A physical entity ResearchSubject is a participant or object which is the primary unit recipient of operational and/or administrative interest investigative activities in a research study.

Need to make sure we encompass public health studies.

Identifiers assigned to this research subject for a study.

The current publication state of the subject. resource (not of the subject).

The dates the subject began and ended their participation in the study.

Reference to the study the subject is participating in.

The record of the person or person, animal who is or other entity involved in the study.

The name A duration in the lifecycle of the arm ResearchSubject within a ResearchStudy.

Identifies the aspect of this study. the subject's journey that the state refers to.

The date a research subject entered the given state.

The date a research subject exited or left the given state.

The name of reason for the arm state change. If coded it should follow the formal subject state model.

Example, if the milestone is "Randomized" then the reason could be "sponsor IVRS randomization code allocated".

A significant event in the study progress of a ResearchSubject.

A specific event in the research subject's journey through a research study.

The date/time when this milestone event was completed.

A record of rationale that provides additional clarification for the patient's informed agreement milestone that was captured or documented.

A group to participate in which the study. subject is assigned. This group assignment is used for administration or analysis.

This grouping is used for study administration (such as assignment to arms in a trial) or study analysis (such as groupings for observational studies or sensitivity analyses).

Agreement to participate in a study as well as other research agreements, e.g. to acknowledge additional risks, to agree to a protocol deviation, or to agree to more invasive validation subsidies.