What to Expect
This is a general explanation of what you can expect as a potential study participant. Slight differences may vary from office to office.
The first step is getting in touch with a study center to find out if you may qualify for this study. This web site offers information about the study and basic requirements to qualify for the study.
Upon arriving at the office, you will meet the assigned Study Coordinator who will be the main point of contact for the study’s duration. The Study Coordinator will review important study documents with you including the Informed Consent.
Informed Consent explains the key facts about a clinical research study and should be read and understood in its entirety before deciding whether or not to participate. The Study Coordinator will explain the details of the study, as well as the risks and benefits of participating.
Potential study participants (and caregivers, when applicable) will have the chance to ask questions about the study. If a potential study participant decides to participate, he/she will be asked to sign the Informed Consent document, which includes details about the study, such as its purpose, duration, required procedures, and key contacts.
After the Informed Consent has been signed, study-related exams and services will begin either at the same visit or at future scheduled visits. (The study physician, also known as the Principal Investigator or Sub-Investigator, will perform the initial examination.) Additional study visits will be scheduled with the participant and study-specific instructions will be provided.
Additional requirements may be required throughout the course of the study. If these requirements cannot be fulfilled, the participant may no longer qualify and study participation will be stopped. The Study Coordinator will keep in contact with the participant regarding all study-related issues.
Remember, participation is voluntary and participants have the right to withdraw from the study at any time and for any reason, even if the Informed Consent has already been signed.