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Screening Process

Before an individual can enter a clinical trial, especially a Phase I/II study, they must go through a “screening process”.  The screening process helps the study investigator determine if an individual is eligible to participate in a study. The following describes the process of screening potential participants for investigational clinical trials conducted at the Center for Immunization Research (CIR). The CIR uses an IRB approved (H.22.04.02.19.A2) screening protocol to conduct the screening process.

Pre-screening/Phone assessment:  The purpose of the pre-screening/phone assessment is to find out if you are a good candidate to participate in the screening study.  If you’re interested in volunteering, you may call us at 877-863-1374/410-955-7283 or e-mail us at :ProjectSave@jhsph.edu and a study team member will give you information about our studies.

During the phone assessment, we will ask for general information about you, (such as your name, age, and race), your contact information (such as address and phone numbers) as well as information about your general health. We will also ask questions about your current medications, military service, travel history, and past participation in other research studies.

Screening Appointment:  After the pre-screening/phone assessment is complete and if you are eligible to continue, you will be given an appointment date and time to come to the CIR for the first in-person screening visit.  During this visit, we will introduce you to CIR study staff, have you read our screening consent, collect more information about your medical history, evaluate your overall health and determine your eligibility to continue the screening process.  It usually takes two visits to complete the screening process and to determine if you will be eligible for enrollment into an investigational study. We will let you know if any additional visits are needed.

ID Verification: Your identity and date of birth will be verified at this visit.  Please bring acceptable forms of identification with you. Some acceptable forms of identification are a picture ID, government-issued document that has your name and date of birth, driver’s license, state ID and birth certificate.  If you have questions about acceptable forms of identification, you may call the CIR at 410-955-7283 or 877-863-1374.

If at any time during this visit, something is discovered that will exclude you from taking part in a research study, you will be informed.

Consenting Process:  You will be asked to read our screening consent form which outlines the screening process.   If you agree, you will be asked to sign and date the form, giving us permission to evaluate your general health. Once you have read the consent form, you will be asked to complete a quiz to see how well you understood it. This is to make sure that you understand all the major points of the screening study, and to address any parts of the study procedures that need clarification. You will also be given information about HIV testing and the CIR’s code of conduct to review at this time.   

There is a separate consent form for each specific study conducted at the CIR.  If you remain eligible after the first screening visit, you will be asked to return to the CIR to read the consent specific to the study that you are screening for.

Completing Paperwork:  After you have read and signed the consent form and have taken the quiz, you will be asked to complete some paper work. This paper work includes supplying contact information (including your address, phone number, and e-mail address), completing medical history, and reproductive information (females only) forms.

Vital Signs & Review of Medical History:  Once you have completed the paperwork, your vital signs will be measured. This may include your height, weight, temperature, blood pressure, pulse, and rate of breathing.  A staff member will then review the medical history form you completed. 

Specimen Collection: Specimens such as blood and urine may be collected to perform specific laboratory tests.  These tests may vary depending on the screening study.  You will be informed during the consenting process which tests will be done.

Transportation Reimbursement/End of Visit:  Once all the screening activities are complete, you will be provided with MTA tokens (enough for 1 day pass) or a parking validation sticker to cover parking expenses. Parking can be validated at any of our East Baltimore Campus lots, however the Caroline and McElderry parking garages located on Caroline and McElderry Streets are most convenient. You will also be given a return appointment or told that you will be contacted by a study coordinator in order to schedule your next appointment.

To learn more about participating in a vaccine clinical trial, visit our ENROLL now page or you may contact us at (410-955-7283) (toll free 877-863-1374).