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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
| Glossary |
An unintended reaction to a drug taken at normal doses. Any untoward medical occurrence in a study subject administered a pharmaceutical product; it does not necessarily have to have a casual relationship with this treatment. The process through which study subjects, the investigator and/or other involved parties in a clinical trial are kept unaware of the treatment assignments of study subjects. The person or entity that assumes, as an independent contractor with the sponsor, one or more of the obligations of the sponsor. Any experiment that involves a test articles (drug, device, biologic) and one or more human subjects. The design of a study in which neither the investigator nor the subject knows which treatment the subject is receiving. The characteristics that must be present (inclusion) or absent (exclusion) in order for a subject to qualify for a clinical trial, as per the protocol for the trial. A new drug or biologic that is used in a clinical investigation. A study in which the subjects and the investigator are aware of the drug that is being administered. An inactive substance designed to resemble the drug being tested. A method in which study subjects are randomly assigned to treatment groups. It helps to reduce bias in a trial by ensuring that there is no pattern in the way subjects are assigned to treatment groups. Any untoward medical occurrence at any dose that results in death, is life-threatening, requires hospitalization (or a prolongation of hospitalization in a patient who is already hospitalized), results in persistent or significant disability or incapacity, or is a congenial anomaly/birth defect. Any member of an investigational team other than the investigator The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial. A group of subjects who are not treated with the investigational product. This group is used as a comparison to the treatment group. An instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis, cure treatment or prevention of disease. A device does not achieve its intended purpose through chemical action in the body and is not dependent upon being metabolized to achieve its purpose. When you agree to participate in a study, you will be asked to sign an Informed Consent Form. The Informed Consent Form provides information about the medication being studied and the specific procedures to be followed during the study. It describes the anticipated effects of the test medication, including current knowledge of its safety and effectiveness. It also includes issues of confidentiality, a statement of treatment alternatives, and a California Subject's Bill of Rights. An individual who actualy conducts a clinical investigation, i.e., under whose immediate direction the test article is dispensed, or, in the case of an investigation conducted by a team of individuals, in the responsible leader of that team. |
| © 2009 Allergy & Asthma Center, PA |