DEFINITION:<br/>A research project whose objectives are to test or confirm hypotheses concerning the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic.  <br/><br/>EXAMPLE(S):<br/>A vaccine therapy study looking at treating patients with previously treated stage II-III HER2-positive breast cancer<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The comprehensive notion of a study is represented in BRIDG by the classes Study, StudyProtocol, StudyProtocolVersion, StudyProtocolDocument, StudyProtocolDocumentVersion, StudyConduct and all their associations.<br/>- The Study class represents the core concept from a clinician’s perspective and functions technically as an anchor or entry point for all the related concepts and aspects that may be considered characteristics of a study. The study protocol may be of any type that involves subjects, including prevention, therapeutic, interventional or observational. <br/>- The StudyProtocol class represents the plan for the study which includes characteristics and planned activities which can be distilled into or abstracted from a version of the study protocol document and can exist even before the information is put into document form. <br/>- The StudyProtocolVersion class represents the details of the study protocol that may change over time. <br/>- The StudyProtocolDocument class represents the study protocol in a textual, possibly graphical, and human-readable form and is a grouping of the various study protocol document versions. <br/>- The StudyProtocolDocumentVersion class represents the document form of the study protocol version and is contains the details of the study protocol document as they exist[ed] at a particular point in time. <br/>- The StudyConduct class represents the execution of a study based on a study protocol definition which includes the scheduled and performed activities that are subject-specific as well as study-level and site-level activities.<br/>- Each of these main classes may have other associations and attributes that further detail out aspects of the overall study.<br/>