About Clinical Research
Clinical research studies are conducted to test investigational medications for treatment of disease and conditions. Studies help determine if investigational medications are safe to use and work to improve people's health. Before any medication can be approved and made available to the public, it has to go through several phases of clinical research.
People participate in clinical research studies for a variety of reasons. Some may participate because they want to learn more about their disease. Others volunteer to participate because they want to help researchers learn more about a disease to potentially help them and others in the future.
Clinical research studies follow a specific set of standards and are closely regulated to help ensure the safety of all participants. Safety precautions are put into place to try and protect people who participate in clinical research. In addition, studies follow a written plan that is called a protocol. The protocol is reviewed by an Institutional Review Board, which is a group of people responsible for protecting the safety and rights of research subjects. Before you participate in any clinical research study, you will review potential risks and benefits, and the study staff will answer any questions you may have.
You can ask questions of the study team at any time before, during, and after the study. Before agreeing to participate, please make sure that you understand the responsibilities of study participants. If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study team at any time.
Study participation is completely voluntary. You do not need to take part in the study, and you can end your participation at any time, for any reason. If you think you would like to stop participating in the study, talk to the study doctor. If you decide you should leave the study early, the study doctor may ask that you return to the study site for a final visit to ensure your health and safety, but there will be no negative impact on the care you receive.
You can visit any doctor to meet your health needs during the study. You should let your study doctor know that you will be seeing another doctor and if any other medication has been prescribed. You should also let your other doctors know that you are participating in a clinical trial.

Answering a few questions can help determine if participating in the Roccella study may be an option for you. If you qualify, the information you provide will be sent to the study site nearest you.

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