ResearchStudy
SpecializedA 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.
| Path | Card. | Type | Description & Constraints |
|---|---|---|---|
| ResearchStudy | 0..* | — | Investigation to increase healthcare-related patient-independent knowledge |
| .idΣ | 0..1 | String | Logical id of this artifact |
| .metaΣ | 0..1 | Meta | Metadata about the resource |
| .implicitRules?!Σ | 0..1 | uri | A set of rules under which this content was created |
| .language | 0..1 | code | Language of the resource content Bindinglanguages(preferred) |
| .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 |
| .identifierΣ | 0..* | Identifier | Business Identifier for study |
| .titleΣ | 0..1 | string | Name for this study |
| .protocolΣ | 0..* | Reference(PlanDefinition) | Steps followed in executing study |
| .partOfΣ | 0..* | Reference(ResearchStudy) | Part of larger study |
| .status?!Σ | 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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Bindingresearch-study-status(required) |
| .primaryPurposeTypeΣ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Bindingresearch-study-prim-purp-type(extensible) |
| .phaseΣ | 0..1 | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Bindingresearch-study-phase(example) |
| .categoryΣ | 0..* | CodeableConcept | Classifications for the study BindingCodes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.(example) |
| .focusΣ | 0..* | CodeableConcept | Drugs, devices, etc. under study BindingCodes for medications, devices and other interventions.(example) |
| .conditionΣ | 0..* | CodeableConcept | Condition being studied Bindingcondition-code(example) |
| .contactΣ | 0..* | ContactDetail | Contact details for the study |
| .relatedArtifact | 0..* | RelatedArtifact | References and dependencies |
| .keywordΣ | 0..* | CodeableConcept | Used to search for the study BindingWords associated with the study that may be useful in discovery.(example) |
| .locationΣ | 0..* | CodeableConcept | Geographic region(s) for study Bindingjurisdiction(extensible) |
| .description | 0..1 | markdown | What this is study doing |
| .enrollmentΣ | 0..* | Reference(Group) | Inclusion & exclusion criteria |
| .periodΣ | 0..1 | Period | When the study began and ended |
| .sponsorΣ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study |
| .principalInvestigatorΣ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study |
| .siteΣ | 0..* | Reference(Location) | Facility where study activities are conducted |
| .reasonStoppedΣ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Bindingresearch-study-reason-stopped(example) |
| .note | 0..* | Annotation | Comments made about the study |
| .arm | 0..* | BackboneElement | Defined path through the study for a subject |
| .id | 0..1 | String | Unique id for inter-element referencing |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| .name | 1..1 | string | Label for study arm |
| .type | 0..1 | CodeableConcept | Categorization of study arm |
| .description | 0..1 | string | Short explanation of study path |
| .objective | 0..* | BackboneElement | A goal for the study |
| .id | 0..1 | String | Unique id for inter-element referencing |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| .name | 0..1 | string | Label for the objective |
| .type | 0..1 | CodeableConcept | primary | secondary | exploratory Bindingresearch-study-objective-type(preferred) |