April 18, 2017
The sponsoring organization is the entity with primary responsibility for initiating and conducting the studies to be registered. When a clinical study is conducted under a U.S. Food and Drug Administration (FDA) investigational new drug application (IND) or investigational device exemption (IDE), the IND or IDE holder is considered the sponsor. When a clinical study is not conducted under an IND or IDE, the organization who initiates the study, by preparing and/or planning the study, and who has authority and control over the study, is considered the sponsor.
Note: "Responsible party" means with respect to a clinical study, the sponsor (or sponsor-investigator) of the clinical study, as defined in 21 CFR 50.3; or the principal investigator of such clinical study if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the study, has access to and control over the data from the clinical study, has the right to publish the results of the study, and has the ability to meet all of the requirements for the submission of clinical study information.