@medplum/fhirtypes 0.3.0

package/dist/ResearchStudy.d.ts

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+/*
+ * Generated by @medplum/generator
+ * Do not edit manually.
+ */
+
+import { Annotation } from './Annotation';
+import { CodeableConcept } from './CodeableConcept';
+import { ContactDetail } from './ContactDetail';
+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.
+   */
+  readonly 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.
+   */
+  readonly 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.
+   */
+  readonly implicitRules?: string;
+
+  /**
+   * The base language in which the resource is written.
+   */
+  readonly 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.
+   */
+  readonly 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.
+   */
+  readonly 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.
+   */
+  readonly 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).
+   */
+  readonly modifierExtension?: Extension[];
+
+  /**
+   * Identifiers assigned to this research study by the sponsor or other
+   * systems.
+   */
+  readonly identifier?: Identifier[];
+
+  /**
+   * A short, descriptive user-friendly label for the study.
+   */
+  readonly title?: string;
+
+  /**
+   * The set of steps expected to be performed as part of the execution of
+   * the study.
+   */
+  readonly protocol?: Reference<PlanDefinition>[];
+
+  /**
+   * A larger research study of which this particular study is a component
+   * or step.
+   */
+  readonly partOf?: Reference<ResearchStudy>[];
+
+  /**
+   * The current state of the study.
+   */
+  readonly status?: string;
+
+  /**
+   * The type of study based upon the intent of the study's activities. A
+   * classification of the intent of the study.
+   */
+  readonly primaryPurposeType?: CodeableConcept;
+
+  /**
+   * The stage in the progression of a therapy from initial experimental
+   * use in humans in clinical trials to post-market evaluation.
+   */
+  readonly phase?: CodeableConcept;
+
+  /**
+   * Codes categorizing the type of study such as investigational vs.
+   * observational, type of blinding, type of randomization, safety vs.
+   * efficacy, etc.
+   */
+  readonly 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.
+   */
+  readonly 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.
+   */
+  readonly condition?: CodeableConcept[];
+
+  /**
+   * Contact details to assist a user in learning more about or engaging
+   * with the study.
+   */
+  readonly contact?: ContactDetail[];
+
+  /**
+   * Citations, references and other related documents.
+   */
+  readonly relatedArtifact?: RelatedArtifact[];
+
+  /**
+   * Key terms to aid in searching for or filtering the study.
+   */
+  readonly keyword?: CodeableConcept[];
+
+  /**
+   * Indicates a country, state or other region where the study is taking
+   * place.
+   */
+  readonly location?: CodeableConcept[];
+
+  /**
+   * A full description of how the study is being conducted.
+   */
+  readonly 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;.
+   */
+  readonly enrollment?: Reference<Group>[];
+
+  /**
+   * Identifies the start date and the expected (or actual, depending on
+   * status) end date for the study.
+   */
+  readonly period?: Period;
+
+  /**
+   * An organization that initiates the investigation and is legally
+   * responsible for the study.
+   */
+  readonly 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.
+   */
+  readonly principalInvestigator?: Reference<Practitioner | PractitionerRole>;
+
+  /**
+   * A facility in which study activities are conducted.
+   */
+  readonly site?: Reference<Location>[];
+
+  /**
+   * A description and/or code explaining the premature termination of the
+   * study.
+   */
+  readonly reasonStopped?: CodeableConcept;
+
+  /**
+   * Comments made about the study by the performer, subject or other
+   * participants.
+   */
+  readonly 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.
+   */
+  readonly arm?: ResearchStudyArm[];
+
+  /**
+   * 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.
+   */
+  readonly objective?: ResearchStudyObjective[];
+}
+
+/**
+ * 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.
+   */
+  readonly 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.
+   */
+  readonly 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).
+   */
+  readonly modifierExtension?: Extension[];
+
+  /**
+   * Unique, human-readable label for this arm of the study.
+   */
+  readonly name?: string;
+
+  /**
+   * Categorization of study arm, e.g. experimental, active comparator,
+   * placebo comparater.
+   */
+  readonly type?: CodeableConcept;
+
+  /**
+   * A succinct description of the path through the study that would be
+   * followed by a subject adhering to this arm.
+   */
+  readonly description?: 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.
+   */
+  readonly 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.
+   */
+  readonly 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).
+   */
+  readonly modifierExtension?: Extension[];
+
+  /**
+   * Unique, human-readable label for this objective of the study.
+   */
+  readonly name?: string;
+
+  /**
+   * The kind of study objective.
+   */
+  readonly type?: CodeableConcept;
+}

package/dist/ResearchSubject.d.ts

@@ -0,0 +1,142 @@
+/*
+ * Generated by @medplum/generator
+ * Do not edit manually.
+ */
+
+import { Consent } from './Consent';
+import { Extension } from './Extension';
+import { Identifier } from './Identifier';
+import { Meta } from './Meta';
+import { Narrative } from './Narrative';
+import { Patient } from './Patient';
+import { Period } from './Period';
+import { Reference } from './Reference';
+import { ResearchStudy } from './ResearchStudy';
+import { Resource } from './Resource';
+
+/**
+ * A physical entity which is the primary unit of operational and/or
+ * administrative interest in a study.
+ */
+export interface ResearchSubject {
+
+  /**
+   * This is a ResearchSubject resource
+   */
+  readonly resourceType: 'ResearchSubject';
+
+  /**
+   * The logical id of the resource, as used in the URL for the resource.
+   * Once assigned, this value never changes.
+   */
+  readonly 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.
+   */
+  readonly 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.
+   */
+  readonly implicitRules?: string;
+
+  /**
+   * The base language in which the resource is written.
+   */
+  readonly 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.
+   */
+  readonly 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.
+   */
+  readonly 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.
+   */
+  readonly 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).
+   */
+  readonly modifierExtension?: Extension[];
+
+  /**
+   * Identifiers assigned to this research subject for a study.
+   */
+  readonly identifier?: Identifier[];
+
+  /**
+   * The current state of the subject.
+   */
+  readonly status?: string;
+
+  /**
+   * The dates the subject began and ended their participation in the
+   * study.
+   */
+  readonly period?: Period;
+
+  /**
+   * Reference to the study the subject is participating in.
+   */
+  readonly study?: Reference<ResearchStudy>;
+
+  /**
+   * The record of the person or animal who is involved in the study.
+   */
+  readonly individual?: Reference<Patient>;
+
+  /**
+   * The name of the arm in the study the subject is expected to follow as
+   * part of this study.
+   */
+  readonly assignedArm?: string;
+
+  /**
+   * The name of the arm in the study the subject actually followed as part
+   * of this study.
+   */
+  readonly actualArm?: string;
+
+  /**
+   * A record of the patient's informed agreement to participate in the
+   * study.
+   */
+  readonly consent?: Reference<Consent>;
+}