This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time. Patients considering participating in clinical research should talk about it with their physicians and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study. Clinical Research Terms Clinical Trial A carefully designed investigation of the effects of a drug, medical treatment or device on a group of patients.
Researchers are usually doctors, nurses, pharmacists or other healthcare professionals.
Coordinator This individual manages the clinical trial. All drugs and medical devices must be approved by the FDA before they can be used by the general public. A discussion of all procedures, benefits, risks and expectations of a clinical trial between clinical investigators and potential patients. The FDA requires all patients to sign an informed consent form before participating in a trial. A board consisting of healthcare professionals from the institution where the clinical trials take place, as well as members of the local community.