CIMI_Clinical.Common

Class ResearchStudy

Documentation:

A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.

Ancestors:

• Locatable
• • NonIndependent
• • • ResearchStudy

Descendants:

Property Summary

Properties

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 the country, state or other region taking legal responsibility for the conduct of the study.	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	EntityOrRole 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> Arm refers to a pre-specified group or subgroup of participants in a clinical trial assigned to receive specific interventions (or no intervention) according to a protocol.	0..1	0..*

Properties inherited from class NonIndependent

Properties inherited from class Locatable

archetype_node_id, name, archetype_details