Property Name | Type and Description | Existence | Cardinality |
---|---|---|---|
identifier |
List<Identifier>
Identifiers assigned to this research study by the sponsor or other systems.
|
0..1
| 0..*
|
title |
PlainText
A short, descriptive user-friendly label for the study.
|
0..1
| N/A
|
partOf |
List<ResearchStudy>
A larger research study of which this particular study is a component or step.
|
0..1
| 0..*
|
status |
Concept
The current state of the study.
|
0..1
| N/A
|
category |
List<Concept>
Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
|
0..1
| 0..*
|
focus |
List<Concept>
The condition(s), medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
|
0..1
| 0..*
|
contact |
List<ElectronicContact>
Contact details to assist a user in learning more about or engaging with the study.
|
0..1
| 0..*
|
keyword |
List<Concept>
Key terms to aid in searching for or filtering the study.
|
0..1
| 0..*
|
jurisdiction |
List<Concept>
Indicates a country, state or other region where the study is taking place.
|
0..1
| 0..*
|
description |
PlainText
A full description of how the study is being conducted.
|
0..1
| N/A
|
studyPeriod |
IntervalValue<Date>
Identifies the start date and the expected (or actual, depending on status) end date for the study.
|
0..1
| N/A
|
sponsor |
Organization
The organization responsible for the execution of the study.
|
0..1
| N/A
|
principalInvestigator |
Party
Indicates the individual who has primary oversite of the execution of the study.
|
0..1
| N/A
|
site |
List<Location>
Clinic, hospital or other healthcare location that is participating in the study.
|
0..1
| 0..*
|
reasonStopped |
Concept
A description and/or code explaining the premature termination of the study.
|
0..1
| N/A
|
note |
List<Annotation>
Comments made about the event by the performer, subject or other participants.
|
0..1
| 0..*
|
arm |
List<ResearchStudyArm>
Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.
|
0..1
| 0..*
|
archetype_node_id
,
name
,
archetype_details