a visit to UCI to verify facilities, staff, equipment, and patient population suitability. At this point, you can concur on whether to pursue entering a contract to conduct the study at UCI.
  5. Feasibility Review: Submit essential documents for review (including the study protocol, the informed consent form, study budget template, and initial agreement), triggering the three parallel start-up processes upon approval.

Start-up steps

Once we are “site selected” by the sponsor and have decided to begin the official start-up process at UCI, below is the process that will take us to study activation.

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 we conduct final sign-offs.

The Contract track includes the KR Proposal Process and DocuSign workflow to expedite contract execution:

  clinical trial PI process

 

The UCI IRB reviews and approves all research involving human subjects. Human research may only begin when UCI IRB provides an exempt confirmation or an approval letter. The UCI  team will submit your study to the IRB and update you on the process.

For more details, please review the links below:

Document alignment

Document alignment is a crucial step for you as a Principal Investigator (PI) to ensure that all documents related to your clinical trial are accurate, complete and consistent. This process helps you mitigate financial risk by identifying and correcting any discrepancies, inconsistencies or errors that could impact your study. Once document alignment is complete, our Start-Up Team will submit the Kuali Research (KR) signoff, allowing you to execute the contract and open your study.

 

Contact Our Business Development Team

Thank you for your interest with our team.

One of our specialists will be in contact with you soon.

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