Path | Short | Definition | Comments |
---|---|---|---|
Physical entity which is the primary unit of interest in the study | A physical entity which is the primary unit of operational and/or administrative interest in a study. | Need to make sure we encompass public health studies. | |
identifier | Business Identifier for research subject in a study | Identifiers assigned to this research subject for a study. | |
status | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn | The current state of the subject. | |
period | Start and end of participation | The dates the subject began and ended their participation in the study. | |
study | Study subject is part of | Reference to the study the subject is participating in. | |
individual | Who is part of study | The record of the person or animal who is involved in the study. | |
assignedArm | What path should be followed | The name of the arm in the study the subject is expected to follow as part of this study. | |
actualArm | What path was followed | The name of the arm in the study the subject actually followed as part of this study. | |
consent | Agreement to participate in study | A record of the patient's informed agreement to participate in the study. |
A research subject is the entity of interest in a research study, typically a human being or an animal, but can also be a device, group of humans or animals, or a tissue sample. The ResearchSubject resource describes essential information about the subject, including the gender, birthdate, study, study arm, consent status, and other key items. Human research subjects are usually not traceable to a particular person to protect the subject’s privacy.
The ResearchSubject resource is used in the following research activities:
The following diagram reflects the "typical" state machine for ResearchSubject.
date | Start and end of participation | ResearchSubject.period |
identifier | Business Identifier for research subject in a study | ResearchSubject.identifier |
individual | Who is part of study | ResearchSubject.individual |
patient | Who is part of study | ResearchSubject.individual |
status | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn | ResearchSubject.status |
study | Study subject is part of | ResearchSubject.study |