Release 5 Ballot
TerminologyThis page is part of the FHIR Specification (v5.0.0-ballot: FHIR R5 Ballot Preview). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
Raw Turtle (+ also see Turtle/RDF Format Specification)
Definition for Code SystemResearchStudyClassifiers
@prefix fhir: <http://hl7.org/fhir/> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
# - resource -------------------------------------------------------------------
[] a fhir:CodeSystem;
fhir:Resource.id [ fhir:value "research-study-classifiers"];
fhir:Resource.meta [
fhir:Meta.lastUpdated [ fhir:value "2022-09-07T11:58:29.429+11:00" ];
fhir:Meta.profile [ fhir:value "http://hl7.org/fhir/StructureDefinition/shareablecodesystem" ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ]
];
fhir:DomainResource.extension [
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg" ];
fhir:Extension.value [ fhir:value "brr" ]
], [
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status" ];
fhir:Extension.value [ fhir:value "trial-use" ]
], [
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm" ];
fhir:Extension.value [ fhir:value "0" ]
];
fhir:CanonicalResource.url [ fhir:value "http://hl7.org/fhir/research-study-classifiers"];
fhir:CanonicalResource.identifier [
fhir:Identifier.system [ fhir:value "urn:ietf:rfc:3986" ];
fhir:Identifier.value [ fhir:value "urn:oid:2.16.840.1.113883.4.642.4.1967" ]
];
fhir:CanonicalResource.version [ fhir:value "5.0.0-ballot"];
fhir:CanonicalResource.name [ fhir:value "ResearchStudyClassifiers"];
fhir:CanonicalResource.title [ fhir:value "ResearchStudy Classifiers Code System"];
fhir:CanonicalResource.status [ fhir:value "draft"];
fhir:CanonicalResource.experimental [ fhir:value "false"];
fhir:CanonicalResource.date [ fhir:value "2022-05-15T16:55:11.085+11:00"];
fhir:CanonicalResource.publisher [ fhir:value "HL7 (FHIR Project)"];
fhir:CanonicalResource.contact [
fhir:ContactDetail.telecom [
fhir:ContactPoint.system [ fhir:value "url" ];
fhir:ContactPoint.value [ fhir:value "http://hl7.org/fhir" ]
], [
fhir:ContactPoint.system [ fhir:value "email" ];
fhir:ContactPoint.value [ fhir:value "fhir@lists.hl7.org" ]
]
];
fhir:CanonicalResource.description [ fhir:value "Codes for use in ResearchStudy Resource. This resource (this entire set of content) is being used for active development of a ResearchStudyClassifiers CodeSystem for use for supporting multiple value sets in the FHIR ResearchStudy StructureDefinition."];
fhir:CodeSystem.url [ fhir:value "http://hl7.org/fhir/research-study-classifiers"];
fhir:CodeSystem.identifier [
fhir:Identifier.system [ fhir:value "urn:ietf:rfc:3986" ];
fhir:Identifier.value [ fhir:value "urn:oid:2.16.840.1.113883.4.642.4.1967" ]
];
fhir:CodeSystem.version [ fhir:value "5.0.0-ballot"];
fhir:CodeSystem.name [ fhir:value "ResearchStudyClassifiers"];
fhir:CodeSystem.title [ fhir:value "ResearchStudy Classifiers Code System"];
fhir:CodeSystem.status [ fhir:value "draft"];
fhir:CodeSystem.experimental [ fhir:value "false"];
fhir:CodeSystem.date [ fhir:value "2022-05-15T16:55:11.085+11:00"];
fhir:CodeSystem.publisher [ fhir:value "HL7 (FHIR Project)"];
fhir:CodeSystem.contact [
fhir:ContactDetail.telecom [
fhir:ContactPoint.system [ fhir:value "url" ];
fhir:ContactPoint.value [ fhir:value "http://hl7.org/fhir" ]
], [
fhir:ContactPoint.system [ fhir:value "email" ];
fhir:ContactPoint.value [ fhir:value "fhir@lists.hl7.org" ]
]
];
fhir:CodeSystem.description [ fhir:value "Codes for use in ResearchStudy Resource. This resource (this entire set of content) is being used for active development of a ResearchStudyClassifiers CodeSystem for use for supporting multiple value sets in the FHIR ResearchStudy StructureDefinition."];
fhir:CodeSystem.caseSensitive [ fhir:value "true"];
fhir:CodeSystem.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/research-study-classifiers"];
fhir:CodeSystem.hierarchyMeaning [ fhir:value "is-a"];
fhir:CodeSystem.content [ fhir:value "complete"];
fhir:CodeSystem.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "research-study-prim-purp-type" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Research Study Primary Purpose Type" ];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "treatment" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Treatment" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "One or more interventions are being evaluated for treating a disease, syndrome, or condition." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "prevention" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Prevention" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "One or more interventions are being assessed for preventing the development of a specific disease or health condition." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "diagnostic" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Diagnostic" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "One or more interventions are being evaluated for identifying a disease or health condition." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "supportive-care" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Supportive Care" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "screening" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Screening" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "health-services-research" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Health Services Research" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "basic-science" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Basic Science" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention)." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "device-feasibility" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Device Feasibility" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "An intervention of a device product is being evaluated to determine the feasibility of the product or to test a prototype device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial." ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "research-study-phase" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Research Study Phase" ];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "n-a" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "N/A" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Trials without phases (for example, studies of devices or behavioral interventions)." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "early-phase-1" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Early Phase 1" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Formerly called Phase 0." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "phase-1" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Phase 1" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "phase-1-phase-2" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Phase 1/Phase 2" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Trials that are a combination of phases 1 and 2." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "phase-2" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Phase 2" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "phase-2-phase-3" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Phase 2/Phase 3" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Trials that are a combination of phases 2 and 3." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "phase-3" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Phase 3" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "phase-4" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Phase 4" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use." ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "research-study-focus-type" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Research Study Focus Type" ];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "medication" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Medication" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "device" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Device" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "intervention" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Intervention" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "factor" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Factor" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "research-study-classifier" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Research Study Classifier" ];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "fda-regulated-drug" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "FDA regulated drug" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A medication regulated by the U.S. Food and Drug Administration." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "fda-regulated-device" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "FDA regulated device" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A medical device regulated by the U.S. Food and Drug Administration." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "mpg-paragraph-23b" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "MPG Paragraph 23b" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b)." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "irb-exempt" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "IRB-exempt" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB)." ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "research-study-party-organization-type" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Research Study Party Organization Type" ];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "nih" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "NIH" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "fda" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "FDA" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "government" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Government" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "nonprofit" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Nonprofit" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "academic" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Academic" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "industry" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Industry" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "research-study-party-role" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Research Study Party Role" ];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "sponsor" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Sponsor" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "lead-sponsor" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Lead Sponsor" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "sponsor-investigator" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Sponsor-Investigator" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "primary-investigator" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Primary Investigator" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "collaborator" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Collaborator" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "funding-source" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Funding Source" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "general-contact" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "General Contact" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "recruitment-contact" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Recruitment Contact" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "sub-investigator" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Sub-investigator" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "study-director" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Study Director" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "study-chair" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Study Chair" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "research-study-status" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Research Study Status" ];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "overall-study" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Overall study" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Used for documenting the start and end of the overall study, distinct from progress states." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "active" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Active" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Study is opened for accrual." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "active-but-not-recruiting" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Active, not recruiting" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "administratively-completed" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Administratively Completed" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Study is completed prematurely and will not resume; patients are no longer examined nor treated." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "approved" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Approved" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Protocol is approved by the review board." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "closed-to-accrual" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Closed to Accrual" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Study is closed for accrual; patients can be examined and treated." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "closed-to-accrual-and-intervention" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Closed to Accrual and Intervention" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Study is closed to accrual and intervention, i.e. the study is closed to enrollment, all study subjects have completed treatment or intervention but are still being followed according to the primary objective of the study." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "completed" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Completed" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "The study closed according to the study plan. There will be no further treatments, interventions or data collection." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "disapproved" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Disapproved" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Protocol was disapproved by the review board." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "enrolling-by-invitation" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Enrolling by invitation" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "in-review" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "In Review" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Protocol is submitted to the review board for approval." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "not-yet-recruiting" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Not yet recruiting" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "The study has not started recruiting participants." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "recruiting" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Recruiting" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "The study is currently recruiting participants." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "temporarily-closed-to-accrual" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Temporarily Closed to Accrual" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Study is temporarily closed for accrual; can be potentially resumed in the future; patients can be examined and treated." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "temporarily-closed-to-accrual-and-intervention" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Temporarily Closed to Accrual and Intervention" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Study is temporarily closed for accrual and intervention and potentially can be resumed in the future." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "terminated" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Terminated" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "The study has stopped early and will not start again. Participants are no longer being examined or treated." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "withdrawn" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Withdrawn" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Protocol was withdrawn by the lead organization." ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "research-study-registration-activity" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Research Study Registration Activity" ];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "record-verification" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Record Verification" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Record has been verified." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "primary-outcome-data-collection" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Primary outcome data collection" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "registration-submission" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Registration submission" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "registration-submission-qc" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Registration submission Quality Check" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "registration-posting" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Registration posting" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "results-submission" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Results submission" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "results-submission-qc" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Results submission Quality Check" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "results-posting" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Results posting" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "disposition-submission" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Disposition submission" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "disposition-submission-qc" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Disposition submission Quality Check" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "disposition-posting" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Disposition posting" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "update-submission" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Update submission " ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "update-posting" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Update posting" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "research-study-reason-stopped" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Research Study Reason Stopped" ];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "accrual-goal-met" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Accrual Goal Met" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "The study prematurely ended because the accrual goal was met." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "closed-due-to-toxicity" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Closed due to toxicity" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "The study prematurely ended due to toxicity." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "closed-due-to-lack-of-study-progress" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Closed due to lack of study progress" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "The study prematurely ended due to lack of study progress." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "temporarily-closed-per-study-design" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Temporarily closed per study design" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "The study prematurely ended temporarily per study design." ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "research-study-objective-type" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Research Study Objective Type" ];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "primary" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Primary" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "The main question to be answered, and the one that drives any statistical planning for the study—e.g., calculation of the sample size to provide the appropriate power for statistical testing." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "secondary" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Secondary" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Question to be answered in the study that is of lesser importance than the primary objective." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "exploratory" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Exploratory" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Exploratory questions to be answered in the study." ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "research-study-arm-type" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Research Study Arm Type" ];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "active-comparator" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Active Comparator" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "placebo-comparator" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Placebo Comparator" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "sham-comparator" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Sham Comparator" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "no-intervention" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "No Intervention" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "experimental" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Experimental" ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "other-arm-type" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Other Arm Type" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01000" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Study Design" ];
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fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Case study" ]
]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01022" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Population-based design" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design in which the unit of observation is a population or community. " ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Population study" ]
];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01044" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Ecological design" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design in which the unit of observation is a population or community defined by social relationships or physical surroundings. " ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Ecologic study" ]
]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01027" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Cross sectional data collection " ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which data is collected at a single point in time." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Cross-sectional study" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01028" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Longitudinal data collection" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which data is collected at two or more points in time." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Longitudinal study" ]
];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01018" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Time series design" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A longitudinal data collection which includes a set of time-ordered observations." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Multiple time point comparison" ]
];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01019" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Before and after comparison" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A time series design which includes comparisons of observations before and after an event or exposure." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Before and After design" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Pre-Post Design" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Before-After Comparison" ]
]
]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01045" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Primary data collection" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which the data are recorded and collected during the study for the purpose of the same study." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Study-generated data collection" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01026" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Real world data collection" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which the study data are obtained from a source of data collected during a routine process in the natural environment rather than using a process designed or controlled by the researcher." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "RWD collection" ]
];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01039" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Real world data collection from healthcare records" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Real world data collection from data obtained routinely for a purpose of recording healthcare delivery in a record controlled by a healthcare professional." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "RWD collection from clinical care records" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "RWD from health care records" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "RWD from healthcare delivery records" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Real world data collection from medical records" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01050" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Real world data collection from personal health records" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Real world data collection from data obtained routinely for a purpose of recording data related to personal health in a record controlled by the person, guardian, or caretaker." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Real world data collection from personal care records" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "RWD collection from personal medical records" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01040" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Real world data collection from healthcare financing records" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Real world data collection from data obtained routinely for a purpose of recording healthcare financing." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "RWD collection from healthcare financing records" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01048" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Real world data collection from testing procedures" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Real world data collection from data obtained routinely for a purpose of testing, such as diagnostic testing or screening examination." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "RWD collection from testing procedures" ]
];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01046" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Real world data collection from monitoring procedures" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "Real world data collection from data obtained routinely for a purpose of repeated testing." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "RWD collection from monitoring procedures" ]
]
]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01049" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Secondary data collection from prior research" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which the data are collected from data obtained during a different study than the current study." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01042" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Secondary data collection from a registry" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which the data are collected from a system organized to obtain and maintain uniform data for discovery and analysis, and this system is organized prior to the current study." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01051" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Multisite data collection" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which data are collected from two or more geographic locations." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01086" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Quantitative analysis" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which data are analyzed with mathematical or statistical methods and formulas." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01087" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Qualitative analysis" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which data are analyzed, without primary reliance on mathematical or statistical techniques, by coding and organizing data to provide interpretation or understanding of experiences or hypotheses." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01060" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Blinding of study participants" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which study participants are not informed of their intervention assignment." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Masking of study participants" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01061" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Blinding of intervention providers" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which the people administering the intervention are not informed of the intervention assignment." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Masking of intervention providers" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Blinding of intervention deliverers" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Masking of intervention deliverers" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01062" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Blinding of outcome assessors" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which the people determining the outcome are not informed of the intervention assignment." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Masking of outcome assessors" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01063" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Blinding of data analysts" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which the people managing or processing the data and statistical analysis are not informed of the intervention assignment." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Masking of data analysts" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01064" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Allocation concealment" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design process in which all parties influencing study enrollment and allocation to study groups are unaware of the group assignment for the study participant at the time of enrollment and allocation." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Blinding of randomization assignment" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Masking of randomization assignment" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01043" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Multicentric" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design feature in which two or more institutions are responsible for the conduct of the study." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Multi-institutional study" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Multicenter trial" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Multicenter study" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01052" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Includes patient-reported outcome" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design feature in which one or more outcomes are reported directly from the patient without interpretation by a clinician or researcher." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "PRO" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Includes patient-reported outcomes" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01053" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Includes patient-centered outcome" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design feature in which one or more measures are outcomes that patients directly care about, i.e. outcomes that are directly related to patients' experience of their life." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Includes patient-oriented outcome" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Includes patient-important outcome" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Includes patient-relevant outcome" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Includes clinical outcome" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Includes patient-centered outcome measure" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Includes clinical outcome measure" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01054" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Includes disease-oriented outcome" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design feature in which one or more measures are outcomes that relate to a health or illness condition but are not outcomes which patients directly care about." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Includes disease-oriented outcome measure" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Includes surrogate outcome" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Includes surrogate outcome measure" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01085" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Includes process measure" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design feature in which one or more outcomes are actions or behaviors of a healthcare professional or care team." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Includes process outcome" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Includes process outcome measure" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01089" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Study Goal" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design feature specifying the intent of the study." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Study Aim" ]
];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01096" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Evaluation Goal" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study goal to assess the efficiency, effectiveness, and impact of a given program, process, person or piece of equipment." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Evaluation Study Goal" ]
], [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Evaluation Aim" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01097" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Derivation Goal" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study goal with the intent to generate a predictive algorithm." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Derivation Study Goal" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01098" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Validation Goal" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study goal with the intent to determine the reliability and/or performance of a procedure for a specific predictive, classification, measurement, or communication purpose." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Validation Study Goal" ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01088" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Comparison Goal" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design feature in which the study intent is to compare two or more interventions or exposures." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Comparative Analysis Goal" ]
];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01091" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Comparative Effectiveness Goal" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design feature in which the study intent is to compare two or more interventions with respect to benefits and/or harms." ];
fhir:ConceptDefinitionComponent.concept [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01090" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Comparative Efficacy Goal" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design feature in which the study intent is to compare two or more interventions with respect to effectiveness in ideal conditions." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01092" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Comparative Safety Goal" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study design feature in which the study intent is to compare two or more interventions with respect to harms." ]
]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01093" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Equivalence Goal" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study goal with the intent to compare two or more interventions or exposures and determine that any difference in effects is within a prespecified range representing absence of a meaningful difference." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01094" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Non-inferiority Goal" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study goal with the intent to compare two or more interventions or exposures and determine that any difference in effects is below a prespecified value representing a threshold between a meaningful difference and absence of a meaningful difference." ]
], [
fhir:ConceptDefinitionComponent.code [ fhir:value "SEVCO:01095" ];
fhir:ConceptDefinitionComponent.display [ fhir:value "Superiority Goal" ];
fhir:ConceptDefinitionComponent.definition [ fhir:value "A study goal with the intent to compare two or more interventions or exposures and detect a difference in effects." ];
fhir:ConceptDefinitionComponent.designation [
fhir:ConceptDefinitionDesignationComponent.use [
fhir:Coding.display [ fhir:value "Alternative term" ]
];
fhir:ConceptDefinitionDesignationComponent.value [ fhir:value "Superiority study goal" ]
]
]
]
]
] .
# -------------------------------------------------------------------------------------
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R5 Ballot hl7.fhir.core#5.0.0-ballot generated on Wed, Sep 7, 2022 11:00+1000.
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