Literally, "in glass" or "test tube;" used to refer to processes that are carried out outside the living body, usually in the laboratory, as distinguished from in vivo.
Literally, "in the living body;" processes, such as the absorption of a drug by the human body, carried out in the living body rather than in a laboratory (in vitro).
A process by which a participant or legal guardian voluntarily confirms his or her willingness to participate in a particular research project, after having been informed of all aspects of the research that are relevant to the subject's decision to participate. Informed consent is documented by…
A document that describes the rights of a study participant and provides details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document.
An independent body constituted of medical, scientific, and nonscientific members whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of…
A procedure or treatment such as a drug, nutritional supplement, gene transfer, vaccine, behavior or device modification that is performed for clinical research purposes (45 CFR 46.102(f)). Interventions can also include noninvasive approaches such as surveys, education, and interviews.
A compilation of the clinical and non-clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.