http://hl7.org/fhir/StructureDefinition/ResearchStudy|5.0.0
A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.
| Name | Flags | Card | Type | Description & Constraints |
|---|---|---|---|---|
ResearchStudy | 0..* | Investigation to increase healthcare-related patient-independent knowledge | ||
| 0..1 | uri | Canonical identifier for this study resource | ||
Σ | 0..* | Identifier | Business Identifier for study | |
| 0..1 | string | The business version for the study record | ||
| 0..1 | string | Name for this study (computer friendly) | ||
Σ | 0..1 | string | Human readable name of the study | |
| 0..* | BackboneElement | Additional names for the study | ||
| 0..1 | CodeableConcept | primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid TitleType (extensible) | ||
| 0..1 | string | The name | ||
Σ | 0..* | Reference | Steps followed in executing study | |
Σ | 0..* | Reference | Part of larger study | |
| 0..* | RelatedArtifact | References, URLs, and attachments | ||
| 0..1 | dateTime | Date the resource last changed | ||
?!Σ | 1..1 | code | draft | active | retired | unknown PublicationStatus (required) | |
Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility ResearchStudyPrimaryPurposeType (preferred) | |
Σ | 0..1 | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 ResearchStudyPhase (example) | |
Σ | 0..* | CodeableConcept | Classifications of the study design characteristics StudyDesign (preferred) | |
| 0..* | CodeableReference | Drugs, devices, etc. under study ResearchStudyFocusType (example) | ||
Σ | 0..* | CodeableConcept | Condition being studied ConditionCode (example) | |
Σ | 0..* | CodeableConcept | Used to search for the study ResearchStudyKeyword (example) | |
Σ | 0..* | CodeableConcept | Geographic area for the study Jurisdiction (extensible) | |
| 0..1 | markdown | Brief text explaining the study | ||
| 0..1 | markdown | Detailed narrative of the study | ||
Σ | 0..1 | Period | When the study began and ended | |
Σ | 0..* | Reference | Facility where study activities are conducted | |
| 0..* | Annotation | Comments made about the study | ||
| 0..* | CodeableConcept | Classification for the study ResearchStudyClassifiers (example) | ||
| 0..* | BackboneElement | Sponsors, collaborators, and other parties | ||
| 0..1 | string | Name of associated party | ||
| 1..1 | CodeableConcept | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair ResearchStudyPartyRole (extensible) | ||
| 0..* | Period | When active in the role | ||
| 0..* | CodeableConcept | nih | fda | government | nonprofit | academic | industry ResearchStudyPartyOrganizationType (example) | ||
| 0..1 | Reference | Individual or organization associated with study (use practitionerRole to specify their organisation) | ||
| 0..* | BackboneElement | Status of study with time for that status | ||
| 1..1 | CodeableConcept | Label for status or state (e.g. recruitment status) ResearchStudyStudyStatus (extensible) | ||
| 0..1 | boolean | Actual if true else anticipated | ||
| 0..1 | Period | Date range | ||
Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design ResearchStudyReasonStopped (example) | |
Σ | 0..1 | BackboneElement | Target or actual group of participants enrolled in study | |
| 0..1 | unsignedInt | Estimated total number of participants to be enrolled | ||
| 0..1 | unsignedInt | Actual total number of participants enrolled in study | ||
| 0..1 | Reference | Inclusion and exclusion criteria | ||
Σ | 0..1 | Reference | Group of participants who were enrolled in study | |
| 0..* | BackboneElement | Defined path through the study for a subject | ||
| 0..1 | id | Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily | ||
| 1..1 | string | Label for study comparisonGroup | ||
| 0..1 | CodeableConcept | Categorization of study comparisonGroup ResearchStudyArmType (extensible) | ||
| 0..1 | markdown | Short explanation of study path | ||
| 0..* | Reference | Interventions or exposures in this comparisonGroup or cohort | ||
| 0..1 | Reference | Group of participants who were enrolled in study comparisonGroup | ||
| 0..* | BackboneElement | A goal for the study | ||
| 0..1 | string | Label for the objective | ||
| 0..1 | CodeableConcept | primary | secondary | exploratory ResearchStudyObjectiveType (preferred) | ||
| 0..1 | markdown | Description of the objective | ||
| 0..* | BackboneElement | A variable measured during the study | ||
| 0..1 | string | Label for the outcome | ||
| 0..* | CodeableConcept | primary | secondary | exploratory ResearchStudyObjectiveType (preferred) | ||
| 0..1 | markdown | Description of the outcome | ||
| 0..1 | Reference | Structured outcome definition | ||
Σ | 0..* | Reference | Link to results generated during the study |