@medplum/fhirtypes/dist/ResearchStudy.d.ts

Medplum FHIR Type Definitions

/*
 * This is a generated file
 * Do not edit manually.
 */

import { Annotation } from './Annotation';
import { CodeableConcept } from './CodeableConcept';
import { ContactDetail } from './ContactDetail';
import { DiagnosticReport } from './DiagnosticReport';
import { EvidenceVariable } from './EvidenceVariable';
import { Extension } from './Extension';
import { Group } from './Group';
import { Identifier } from './Identifier';
import { Location } from './Location';
import { Meta } from './Meta';
import { Narrative } from './Narrative';
import { Organization } from './Organization';
import { Period } from './Period';
import { PlanDefinition } from './PlanDefinition';
import { Practitioner } from './Practitioner';
import { PractitionerRole } from './PractitionerRole';
import { Reference } from './Reference';
import { RelatedArtifact } from './RelatedArtifact';
import { Resource } from './Resource';

/**
 * A 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.
 */
export interface ResearchStudy {

  /**
   * This is a ResearchStudy resource
   */
  readonly resourceType: 'ResearchStudy';

  /**
   * The logical id of the resource, as used in the URL for the resource.
   * Once assigned, this value never changes.
   */
  id?: string;

  /**
   * 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.
   */
  meta?: Meta;

  /**
   * 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.
   */
  implicitRules?: string;

  /**
   * The base language in which the resource is written.
   */
  language?: string;

  /**
   * 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.
   */
  text?: Narrative;

  /**
   * These resources do not have an independent existence apart from the
   * resource that contains them - they cannot be identified independently,
   * and nor can they have their own independent transaction scope.
   */
  contained?: Resource[];

  /**
   * 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 manageable, 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.
   */
  extension?: Extension[];

  /**
   * 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 and/or the understanding
   * of the containing element's descendants. Usually modifier elements
   * provide negation or qualification. To make the use of extensions safe
   * and manageable, 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).
   */
  modifierExtension?: Extension[];

  /**
   * Identifiers assigned to this research study by the sponsor or other
   * systems.
   */
  identifier?: Identifier[];

  /**
   * Name for this study (computer friendly).
   */
  name?: string;

  /**
   * The human readable name of the research study.
   */
  title?: string;

  /**
   * Additional names for the study.
   */
  label?: ResearchStudyLabel[];

  /**
   * The set of steps expected to be performed as part of the execution of
   * the study.
   */
  protocol?: Reference<PlanDefinition>[];

  /**
   * A larger research study of which this particular study is a component
   * or step.
   */
  partOf?: Reference<ResearchStudy>[];

  /**
   * The current state of the study.
   */
  status: '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';

  /**
   * The type of study based upon the intent of the study's activities. A
   * classification of the intent of the study.
   */
  primaryPurposeType?: CodeableConcept;

  /**
   * The stage in the progression of a therapy from initial experimental
   * use in humans in clinical trials to post-market evaluation.
   */
  phase?: CodeableConcept;

  /**
   * Codes categorizing the type of study such as investigational vs.
   * observational, type of blinding, type of randomization, safety vs.
   * efficacy, etc.
   */
  studyDesign?: CodeableConcept[];

  /**
   * Codes categorizing the type of study such as investigational vs.
   * observational, type of blinding, type of randomization, safety vs.
   * efficacy, etc.
   */
  category?: CodeableConcept[];

  /**
   * The medication(s), food(s), therapy(ies), device(s) or other concerns
   * or interventions that the study is seeking to gain more information
   * about.
   */
  focus?: CodeableConcept[];

  /**
   * 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 &quot;healthy volunteer&quot;, but the target condition code would be
   * a Lupus SNOMED code.
   */
  condition?: CodeableConcept[];

  /**
   * Contact details to assist a user in learning more about or engaging
   * with the study.
   */
  contact?: ContactDetail[];

  /**
   * Citations, references, URLs and other related documents.  When using
   * relatedArtifact to share URLs, the relatedArtifact.type will often be
   * set to one of &quot;documentation&quot; or &quot;supported-with&quot; and the URL value
   * will often be in relatedArtifact.document.url but another possible
   * location is relatedArtifact.resource when it is a canonical URL.
   */
  relatedArtifact?: RelatedArtifact[];

  /**
   * Key terms to aid in searching for or filtering the study.
   */
  keyword?: CodeableConcept[];

  /**
   * Indicates a country, state or other region where the study is taking
   * place.
   */
  location?: CodeableConcept[];

  /**
   * A country, state or other area where the study is taking place rather
   * than its precise geographic location or address.
   */
  region?: CodeableConcept[];

  /**
   * A brief text for explaining the study.
   */
  descriptionSummary?: string;

  /**
   * A detailed and human-readable narrative of the study. E.g., study
   * abstract.
   */
  description?: string;

  /**
   * Reference to a Group that defines the criteria for and quantity of
   * subjects participating in the study.  E.g. &quot; 200 female Europeans
   * between the ages of 20 and 45 with early onset diabetes&quot;.
   */
  enrollment?: Reference<Group>[];

  /**
   * Identifies the start date and the expected (or actual, depending on
   * status) end date for the study.
   */
  period?: Period;

  /**
   * An organization that initiates the investigation and is legally
   * responsible for the study.
   */
  sponsor?: Reference<Organization>;

  /**
   * A researcher in a study who oversees multiple aspects of the study,
   * such as concept development, protocol writing, protocol submission for
   * IRB approval, participant recruitment, informed consent, data
   * collection, analysis, interpretation and presentation.
   */
  principalInvestigator?: Reference<Practitioner | PractitionerRole>;

  /**
   * A facility in which study activities are conducted.
   */
  site?: Reference<Location | ResearchStudy | Organization>[];

  /**
   * A description and/or code explaining the premature termination of the
   * study.
   */
  reasonStopped?: CodeableConcept;

  /**
   * Comments made about the study by the performer, subject or other
   * participants.
   */
  note?: Annotation[];

  /**
   * Describes an expected sequence of events for one of the participants
   * of a study.  E.g. Exposure to drug A, wash-out, exposure to drug B,
   * wash-out, follow-up.
   */
  arm?: ResearchStudyArm[];

  /**
   * 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.
   */
  classifier?: CodeableConcept[];

  /**
   * Sponsors, collaborators, and other parties.
   */
  associatedParty?: ResearchStudyAssociatedParty[];

  /**
   * Status of study with time for that status.
   */
  progressStatus?: ResearchStudyProgressStatus[];

  /**
   * A description and/or code explaining the premature termination of the
   * study.
   */
  whyStopped?: CodeableConcept;

  /**
   * Target or actual group of participants enrolled in study.
   */
  recruitment?: ResearchStudyRecruitment;

  /**
   * 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}.
   */
  comparisonGroup?: ResearchStudyComparisonGroup[];

  /**
   * 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.
   */
  objective?: ResearchStudyObjective[];

  /**
   * An &quot;outcome measure&quot;, &quot;endpoint&quot;, &quot;effect measure&quot; or &quot;measure of
   * effect&quot; 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.
   */
  outcomeMeasure?: ResearchStudyOutcomeMeasure[];

  /**
   * 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.
   */
  result?: Reference<DiagnosticReport>[];
}

/**
 * Describes an expected sequence of events for one of the participants
 * of a study.  E.g. Exposure to drug A, wash-out, exposure to drug B,
 * wash-out, follow-up.
 */
export interface ResearchStudyArm {

  /**
   * Unique id for the element within a resource (for internal references).
   * This may be any string value that does not contain spaces.
   */
  id?: string;

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element. To make the use of extensions
   * safe and manageable, 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.
   */
  extension?: Extension[];

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element and that modifies the
   * understanding of the element in which it is contained and/or the
   * understanding of the containing element's descendants. Usually
   * modifier elements provide negation or qualification. To make the use
   * of extensions safe and manageable, 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.
   * 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).
   */
  modifierExtension?: Extension[];

  /**
   * Unique, human-readable label for this arm of the study.
   */
  name: string;

  /**
   * Categorization of study arm, e.g. experimental, active comparator,
   * placebo comparater.
   */
  type?: CodeableConcept;

  /**
   * A succinct description of the path through the study that would be
   * followed by a subject adhering to this arm.
   */
  description?: string;
}

/**
 * Sponsors, collaborators, and other parties.
 */
export interface ResearchStudyAssociatedParty {

  /**
   * Unique id for the element within a resource (for internal references).
   * This may be any string value that does not contain spaces.
   */
  id?: string;

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element. 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.
   */
  extension?: Extension[];

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element and that modifies the
   * understanding of the element in which it is contained and/or 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 can 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).
   */
  modifierExtension?: Extension[];

  /**
   * Name of associated party.
   */
  name?: string;

  /**
   * Type of association.
   */
  role: CodeableConcept;

  /**
   * Identifies the start date and the end date of the associated party in
   * the role.
   */
  period?: Period[];

  /**
   * A categorization other than role for the associated party.
   */
  classifier?: CodeableConcept[];

  /**
   * Individual or organization associated with study (use practitionerRole
   * to specify their organisation).
   */
  party?: Reference<Practitioner | PractitionerRole | Organization>;
}

/**
 * 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}.
 */
export interface ResearchStudyComparisonGroup {

  /**
   * Unique id for the element within a resource (for internal references).
   * This may be any string value that does not contain spaces.
   */
  id?: string;

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element. 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.
   */
  extension?: Extension[];

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element and that modifies the
   * understanding of the element in which it is contained and/or 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 can 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).
   */
  modifierExtension?: Extension[];

  /**
   * Allows the comparisonGroup for the study and the comparisonGroup for
   * the subject to be linked easily.
   */
  linkId?: string;

  /**
   * Unique, human-readable label for this comparisonGroup of the study.
   */
  name: string;

  /**
   * Categorization of study comparisonGroup, e.g. experimental, active
   * comparator, placebo comparater.
   */
  type?: CodeableConcept;

  /**
   * A succinct description of the path through the study that would be
   * followed by a subject adhering to this comparisonGroup.
   */
  description?: string;

  /**
   * Interventions or exposures in this comparisonGroup or cohort.
   */
  intendedExposure?: Reference<EvidenceVariable>[];

  /**
   * Group of participants who were enrolled in study comparisonGroup.
   */
  observedGroup?: Reference<Group>;
}

/**
 * Additional names for the study.
 */
export interface ResearchStudyLabel {

  /**
   * Unique id for the element within a resource (for internal references).
   * This may be any string value that does not contain spaces.
   */
  id?: string;

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element. 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.
   */
  extension?: Extension[];

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element and that modifies the
   * understanding of the element in which it is contained and/or 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 can 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).
   */
  modifierExtension?: Extension[];

  /**
   * Kind of name.
   */
  type?: CodeableConcept;

  /**
   * The name.
   */
  value?: string;
}

/**
 * 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.
 */
export interface ResearchStudyObjective {

  /**
   * Unique id for the element within a resource (for internal references).
   * This may be any string value that does not contain spaces.
   */
  id?: string;

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element. 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.
   */
  extension?: Extension[];

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element and that modifies the
   * understanding of the element in which it is contained and/or 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 can 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).
   */
  modifierExtension?: Extension[];

  /**
   * Unique, human-readable label for this objective of the study.
   */
  name?: string;

  /**
   * The kind of study objective.
   */
  type?: CodeableConcept;

  /**
   * 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).
   */
  description?: string;
}

/**
 * An &quot;outcome measure&quot;, &quot;endpoint&quot;, &quot;effect measure&quot; or &quot;measure of
 * effect&quot; 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.
 */
export interface ResearchStudyOutcomeMeasure {

  /**
   * Unique id for the element within a resource (for internal references).
   * This may be any string value that does not contain spaces.
   */
  id?: string;

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element. 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.
   */
  extension?: Extension[];

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element and that modifies the
   * understanding of the element in which it is contained and/or 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 can 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).
   */
  modifierExtension?: Extension[];

  /**
   * Label for the outcome.
   */
  name?: string;

  /**
   * The parameter or characteristic being assessed as one of the values by
   * which the study is assessed.
   */
  type?: CodeableConcept[];

  /**
   * Description of the outcome.
   */
  description?: string;

  /**
   * Structured outcome definition.
   */
  reference?: Reference<EvidenceVariable>;
}

/**
 * Status of study with time for that status.
 */
export interface ResearchStudyProgressStatus {

  /**
   * Unique id for the element within a resource (for internal references).
   * This may be any string value that does not contain spaces.
   */
  id?: string;

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element. 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.
   */
  extension?: Extension[];

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element and that modifies the
   * understanding of the element in which it is contained and/or 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 can 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).
   */
  modifierExtension?: Extension[];

  /**
   * Label for status or state (e.g. recruitment status).
   */
  state: CodeableConcept;

  /**
   * 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.
   */
  actual?: boolean;

  /**
   * Date range.
   */
  period?: Period;
}

/**
 * Target or actual group of participants enrolled in study.
 */
export interface ResearchStudyRecruitment {

  /**
   * Unique id for the element within a resource (for internal references).
   * This may be any string value that does not contain spaces.
   */
  id?: string;

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element. 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.
   */
  extension?: Extension[];

  /**
   * May be used to represent additional information that is not part of
   * the basic definition of the element and that modifies the
   * understanding of the element in which it is contained and/or 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 can 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).
   */
  modifierExtension?: Extension[];

  /**
   * Estimated total number of participants to be enrolled.
   */
  targetNumber?: number;

  /**
   * Actual total number of participants enrolled in study.
   */
  actualNumber?: number;

  /**
   * Inclusion and exclusion criteria.
   */
  eligibility?: Reference<Group | EvidenceVariable>;

  /**
   * Group of participants who were enrolled in study.
   */
  actualGroup?: Reference<Group>;
}