Source:http://linkedlifedata.com/resource/umls/id/C1512516
NCI: A study that has gone beyond the laboratory research and the testing that can be done with experimental animals, and needs to involve humans if it is to be continued at all. Under current law, usually the testing of a new pharmaceutical product or medical device on humans is mandatory. The concept also refers to population-based research in which an investigator directly interacts with individuals.