As a person who is interested in participating in a research study, it is important to know what to expect when participating in a clinical trial. In this blog, we will go over what the first steps are for a person who is interested in being in a clinical trial.
Prescreening & Screening
When a research site is informed of a person that is interested in participating in a clinical study, they will call them by phone. One of the team members will ask a few questions about the person’s medical history, etc., to determine if they meet some of the basic inclusion criteria to possibly participate in the study. This is called a prescreening. If the person passes the prescreen, the team will ask them to come in for a screening visit, which will determine whether it is safe for them to enter into the study.
The very first visit a person will attend is called a screening visit. At this visit, they will read and review an informed consent form (ICF). This form will go over all the information they need to know regarding the study including why they are doing the study, what the study entails, how long the study is, potential risks, compensation they may receive and a few other topics. If they decide they want to continue with the visit to participate in the study after reading the consent, they will sign the consent form. After signing, we will provide them with a copy of the ICF so that they are able to review it at any time. The ICF will provide information about what a person can expect when they attend their screening visit.
During the screening visit, a research coordinator will ask questions regarding medical history, medications being taken, and any specific questions related to the study that may need to be answered. This will be the first time the person meets the study doctor, and they will go over any questions the person may have about the study. They will take your height and weight, temperature, blood pressure, do blood work, and sometimes even do procedures depending on the study, so that we can ensure that it is safe for a person to enter the study. Each study has what is called a screening window. This is the number of days we have to get all of a potential participant’s results back and determine if they are able to enter the study, and the length of the window depends on the study. If everything comes back well, then the participant will be scheduled to come in for an enrollment visit. At the enrollment visit, they will be entered into the study and will be given the study medication/device/therapy.
AIH Ongoing Studies
A screening visit for a clinical trial is very similar to a typical doctor’s office visit! If you ever want to know more about what will happen during a screening visit for a particular study that you are interested in, feel free to contact us and talk to one of our team members! Check out the ongoing studies that we have at AIH!
