The Process of Volunteering in a Study***
- Pre-Screening Phase:
- You contact us by email (email@example.com) or phone (314-977-6333 or 1-866-410-6333).
- We will ask your age to be sure you are in the correct age group for the study.
- We will send you a consent form by mail, e-mail, or fax. The consent form outlines the details of the study (i.e. risks, benefits, purpose, compensation, etc.).
- After reading the consent form, you may call us back to clarify any questions and/or schedule a screening visit.
- We will answer your questions, review the eligibility criteria to be sure you qualify, and schedule your screening appointment.
- Screening Phase:
- At the beginning of the screening visit, we will review the study consent form with you in detail, answer your questions, and you will sign the consent form. Every effort will be made to help you understand all the details of the study. If there is anything you do not understand about the study, please ask.
- After informed consent is obtained, then the screening visit will continue according to the study’s protocol.
- Enrollment Phase:
- If the results from your screening visit indicate that you qualify for the study, you will be scheduled for an enrollment visit and receive study vaccine. Please note that the screening and enrolling happen on the same visit for some studies.
- Monitoring Phase:
- You will be monitored after joining the study. We typically monitor your body’s protective response through blood samples, and have you keep a personal record of how you feel after receiving study vaccine. Monitoring may require additional visits and/or phone calls to the Center for Vaccine Development