This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions
Biomedical Research and Regulation Work Group | Maturity Level: 0 | Trial Use | Security Category: Business | Compartments: No defined compartments |
Detailed Descriptions for the elements in the ResearchStudy resource.
ResearchStudy | |
Element Id | ResearchStudy |
Definition | 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. |
Short Display | Investigation to increase healthcare-related patient-independent knowledge |
Cardinality | 0..* |
Type | DomainResource |
Alternate Names | Clinical Trial; Study |
Summary | false |
Comments | Need to make sure we encompass public health studies. |
ResearchStudy.url | |
Element Id | ResearchStudy.url |
Definition | Canonical identifier for this study resource, represented as a globally unique URI. |
Short Display | Canonical identifier for this study resource |
Cardinality | 0..1 |
Type | uri |
Summary | false |
ResearchStudy.identifier | |
Element Id | ResearchStudy.identifier |
Definition | Identifiers assigned to this research study by the sponsor or other systems. |
Short Display | Business Identifier for study |
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.version | |
Element Id | ResearchStudy.version |
Definition | The business version for the study record. |
Short Display | The business version for the study record |
Note | This is a business versionId, not a resource version id (see discussion) |
Cardinality | 0..1 |
Type | string |
Summary | false |
ResearchStudy.name | |
Element Id | ResearchStudy.name |
Definition | Name for this study (computer friendly). |
Short Display | Name for this study (computer friendly) |
Cardinality | 0..1 |
Type | string |
Summary | false |
ResearchStudy.title | |
Element Id | ResearchStudy.title |
Definition | The human readable name of the research study. |
Short Display | Human readable name of the study |
Cardinality | 0..1 |
Type | string |
Summary | true |
ResearchStudy.label | |
Element Id | ResearchStudy.label |
Definition | Additional names for the study. |
Short Display | Additional names for the study |
Cardinality | 0..* |
Summary | false |
ResearchStudy.label.type | |
Element Id | ResearchStudy.label.type |
Definition | Kind of name. |
Short Display | primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid |
Cardinality | 0..1 |
Terminology Binding | Title Type (Extensible) |
Type | CodeableConcept |
Summary | false |
ResearchStudy.label.value | |
Element Id | ResearchStudy.label.value |
Definition | The name. |
Short Display | The name |
Cardinality | 0..1 |
Type | string |
Summary | false |
ResearchStudy.protocol | |
Element Id | ResearchStudy.protocol |
Definition | The set of steps expected to be performed as part of the execution of the study. |
Short Display | Steps followed in executing 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. |
Short Display | Part of larger study |
Cardinality | 0..* |
Type | Reference(ResearchStudy) |
Hierarchy | This reference is part of a strict Hierarchy |
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.relatedArtifact | |
Element Id | ResearchStudy.relatedArtifact |
Definition | Citations, references, URLs and other related documents. When using relatedArtifact to share URLs, the relatedArtifact.type will often be set to one of "documentation" or "supported-with" and the URL value will often be in relatedArtifact.document.url but another possible location is relatedArtifact.resource when it is a canonical URL. |
Short Display | References, URLs, and attachments |
Cardinality | 0..* |
Type | RelatedArtifact |
Summary | false |
ResearchStudy.date | |
Element Id | ResearchStudy.date |
Definition | The date (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes. |
Short Display | Date the resource last changed |
Cardinality | 0..1 |
Type | dateTime |
Summary | false |
ResearchStudy.status | |
Element Id | ResearchStudy.status |
Definition | The publication state of the resource (not of the study). |
Short Display | draft | active | retired | unknown |
Cardinality | 1..1 |
Terminology Binding | PublicationStatus (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 activities. A classification of the intent of the study. |
Short Display | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility |
Cardinality | 0..1 |
Terminology Binding | Research Study Primary Purpose Type (Preferred) |
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. |
Short Display | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 |
Cardinality | 0..1 |
Terminology Binding | Research Study Phase (Example) |
Type | CodeableConcept |
Summary | true |
ResearchStudy.studyDesign | |
Element Id | ResearchStudy.studyDesign |
Definition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. |
Short Display | Classifications of the study design characteristics |
Cardinality | 0..* |
Terminology Binding | Study Design (Preferred) |
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. |
Short Display | Drugs, devices, etc. under study |
Cardinality | 0..* |
Terminology Binding | Research Study Focus Type (Example) |
Type | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable) |
Summary | false |
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. |
Short Display | Condition being studied |
Cardinality | 0..* |
Terminology Binding | Condition/Problem/Diagnosis Codes (Example) |
Type | CodeableConcept |
Summary | true |
ResearchStudy.keyword | |
Element Id | ResearchStudy.keyword |
Definition | Key terms to aid in searching for or filtering the study. |
Short Display | Used to search for the study |
Cardinality | 0..* |
Terminology Binding | ResearchStudyKeyword: |
Type | CodeableConcept |
Summary | true |
ResearchStudy.region | |
Element Id | ResearchStudy.region |
Definition | A country, state or other area where the study is taking place rather than its precise geographic location or address. |
Short Display | Geographic area for the study |
Cardinality | 0..* |
Terminology Binding | Jurisdiction ValueSet (Extensible) |
Type | CodeableConcept |
Summary | true |
ResearchStudy.descriptionSummary | |
Element Id | ResearchStudy.descriptionSummary |
Definition | A brief text for explaining the study. |
Short Display | Brief text explaining the study |
Cardinality | 0..1 |
Type | markdown |
Summary | false |
ResearchStudy.description | |
Element Id | ResearchStudy.description |
Definition | A detailed and human-readable narrative of the study. E.g., study abstract. |
Short Display | Detailed narrative of the study |
Cardinality | 0..1 |
Type | markdown |
Summary | false |
ResearchStudy.period | |
Element Id | ResearchStudy.period |
Definition | Identifies the start date and the expected (or actual, depending on status) end date for the study. |
Short Display | When the study began and ended |
Cardinality | 0..1 |
Type | Period |
Alternate Names | timing |
Summary | true |
ResearchStudy.site | |
Element Id | ResearchStudy.site |
Definition | A facility in which study activities are conducted. |
Short Display | Facility where study activities are conducted |
Cardinality | 0..* |
Type | Reference(Location | ResearchStudy | Organization) |
Summary | true |
ResearchStudy.note | |
Element Id | ResearchStudy.note |
Definition | Comments made about the study by the performer, subject or other participants. |
Short Display | Comments made about the study |
Cardinality | 0..* |
Type | Annotation |
Summary | false |
ResearchStudy.classifier | |
Element Id | ResearchStudy.classifier |
Definition | Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource. |
Short Display | Classification for the study |
Cardinality | 0..* |
Terminology Binding | Research Study Classifiers (Example) |
Type | CodeableConcept |
Summary | false |
ResearchStudy.associatedParty | |
Element Id | ResearchStudy.associatedParty |
Definition | Sponsors, collaborators, and other parties. |
Short Display | Sponsors, collaborators, and other parties |
Cardinality | 0..* |
Requirements | While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles. |
Summary | false |
Comments | For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided. |
ResearchStudy.associatedParty.name | |
Element Id | ResearchStudy.associatedParty.name |
Definition | Name of associated party. |
Short Display | Name of associated party |
Cardinality | 0..1 |
Type | string |
Summary | false |
ResearchStudy.associatedParty.role | |
Element Id | ResearchStudy.associatedParty.role |
Definition | Type of association. |
Short Display | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair |
Cardinality | 1..1 |
Terminology Binding | Research Study Party Role (Extensible) |
Type | CodeableConcept |
Summary | false |
ResearchStudy.associatedParty.period | |
Element Id | ResearchStudy.associatedParty.period |
Definition | Identifies the start date and the end date of the associated party in the role. |
Short Display | When active in the role |
Cardinality | 0..* |
Type | Period |
Summary | false |
Comments | The cardinality is 0..* due to the fact that an associated party may be intermittently active in a given role over multiple time periods. |
ResearchStudy.associatedParty.classifier | |
Element Id | ResearchStudy.associatedParty.classifier |
Definition | A categorization other than role for the associated party. |
Short Display | nih | fda | government | nonprofit | academic | industry |
Cardinality | 0..* |
Terminology Binding | Research Study Party Organization Type (Example) |
Type | CodeableConcept |
Summary | false |
ResearchStudy.associatedParty.party | |
Element Id | ResearchStudy.associatedParty.party |
Definition | Individual or organization associated with study (use practitionerRole to specify their organisation). |
Short Display | Individual or organization associated with study (use practitionerRole to specify their organisation) |
Cardinality | 0..1 |
Type | Reference(Practitioner | PractitionerRole | Organization) |
Summary | false |
Comments | Suggestions of a better attribute name are appreciated |
ResearchStudy.progressStatus | |
Element Id | ResearchStudy.progressStatus |
Definition | Status of study with time for that status. |
Short Display | Status of study with time for that status |
Cardinality | 0..* |
Summary | false |
ResearchStudy.progressStatus.state | |
Element Id | ResearchStudy.progressStatus.state |
Definition | Label for status or state (e.g. recruitment status). |
Short Display | Label for status or state (e.g. recruitment status) |
Cardinality | 1..1 |
Terminology Binding | Research Study Status (Extensible) |
Type | CodeableConcept |
Summary | false |
ResearchStudy.progressStatus.actual | |
Element Id | ResearchStudy.progressStatus.actual |
Definition | An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date. |
Short Display | Actual if true else anticipated |
Cardinality | 0..1 |
Type | boolean |
Summary | false |
ResearchStudy.progressStatus.period | |
Element Id | ResearchStudy.progressStatus.period |
Definition | Date range. |
Short Display | Date range |
Cardinality | 0..1 |
Type | Period |
Summary | false |
ResearchStudy.whyStopped | |
Element Id | ResearchStudy.whyStopped |
Definition | A description and/or code explaining the premature termination of the study. |
Short Display | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design |
Cardinality | 0..1 |
Terminology Binding | Research Study Reason Stopped (Example) |
Type | CodeableConcept |
Summary | true |
ResearchStudy.recruitment | |
Element Id | ResearchStudy.recruitment |
Definition | Target or actual group of participants enrolled in study. |
Short Display | Target or actual group of participants enrolled in study |
Cardinality | 0..1 |
Summary | true |
ResearchStudy.recruitment.targetNumber | |
Element Id | ResearchStudy.recruitment.targetNumber |
Definition | Estimated total number of participants to be enrolled. |
Short Display | Estimated total number of participants to be enrolled |
Cardinality | 0..1 |
Type | unsignedInt |
Summary | false |
ResearchStudy.recruitment.actualNumber | |
Element Id | ResearchStudy.recruitment.actualNumber |
Definition | Actual total number of participants enrolled in study. |
Short Display | Actual total number of participants enrolled in study |
Cardinality | 0..1 |
Type | unsignedInt |
Summary | false |
ResearchStudy.recruitment.eligibility | |
Element Id | ResearchStudy.recruitment.eligibility |
Definition | Inclusion and exclusion criteria. |
Short Display | Inclusion and exclusion criteria |
Cardinality | 0..1 |
Type | Reference(Group | EvidenceVariable) |
Summary | false |
ResearchStudy.recruitment.actualGroup | |
Element Id | ResearchStudy.recruitment.actualGroup |
Definition | Group of participants who were enrolled in study. |
Short Display | Group of participants who were enrolled in study |
Cardinality | 0..1 |
Type | Reference(Group) |
Summary | true |
ResearchStudy.comparisonGroup | |
Element Id | ResearchStudy.comparisonGroup |
Definition | Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}. |
Short Display | Defined path through the study for a subject |
Cardinality | 0..* |
Alternate Names | arm |
Summary | false |
Comments | In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups. |
ResearchStudy.comparisonGroup.linkId | |
Element Id | ResearchStudy.comparisonGroup.linkId |
Definition | Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily. |
Short Display | Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily |
Cardinality | 0..1 |
Type | id |
Summary | false |
ResearchStudy.comparisonGroup.name | |
Element Id | ResearchStudy.comparisonGroup.name |
Definition | Unique, human-readable label for this comparisonGroup of the study. |
Short Display | Label for study comparisonGroup |
Cardinality | 1..1 |
Type | string |
Summary | false |
ResearchStudy.comparisonGroup.type | |
Element Id | ResearchStudy.comparisonGroup.type |
Definition | Categorization of study comparisonGroup, e.g. experimental, active comparator, placebo comparater. |
Short Display | Categorization of study comparisonGroup |
Cardinality | 0..1 |
Terminology Binding | Research Study Arm Type (Extensible) |
Type | CodeableConcept |
Summary | false |
ResearchStudy.comparisonGroup.description | |
Element Id | ResearchStudy.comparisonGroup.description |
Definition | A succinct description of the path through the study that would be followed by a subject adhering to this comparisonGroup. |
Short Display | Short explanation of study path |
Cardinality | 0..1 |
Type | markdown |
Summary | false |
ResearchStudy.comparisonGroup.intendedExposure | |
Element Id | ResearchStudy.comparisonGroup.intendedExposure |
Definition | Interventions or exposures in this comparisonGroup or cohort. |
Short Display | Interventions or exposures in this comparisonGroup or cohort |
Cardinality | 0..* |
Type | Reference(EvidenceVariable) |
Requirements | this is necessary for ClinicalTrials.gov use which relates 1 to many interventions to comparisonGroups (aka arms) |
Summary | false |
ResearchStudy.comparisonGroup.observedGroup | |
Element Id | ResearchStudy.comparisonGroup.observedGroup |
Definition | Group of participants who were enrolled in study comparisonGroup. |
Short Display | Group of participants who were enrolled in study comparisonGroup |
Cardinality | 0..1 |
Type | Reference(Group) |
Requirements | This is necessary to relate comparisonGroups to actual groups |
Summary | false |
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. |
Short Display | A goal for the study |
Cardinality | 0..* |
Summary | false |
ResearchStudy.objective.name | |
Element Id | ResearchStudy.objective.name |
Definition | Unique, human-readable label for this objective of the study. |
Short Display | Label for the objective |
Cardinality | 0..1 |
Type | string |
Summary | false |
ResearchStudy.objective.type | |
Element Id | ResearchStudy.objective.type |
Definition | The kind of study objective. |
Short Display | primary | secondary | exploratory |
Cardinality | 0..1 |
Terminology Binding | Research Study Objective Type (Preferred) |
Type | CodeableConcept |
Summary | false |
ResearchStudy.objective.description | |
Element Id | ResearchStudy.objective.description |
Definition | Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description). |
Short Display | Description of the objective |
Cardinality | 0..1 |
Type | markdown |
Summary | false |
ResearchStudy.outcomeMeasure | |
Element Id | ResearchStudy.outcomeMeasure |
Definition | An "outcome measure", "endpoint", "effect measure" or "measure of effect" is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. |
Short Display | A variable measured during the study |
Cardinality | 0..* |
Summary | false |
Comments | A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP |
ResearchStudy.outcomeMeasure.name | |
Element Id | ResearchStudy.outcomeMeasure.name |
Definition | Label for the outcome. |
Short Display | Label for the outcome |
Cardinality | 0..1 |
Type | string |
Summary | false |
ResearchStudy.outcomeMeasure.type | |
Element Id | ResearchStudy.outcomeMeasure.type |
Definition | The parameter or characteristic being assessed as one of the values by which the study is assessed. |
Short Display | primary | secondary | exploratory |
Cardinality | 0..* |
Terminology Binding | Research Study Objective Type (Preferred) |
Type | CodeableConcept |
Summary | false |
ResearchStudy.outcomeMeasure.description | |
Element Id | ResearchStudy.outcomeMeasure.description |
Definition | Description of the outcome. |
Short Display | Description of the outcome |
Cardinality | 0..1 |
Type | markdown |
Summary | false |
ResearchStudy.outcomeMeasure.reference | |
Element Id | ResearchStudy.outcomeMeasure.reference |
Definition | Structured outcome definition. |
Short Display | Structured outcome definition |
Cardinality | 0..1 |
Type | Reference(EvidenceVariable) |
Summary | false |
ResearchStudy.result | |
Element Id | ResearchStudy.result |
Definition | Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov. |
Short Display | Link to results generated during the study |
Cardinality | 0..* |
Type | Reference(Citation | Composition | DiagnosticReport) |
Summary | true |