Before joining a clinical trial, a participant must qualify for the study. All clinical trials have guidelines about who can participate, called inclusion/exclusion criteria. The factors that allow someone to participate in a clinical study are called inclusion criteria, and the factors that disqualify someone from participating in a particular clinical trial are called exclusion criteria.
These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Inclusion and exclusion criteria are not used to reject people personally. Rather, the criteria are used to identify appropriate participants for the study to help the clinical study data answer the questions the researchers are asking.
If you agree to participate in the study, you will be required to sign an Informed Consent Form (ICF). The ICF contains information about the study that your doctor will explain to you so that you can decide whether or not you want to participate in the study.
If you agree to participate in the study, your doctor will have up to 4 weeks to complete the necessary tests to see if you are eligible.