Study Subject

Definition 1

A matter or an individual that is observed, analyzed, examined, investigated, experimented upon, or/and treated in the course of a particular study. (NCI Thesaurus)

Definition 2

A physical entity which is the primary unit of operational and/or administrative interest in a study. EXAMPLE(S): A person who is registered in a study as a recipient of an investigational product or as a control. Individuals who are being screened for studies. Individuals participating in observational or other studies. A pacemaker, a fuse that can be used in medical devices, a cow, a farm, a pen of pigs, or a tissue sample from a tissue bank. NOTE(S): StudySubjects within a study are all of the same type. An entity registered in a study is not part of another entity registered in the same study. (NCI Thesaurus/BRIDG)

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Study Stopped Reason Code

A coded value specifying why the study has been halted or terminated.

Study Stop Rule

The rule, regulation and/or condition that determines the point in time when a clinical trial will be terminated.

Study Start Time

The time a study began.

Study Start Date

The date on which a study began.

Study Sponsor Type

An attribute used to indicate whether the sponsor assumes an ultimate responsibility for the initiation, management and/or financing of a clinical study,…

Study Sponsor Monitor

An entity that is responsible for overseeing the activities of the study sponsor.