import { Annotation } from './Annotation.js';
import { Citation } from './Citation.js';
import { CodeableConcept } from './CodeableConcept.js';
import { CodeableReference } from './CodeableReference.js';
import { DiagnosticReport } from './DiagnosticReport.js';
import { EvidenceReport } from './EvidenceReport.js';
import { EvidenceVariable } from './EvidenceVariable.js';
import { Extension } from './Extension.js';
import { FhirPrimitive } from './FhirPrimitive.js';
import { Identifier } from './Identifier.js';
import { Location } from './Location.js';
import { Medication } from './Medication.js';
import { MedicinalProductDefinition } from './MedicinalProductDefinition.js';
import { Meta } from './Meta.js';
import { Narrative } from './Narrative.js';
import { Organization } from './Organization.js';
import { Period } from './Period.js';
import { PlanDefinition } from './PlanDefinition.js';
import { Reference } from './Reference.js';
import { RelatedArtifact } from './RelatedArtifact.js';
import { ResearchStudy_AssociatedParty } from './ResearchStudy_AssociatedParty.js';
import { ResearchStudy_ComparisonGroup } from './ResearchStudy_ComparisonGroup.js';
import { ResearchStudy_Label } from './ResearchStudy_Label.js';
import { ResearchStudy_Objective } from './ResearchStudy_Objective.js';
import { ResearchStudy_OutcomeMeasure } from './ResearchStudy_OutcomeMeasure.js';
import { ResearchStudy_ProgressStatus } from './ResearchStudy_ProgressStatus.js';
import { ResearchStudy_Recruitment } from './ResearchStudy_Recruitment.js';
import { Resource } from './Resource.js';
import { SubstanceDefinition } from './SubstanceDefinition.js';
export interface ResearchStudy {
    /**
     * @description The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
     * @comment Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
     * @short Logical id of this artifact
     */
    id?: string;
    /**
     * @description The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
     * @short Metadata about the resource
     */
    meta?: Meta;
    /**
     * @description A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
     * @comment Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers andor specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
     * @short A set of rules under which this content was created
     */
    implicitRules?: FhirPrimitive<string>;
    /**
     * @description The base language in which the resource is written.
     * @comment Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies  to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
     * @short Language of the resource content
     */
    language?: FhirPrimitive<string>;
    /**
     * @description A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
     * @comment Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
     * @short Text summary of the resource, for human interpretation
     */
    text?: Narrative;
    /**
     * @description These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides contextmeaning.
     * @comment This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.
     * @short Contained, inline Resources
     */
    contained?: Resource[];
    /**
     * @description May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
     * @comment There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
     * @short Additional content defined by implementations
     */
    extension?: Extension[];
    /**
     * @description May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it andor the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
  
  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
     * @comment There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
     * @short Extensions that cannot be ignored
     */
    modifierExtension?: Extension[];
    /**
     * @description Canonical identifier for this study resource, represented as a globally unique URI.
     * @short Canonical identifier for this study resource
     */
    url?: FhirPrimitive<string>;
    /**
     * @description Identifiers assigned to this research study by the sponsor or other systems.
     * @short Business Identifier for study
     */
    identifier?: Identifier[];
    /**
     * @description The business version for the study record.
     * @short The business version for the study record
     */
    version?: FhirPrimitive<string>;
    /**
     * @description Name for this study (computer friendly).
     * @short Name for this study (computer friendly)
     */
    name?: FhirPrimitive<string>;
    /**
     * @description The human readable name of the research study.
     * @short Human readable name of the study
     */
    title?: FhirPrimitive<string>;
    /**
     * @backbone Nested BackboneElement: label [0..*]
     */
    label?: ResearchStudy_Label[];
    /**
     * @description The set of steps expected to be performed as part of the execution of the study.
     * @short Steps followed in executing study
     */
    protocol?: Reference<PlanDefinition>[];
    /**
     * @description A larger research study of which this particular study is a component or step.
     * @short Part of larger study
     */
    partOf?: Reference<ResearchStudy>[];
    /**
     * @description 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 References, URLs, and attachments
     */
    relatedArtifact?: RelatedArtifact[];
    /**
     * @description 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 Date the resource last changed
     */
    date?: FhirPrimitive<string>;
    /**
     * @description The publication state of the resource (not of the study).
     * @short draft | active | retired | unknown
     */
    status: FhirPrimitive<string>;
    /**
     * @description The type of study based upon the intent of the study activities. A classification of the intent of the study.
     * @short treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
     */
    primaryPurposeType?: CodeableConcept;
    /**
     * @description The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
     * @short n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
     */
    phase?: CodeableConcept;
    /**
     * @description Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
     * @short Classifications of the study design characteristics
     */
    studyDesign?: CodeableConcept[];
    /**
     * @description 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 Drugs, devices, etc. under study
     */
    focus?: CodeableReference<Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable>[];
    /**
     * @description 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 Condition being studied
     */
    condition?: CodeableConcept[];
    /**
     * @description Key terms to aid in searching for or filtering the study.
     * @short Used to search for the study
     */
    keyword?: CodeableConcept[];
    /**
     * @description A country, state or other area where the study is taking place rather than its precise geographic location or address.
     * @short Geographic area for the study
     */
    region?: CodeableConcept[];
    /**
     * @description A brief text for explaining the study.
     * @short Brief text explaining the study
     */
    descriptionSummary?: FhirPrimitive<string>;
    /**
     * @description A detailed and human-readable narrative of the study. E.g., study abstract.
     * @short Detailed narrative of the study
     */
    description?: FhirPrimitive<string>;
    /**
     * @description Identifies the start date and the expected (or actual, depending on status) end date for the study.
     * @short When the study began and ended
     */
    period?: Period;
    /**
     * @description A facility in which study activities are conducted.
     * @short Facility where study activities are conducted
     */
    site?: Reference<Location | ResearchStudy | Organization>[];
    /**
     * @description Comments made about the study by the performer, subject or other participants.
     * @short Comments made about the study
     */
    note?: Annotation[];
    /**
     * @description 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 Classification for the study
     */
    classifier?: CodeableConcept[];
    /**
     * @backbone Nested BackboneElement: associatedParty [0..*]
     */
    associatedParty?: ResearchStudy_AssociatedParty[];
    /**
     * @backbone Nested BackboneElement: progressStatus [0..*]
     */
    progressStatus?: ResearchStudy_ProgressStatus[];
    /**
     * @description A description andor code explaining the premature termination of the study.
     * @short accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
     */
    whyStopped?: CodeableConcept;
    /**
     * @backbone Nested BackboneElement: recruitment [0..1]
     */
    recruitment?: ResearchStudy_Recruitment;
    /**
     * @backbone Nested BackboneElement: comparisonGroup [0..*]
     */
    comparisonGroup?: ResearchStudy_ComparisonGroup[];
    /**
     * @backbone Nested BackboneElement: objective [0..*]
     */
    objective?: ResearchStudy_Objective[];
    /**
     * @backbone Nested BackboneElement: outcomeMeasure [0..*]
     */
    outcomeMeasure?: ResearchStudy_OutcomeMeasure[];
    /**
     * @description 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 Link to results generated during the study
     */
    result?: Reference<EvidenceReport | Citation | DiagnosticReport>[];
    /**
     * @const Auto-injected fixed value: ResearchStudy
     */
    resourceType: "ResearchStudy";
}
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