The Clinical Trial Participant Journey

What to Expect as a Clinical Trial Participant

1. Pre-Screening

First, you will learn about the trial. This may be done via online education, through a contact center, or at an appointment with the local research team. This education usually includes an understanding of you (and if appropriate, your match to the trial), the trial’s purpose, treatment information, potential benefits and risks, the length of your participation, and an overview of the trial’s activities.​

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​2. Informed Consent

You will be provided with a document that details what you need to know as a trial participant so you can make an educated (informed) decision on whether you would like to take part in the trial. The clinical research coordinator will review the document with you and answer any questions you may have. You may want to bring a family member or friend to your appointment to help write down answers to your questions. If you decide to participate in the trial, you will sign the form, which provides your consent and acknowledges your understanding of the risks and your responsibilities. Even if you sign the consent form, you may withdraw from the trial at any time.

3. Screening
The informed consent form covers topics such as:

• Purpose of the research

• Who is eligible to participate

• Expected length of time for participation

• A description of the procedures (exams, tests, etc.) that will be part of the trial

• A description of any expected risks

• Possible discomforts (e.g., injections, frequency of blood tests, etc.)

• Handling of data (e.g., confidentiality, record keeping, FDA inspections)

• Who covers the cost if a clinical trial causes an injury

• Participant rights (e.g., the right to stop participation at any time)

• Who to contact if you have questions

During a participant screening visit, the research team will review your medical history and conduct any other procedures and tests (such as blood work, vitals, body measurements, biopsies, or scans) to make sure you meet all requirements to join the trial.

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​4. Enrollment and Participation

f you qualify, your participation can begin. The research team will provide detailed instructions on what you may need to do at home, how often you will need to visit the trial site, and what will be required at the visits (e.g., physical exams, questionnaires, tests, and procedures). Your overall health and safety are continually monitored for the duration of the trial. Taking part in a trial may require more doctor visits than usual, however many trials offer some reimbursement for your participation.

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​5. End of Trial Participation

Each trial has predefined trial completion criteria. When you complete your trial participation, you may meet with your regular healthcare provider, if different than your research team, to determine further care options. If you are a healthy volunteer, your commitment is over. Keep in mind that researchers can decide to end trials earlier than expected for a variety of reasons. You may also withdraw your consent to participate at any point during the trial.