ResearchStudy

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.

Properties

Name	Card	Type	Description
id	0..1	string	Logical id of this artifact
meta	0..1	Meta	Metadata about the resource
implicitRules	0..1	uri	A set of rules under which this content was created
language	0..1	code	Language of the resource content
text	0..1	Narrative	Text summary of the resource, for human interpretation
contained	0..*	Resource	Contained, inline Resources
extension	0..*	Extension	Additional content defined by implementations
modifierExtension	0..*	Extension	Extensions that cannot be ignored
identifier	0..*	Identifier	Business Identifier for study
title	0..1	string	Name for this study
protocol	0..*	Reference	Steps followed in executing study
partOf	0..*	Reference	Part of larger study
status	1..1	code	active | administratively-completed | approved | closed-to-accrual |
closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual |
temporarily-closed-to-accrual-and-intervention | withdrawn
primaryPurposeType	0..1	CodeableConcept	treatment | prevention | diagnostic | supportive-care | screening |
health-services-research | basic-science | device-feasibility
phase	0..1	CodeableConcept	n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
category	0..*	CodeableConcept	Classifications for the study
focus	0..*	CodeableConcept	Drugs, devices, etc. under study
condition	0..*	CodeableConcept	Condition being studied
contact	0..*	ContactDetail	Contact details for the study
relatedArtifact	0..*	RelatedArtifact	References and dependencies
keyword	0..*	CodeableConcept	Used to search for the study
location	0..*	CodeableConcept	Geographic region(s) for study
description	0..1	markdown	What this is study doing
enrollment	0..*	Reference	Inclusion & exclusion criteria
period	0..1	Period	When the study began and ended
sponsor	0..1	Reference	Organization that initiates and is legally responsible for the study
principalInvestigator	0..1	Reference	Researcher who oversees multiple aspects of the study
site	0..*	Reference	Facility where study activities are conducted
reasonStopped	0..1	CodeableConcept	accrual-goal-met | closed-due-to-toxicity |
closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
note	0..*	Annotation	Comments made about the study
arm	0..*	BackboneElement	Defined path through the study for a subject
objective	0..*	BackboneElement	A goal for the study

Search Parameters

Name	Type	Description	Expression
category	token	Classifications for the study	ResearchStudy.category
date	date	When the study began and ended	ResearchStudy.period
focus	token	Drugs, devices, etc. under study	ResearchStudy.focus
identifier	token	Business Identifier for study	ResearchStudy.identifier
keyword	token	Used to search for the study	ResearchStudy.keyword
location	token	Geographic region(s) for study	ResearchStudy.location
partof	reference	Part of larger study	ResearchStudy.partOf
principalinvestigator	reference	Researcher who oversees multiple aspects of the study	ResearchStudy.principalInvestigator
protocol	reference	Steps followed in executing study	ResearchStudy.protocol
site	reference	Facility where study activities are conducted	ResearchStudy.site
sponsor	reference	Organization that initiates and is legally responsible for the study	ResearchStudy.sponsor
status	token	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn	ResearchStudy.status
title	string	Name for this study	ResearchStudy.title