What to Expect When You Volunteer

The exact clinical research trial process depends on the study. Typically, however, the study team of healthcare professionals determines a participant's eligibility, provides instructions for participating in the clinical research trial, carefully monitors participants, and keeps in touch after the clinical research trial is completed.

Determining Eligibility
Before you can participate in a clinical research trial, you will be screened to determine your eligibility. The criteria used to determine whether a person is eligible to participate in a clinical research trial are defined in the study protocol. For example, the I.M.P.A.C.T. clinical research trials require that participants have an accurate diagnosis of HAE. Those with other types of angioedema cannot be part of the study.

• Screening — To determine whether you satisfy the criteria, you'll be asked a series of questions and, if you qualify, you'll undergo screening. During the screening visit, the study coordinator will obtain a full medical history, perform a physical exam, and schedule any necessary laboratory tests.
• Informed Consent — If you are eligible to participate in the study (based on the outcome of screening), the study coordinator will explain the study and the procedures you'll need to follow, and will answer any questions you have. This process is called informed consent and is legally required before you can enroll in a clinical research trial.

Before you enroll in the study, consider your rights and responsibilities as a participant and review your list of questions to make sure that you have all the answers you need.