Research Policy Term Definition

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(d)) or, under FDA regulations, an activity that (1) involves a drug, other than use of a market drug in the course of medical practice, or (2) the use of a device to evaluate safety and effectiveness of that device, and (3) data from the activity will be submitted to, or held for inspection by, the FDA in support of a marketing or research application for an FDA-regulated product.  If the activity is designed to improve internal practices, it is not research.