What to expect in a clinical trial

At UCI Health, we prioritize your privacy, security and safety when you participate in a clinical trial. Below are the typical steps you will follow when participating in one of our studies.

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Clinical trial process Pre-screening for a clinical trial Informed consent Screening process Clinical trial enrollment Clinical assessments Optional extension or open-label study Follow-up period

Clinical trial process

These are the typical steps you will follow when participating in one of our studies.

clinical trial phases

Pre-screening for a clinical trial

To participate in a trial, you will need to meet a specific list of requirements. To determine if you meet these requirements, you will start with a pre-screening process.

During the pre-screening, your clinician or other team members will ask you basic questions to see if you are eligible.

If you meet these initial requirements, you will move into the next stage of the process, informed consent. After you provide consent, you will undergo the official screening process before we enroll you in the trial.

In some cases, researchers may request consent before pre-screening.

Informed consent

Once the team determines you are a candidate for the trial, we will give you all the information you need to make an informed decision. We will answer your questions and discuss:

  • Detailed information about the study
  • Study goals
  • Expectations of your participation
  • Risks, Benefits, & Alternatives

After we review these details, we will give you a consent form and other necessary documents which further explain the clinical trial.

Screening process

The next step is the official screening process to make sure you’re a good candidate for the study. This typically includes:

  • Exams (e.g., physical, neurological, psychological, etc)
  • Blood, urine, and pregnancy tests
  • Medical history and health status questionnaires
  • Vital sign measurements (e.g., blood pressure, heart rate)
  • Medications you take (e.g., pills, injections, infusions)
  • Other tests, such as imaging

Clinical trial enrollment

Once you have qualified for the clinical trial, we will enroll you in the study.

As you start the trial, your research team will walk you through what you can expect each step of the way. They will explain:

  • How long the trial will last
  • How often you will come in for appointments
  • Procedures and assessments you will complete throughout the study
  • Other study logistics

Clinical assessments

Depending on the design and goals of the study in which you are enrolled, you may need any of these common tests and exams along the way:

  • Physical exams
  • Blood/urine tests
  • Imaging (e.g., X-Ray, CT scan, MRI)
  • Electrocardiogram (ECG)
  • Biopsy
  • Medical history and health status questionnaires
  • Vital sign measurements (e.g., blood pressure, heart rate)
  • Symptom or side effect monitoring
  • Cognitive or psychological assessments

These assessments allow us to keep an eye on your health and quality of life throughout the study. They also help our researchers understand the therapy’s safety, effectiveness, and potential side effects.

Optional extension or open-label study

While most clinical trials have set end dates, you may have an option to continue with the trial.

An optional extension helps evaluate the long-term safety and efficacy of the trial. This is particularly important if you are in a trial to help you manage a chronic condition.

An extension also offers you an opportunity to continue receiving the treatment under investigation. Or, if you were originally in a placebo group for the study, you can choose to receive the investigational therapy.

Follow-up period

After you complete the trial, our team will often ask you to return to UCI Health to provide our researchers with additional information.

This follow-up period will occur at different times, ranging from weeks to years after you have completed the trial. During these follow-up visits, our team will ask you questions and perform assessments to determine how you are doing.

This may include:

  • Physical exams
  • Blood tests
  • Other tests to assess your response to treatment

Contact Our Recruitment 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