Inclusion and exclusion criteria are the specific characteristics that determine whether an individual is eligible to participate in a clinical trial. Inclusion criteria are the characteristics that an individual must have in order to be eligible to participate in the trial, while exclusion criteria are the characteristics that disqualify an individual from participating in the trial.
Inclusion and exclusion criteria are an important aspect of the clinical trial design, as they help to ensure that the study population is well-defined and representative of the target patient population. They also help to minimize the risks to the participants and to ensure the integrity of the study results.
Some common examples of inclusion criteria for a clinical trial might include:
Some common examples of exclusion criteria for a clinical trial might include:
Inclusion and exclusion criteria are typically specified in the clinical trial protocol, which is a detailed plan that outlines the objectives, design, and conduct of the trial.