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Biomedical Research and Regulation Work GroupMaturity Level: 0 Trial UseSecurity Category: Business Compartments: Practitioner

Detailed Descriptions for the elements in the ResearchStudy resource.

ResearchStudy
Element IdResearchStudy
Definition

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.

Cardinality0..*
TypeDomainResource
Alternate NamesClinical Trial; Study
Comments

Need to make sure we encompass public health studies.

ResearchStudy.identifier
Element IdResearchStudy.identifier
Definition

Identifiers assigned to this research study by the sponsor or other systems.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Summarytrue
ResearchStudy.title
Element IdResearchStudy.title
Definition

A short, descriptive user-friendly label for the study.

Cardinality0..1
Typestring
Summarytrue
ResearchStudy.protocol
Element IdResearchStudy.protocol
Definition

The set of steps expected to be performed as part of the execution of the study.

Cardinality0..*
TypeReference(PlanDefinition)
Summarytrue
ResearchStudy.partOf
Element IdResearchStudy.partOf
Definition

A larger research study of which this particular study is a component or step.

Cardinality0..*
TypeReference(ResearchStudy)
Requirements

Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.

Alternate Namescontainer
Summarytrue
ResearchStudy.status
Element IdResearchStudy.status
Definition

The current state of the study.

Cardinality1..1
Terminology BindingResearchStudyStatus (Required)
Typecode
Is Modifiertrue (Reason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid)
Summarytrue
ResearchStudy.primaryPurposeType
Element IdResearchStudy.primaryPurposeType
Definition

The type of study based upon the intent of the study's activities. A classification of the intent of the study.

Cardinality0..1
Terminology BindingResearchStudyPrimaryPurposeType (Extensible)
TypeCodeableConcept
Summarytrue
ResearchStudy.phase
Element IdResearchStudy.phase
Definition

The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

Cardinality0..1
Terminology BindingResearchStudyPhase (Example)
TypeCodeableConcept
Summarytrue
ResearchStudy.category
Element IdResearchStudy.category
Definition

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

Cardinality0..*
Terminology BindingResearchStudyCategory:
TypeCodeableConcept
Summarytrue
ResearchStudy.focus
Element IdResearchStudy.focus
Definition

The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.

Cardinality0..*
Terminology BindingResearchStudyFocus:
TypeCodeableConcept
Summarytrue
ResearchStudy.condition
Element IdResearchStudy.condition
Definition

The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.

Cardinality0..*
Terminology BindingCondition/Problem/Diagnosis Codes (Example)
TypeCodeableConcept
Summarytrue
ResearchStudy.contact
Element IdResearchStudy.contact
Definition

Contact details to assist a user in learning more about or engaging with the study.

Cardinality0..*
TypeContactDetail
Summarytrue
ResearchStudy.relatedArtifact
Element IdResearchStudy.relatedArtifact
Definition

Citations, references and other related documents.

Cardinality0..*
TypeRelatedArtifact
ResearchStudy.keyword
Element IdResearchStudy.keyword
Definition

Key terms to aid in searching for or filtering the study.

Cardinality0..*
Terminology BindingResearchStudyKeyword:
TypeCodeableConcept
Summarytrue
ResearchStudy.location
Element IdResearchStudy.location
Definition

Indicates a country, state or other region where the study is taking place.

Cardinality0..*
Terminology BindingJurisdiction (Extensible)
TypeCodeableConcept
Summarytrue
ResearchStudy.description
Element IdResearchStudy.description
Definition

A full description of how the study is being conducted.

Cardinality0..1
Typemarkdown
ResearchStudy.enrollment
Element IdResearchStudy.enrollment
Definition

Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".

Cardinality0..*
TypeReference(Group)
Alternate Namespatient
Summarytrue
Comments

The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.

ResearchStudy.period
Element IdResearchStudy.period
Definition

Identifies the start date and the expected (or actual, depending on status) end date for the study.

Cardinality0..1
TypePeriod
Alternate Namestiming
Summarytrue
ResearchStudy.sponsor
Element IdResearchStudy.sponsor
Definition

An organization that initiates the investigation and is legally responsible for the study.

Cardinality0..1
TypeReference(Organization)
Summarytrue
ResearchStudy.principalInvestigator
Element IdResearchStudy.principalInvestigator
Definition

A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.

Cardinality0..1
TypeReference(Practitioner | PractitionerRole)
PatternsReference(Practitioner,PractitionerRole): Common patterns = Participant
Summarytrue
ResearchStudy.site
Element IdResearchStudy.site
Definition

A facility in which study activities are conducted.

Cardinality0..*
TypeReference(Location)
Summarytrue
ResearchStudy.reasonStopped
Element IdResearchStudy.reasonStopped
Definition

A description and/or code explaining the premature termination of the study.

Cardinality0..1
Terminology BindingResearchStudyReasonStopped (Example)
TypeCodeableConcept
Summarytrue
ResearchStudy.note
Element IdResearchStudy.note
Definition

Comments made about the study by the performer, subject or other participants.

Cardinality0..*
TypeAnnotation
ResearchStudy.arm
Element IdResearchStudy.arm
Definition

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.

Cardinality0..*
ResearchStudy.arm.name
Element IdResearchStudy.arm.name
Definition

Unique, human-readable label for this arm of the study.

Cardinality1..1
Typestring
ResearchStudy.arm.type
Element IdResearchStudy.arm.type
Definition

Categorization of study arm, e.g. experimental, active comparator, placebo comparater.

Cardinality0..1
TypeCodeableConcept
ResearchStudy.arm.description
Element IdResearchStudy.arm.description
Definition

A succinct description of the path through the study that would be followed by a subject adhering to this arm.

Cardinality0..1
Typestring
ResearchStudy.objective
Element IdResearchStudy.objective
Definition

A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.

Cardinality0..*
ResearchStudy.objective.name
Element IdResearchStudy.objective.name
Definition

Unique, human-readable label for this objective of the study.

Cardinality0..1
Typestring
ResearchStudy.objective.type
Element IdResearchStudy.objective.type
Definition

The kind of study objective.

Cardinality0..1
Terminology BindingResearchStudyObjectiveType (Preferred)
TypeCodeableConcept