The Informed Consent describes the nature of the study and the experimental drug, any tests or medical exams that are part of the study, and possible benefits and risks to you as a study participant. The Informed Consent will tell you that as a study participant you are a volunteer and have the right to leave the clinical trial at any time, for any reason. It will also provide you with information on who to contact if you have questions or concerns related to the study. Throughout the course of the clinical trial you should feel free to ask questions. Remember, any decision regarding your health is an important decision.
All clinical trials follow strict scientific guidelines.
These guidelines are outlined in the clinical trial protocol. The protocol contains a description of the study's goals, how the new drug will be taken, who will be included in the study, what medical tests will be done, and what data will be collected. Each research center participating in the study center uses the same protocol to help make sure that the information collected from all the centers can be combined and compared. Clinical trials are usually done in three phases. I studies investigate the drug's safety and are conducted with a small number of healthy volunteers.