Intention To Treat
Testing conducted in living animal and human systems.
Non-clinical testing conducted in an artificial environment such as a test tube or culture medium.
Relevant clinical and non-clinical data compiled on the investigational drug, biologic or device being studied.
A medical professional, usually a physician but may also be a nurse, pharmacist or other health care professional, under whose direction an investigational drug is administered or dispensed. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site.
The petition through which a drug sponsor requests the FDA to allow human testing of its drug product.
An independent group of professionals designated to review and approve the clinical protocol, informed consent forms, study advertisements, and patient brochures, to ensure that the study is safe and effective for human participation. It is also the IRB’s responsibility to ensure that the study adheres to regulations of a a [...]
Location of research. Retains ultimate responsibility for human subject regulation compliance.
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.