Release 4 5 Preview #2
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Biomedical Research and Regulation Work Group Maturity Level : 1 0   Trial Use Security Category : Business Compartments : Practitioner

Detailed Descriptions for the elements in the ResearchStudy resource.

ResearchStudy
Element Id ResearchStudy
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.

Cardinality 0..*
Type DomainResource
Alternate Names Clinical Trial; Study
Comments

Need to make sure we encompass public health studies.

ResearchStudy.identifier
Element Id ResearchStudy.identifier
Definition

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

Note This is a business identifier, not a resource identifier (see discussion )
Cardinality 0..*
Type Identifier
Requirements

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

Summary true
ResearchStudy.title
Element Id ResearchStudy.title
Definition

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

Cardinality 0..1
Type string
Summary true
ResearchStudy.protocol
Element Id ResearchStudy.protocol
Definition

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

Cardinality 0..*
Type Reference ( PlanDefinition )
Summary true
ResearchStudy.partOf
Element Id ResearchStudy.partOf
Definition

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

Cardinality 0..*
Type Reference ( ResearchStudy )
Requirements

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

Alternate Names container
Summary true
ResearchStudy.status
Element Id ResearchStudy.status
Definition

The current state of the study.

Cardinality 1..1
Terminology Binding ResearchStudyStatus ( Required )
Type code
Is Modifier true (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)
Summary true
ResearchStudy.primaryPurposeType
Element Id ResearchStudy.primaryPurposeType
Definition

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

Cardinality 0..1
Terminology Binding ResearchStudyPrimaryPurposeType ( Extensible )
Type CodeableConcept
Summary true
ResearchStudy.phase
Element Id ResearchStudy.phase
Definition

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

Cardinality 0..1
Terminology Binding ResearchStudyPhase ( Example )
Type CodeableConcept
Summary true
ResearchStudy.category
Element Id ResearchStudy.category
Definition

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

Cardinality 0..*
Terminology Binding ResearchStudyCategory :
Type CodeableConcept
Summary true
ResearchStudy.focus
Element Id ResearchStudy.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.

Cardinality 0..*
Terminology Binding ResearchStudyFocus :
Type CodeableConcept
Summary true
ResearchStudy.condition
Element Id ResearchStudy.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.

Cardinality 0..*
Terminology Binding Condition/Problem/Diagnosis Codes ( Example )
Type CodeableConcept
Summary true
ResearchStudy.contact
Element Id ResearchStudy.contact
Definition

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

Cardinality 0..*
Type ContactDetail
Summary true
ResearchStudy.relatedArtifact
Element Id ResearchStudy.relatedArtifact
Definition

Citations, references and other related documents.

Cardinality 0..*
Type RelatedArtifact
ResearchStudy.keyword
Element Id ResearchStudy.keyword
Definition

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

Cardinality 0..*
Terminology Binding ResearchStudyKeyword :
Type CodeableConcept
Summary true
ResearchStudy.location
Element Id ResearchStudy.location
Definition

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

Cardinality 0..*
Terminology Binding Jurisdiction ( Extensible )
Type CodeableConcept
Summary true
ResearchStudy.description
Element Id ResearchStudy.description
Definition

A full description of how the study is being conducted.

Cardinality 0..1
Type markdown
ResearchStudy.enrollment
Element Id ResearchStudy.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".

Cardinality 0..*
Type Reference ( Group )
Alternate Names patient
Summary true
Comments

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

ResearchStudy.period
Element Id ResearchStudy.period
Definition

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

Cardinality 0..1
Type Period
Alternate Names timing
Summary true
ResearchStudy.sponsor
Element Id ResearchStudy.sponsor
Definition

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

Cardinality 0..1
Type Reference ( Organization )
Summary true
ResearchStudy.principalInvestigator
Element Id ResearchStudy.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.

Cardinality 0..1
Type Reference ( Practitioner | PractitionerRole )
Patterns Reference(Practitioner,PractitionerRole): Common patterns = Participant
Summary true
ResearchStudy.site
Element Id ResearchStudy.site
Definition

A facility in which study activities are conducted.

Cardinality 0..*
Type Reference ( Location )
Summary true
ResearchStudy.reasonStopped
Element Id ResearchStudy.reasonStopped
Definition

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

Cardinality 0..1
Terminology Binding ResearchStudyReasonStopped ( Example )
Type CodeableConcept
Summary true
ResearchStudy.note
Element Id ResearchStudy.note
Definition

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

Cardinality 0..*
Type Annotation
ResearchStudy.arm
Element Id ResearchStudy.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.

Cardinality 0..*
ResearchStudy.arm.name
Element Id ResearchStudy.arm.name
Definition

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

Cardinality 1..1
Type string
ResearchStudy.arm.type
Element Id ResearchStudy.arm.type
Definition

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

Cardinality 0..1
Type CodeableConcept
ResearchStudy.arm.description
Element Id ResearchStudy.arm.description
Definition

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

Cardinality 0..1
Type string
ResearchStudy.objective
Element Id ResearchStudy.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.

Cardinality 0..*
ResearchStudy.objective.name
Element Id ResearchStudy.objective.name
Definition

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

Cardinality 0..1
Type string
ResearchStudy.objective.type
Element Id ResearchStudy.objective.type
Definition

The kind of study objective.

Cardinality 0..1
Terminology Binding ResearchStudyObjectiveType ( Preferred )
Type CodeableConcept