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shr.research

The SHR research domain contains definitions related to the clinical trials and research studies.

Enrollment

Description of the group or groups enrolled or qualified to be enrolled in the study. C4041024

Value:  Group A set of entities (personnel, material, or places) to be considered together. May be a pool of like-type resources, a team, or combination of personnel, material and places.

Jurisdiction

The country, state or other region taking legal responsibility for the conduct of the study.

Value:  CodeableConcept from http://hl7.org/fhir/ValueSet/jurisdiction
(if covered)
A set of codes drawn from different coding systems, representing the same concept.

PrincipalInvestigator

Indicates the individual who has primary oversite of the execution of the study.

Value:  Practitioner A person who practices a healing art.

ResearchSubject [Entry]

Record of a subject's enrollment and participation in a research study.

Based On Entity

Patient required A person in the role of a patient, including extended demographic information about the subject of this health record.
Study required A clinical trial or similar research study. Reference: list of FDA data elements describing a research study: prsinfo.clinicaltrials.gov/definitions.html
Status must be from http://hl7.org/fhir/ValueSet/research-subject-status
required The current standing or state.
ParticipationPeriod required The point in time or span of time the participant is involved.
TerminationReason must be from ResearchSubjectTerminationReasonVS
optional A description and/or code explaining the premature termination of the study.

Sponsor

The organization responsible for the execution of the study.

Value:  Organization A social or legal structure formed by human beings.

Study [Entry]

A clinical trial or similar research study. Reference: list of FDA data elements describing a research study: prsinfo.clinicaltrials.gov/definitions.html

Based On Entity

Title required A distinguishing word or group of words naming an item.
Identifier required A unique string that identifies a specific person or thing.
Details optional An text note containing additional details, explanation, description, comment, or summarization. Details can discuss, support, explain changes to, or dispute information.
PartOf must be a Study
0 or more The larger entity that this is a portion of. For example, an organization might be part of a larger organization, or an encounter with a hospitalist might be part of a larger hospitalization encounter.
Status must be from http://hl7.org/fhir/ValueSet/research-study-status
required The current standing or state.
Enrollment 0 or more Description of the group or groups enrolled or qualified to be enrolled in the study.
EffectiveTimePeriod optional The date and time span for which something is active, valid, or in force.
Sponsor optional The organization responsible for the execution of the study.
Jurisdiction optional The country, state or other region taking legal responsibility for the conduct of the study.
ContactDetail 0 or more Describes an individual and how to reach them.
PrincipalInvestigator optional Indicates the individual who has primary oversite of the execution of the study.
Facility 0 or more Services and space and equipment provided for a particular purpose; a building or place that provides a particular service or is used for a particular industry. Could be a clinical site, community site, or a mobile facility.
TerminationReason optional A description and/or code explaining the premature termination of the study.
Annotation 0 or more An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.
StudyArm 0 or more Arm refers to pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol.

StudyArm

Arm refers to pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol.

Title required A distinguishing word or group of words naming an item.
Type must be from StudyArmTypeVS
optional The most specific code (lowest level term) describing the kind or sort of thing being represented.
Details optional An text note containing additional details, explanation, description, comment, or summarization. Details can discuss, support, explain changes to, or dispute information.

TerminationReason

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

Value:  CodeableConcept A set of codes drawn from different coding systems, representing the same concept.