blob: c94c4449a18151448593cdcc63b6f1d231df9825 [file] [log] [blame]
/**
*/
package org.hl7.fhir;
import org.eclipse.emf.common.util.EList;
/**
* <!-- begin-user-doc -->
* A representation of the model object '<em><b>Research Study</b></em>'.
* <!-- end-user-doc -->
*
* <!-- begin-model-doc -->
* 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.
* If the element is present, it must have either a @value, an @id, or extensions
* <!-- end-model-doc -->
*
* <p>
* The following features are supported:
* </p>
* <ul>
* <li>{@link org.hl7.fhir.ResearchStudy#getIdentifier <em>Identifier</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getTitle <em>Title</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getProtocol <em>Protocol</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getPartOf <em>Part Of</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getStatus <em>Status</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getPrimaryPurposeType <em>Primary Purpose Type</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getPhase <em>Phase</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getCategory <em>Category</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getFocus <em>Focus</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getCondition <em>Condition</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getContact <em>Contact</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getRelatedArtifact <em>Related Artifact</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getKeyword <em>Keyword</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getLocation <em>Location</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getDescription <em>Description</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getEnrollment <em>Enrollment</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getPeriod <em>Period</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getSponsor <em>Sponsor</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getPrincipalInvestigator <em>Principal Investigator</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getSite <em>Site</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getReasonStopped <em>Reason Stopped</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getNote <em>Note</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getArm <em>Arm</em>}</li>
* <li>{@link org.hl7.fhir.ResearchStudy#getObjective <em>Objective</em>}</li>
* </ul>
*
* @see org.hl7.fhir.FhirPackage#getResearchStudy()
* @model extendedMetaData="name='ResearchStudy' kind='elementOnly'"
* @generated
*/
public interface ResearchStudy extends DomainResource {
/**
* Returns the value of the '<em><b>Identifier</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.Identifier}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* Identifiers assigned to this research study by the sponsor or other systems.
* <!-- end-model-doc -->
* @return the value of the '<em>Identifier</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Identifier()
* @model containment="true"
* extendedMetaData="kind='element' name='identifier' namespace='##targetNamespace'"
* @generated
*/
EList<Identifier> getIdentifier();
/**
* Returns the value of the '<em><b>Title</b></em>' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* A short, descriptive user-friendly label for the study.
* <!-- end-model-doc -->
* @return the value of the '<em>Title</em>' containment reference.
* @see #setTitle(org.hl7.fhir.String)
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Title()
* @model containment="true"
* extendedMetaData="kind='element' name='title' namespace='##targetNamespace'"
* @generated
*/
org.hl7.fhir.String getTitle();
/**
* Sets the value of the '{@link org.hl7.fhir.ResearchStudy#getTitle <em>Title</em>}' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* @param value the new value of the '<em>Title</em>' containment reference.
* @see #getTitle()
* @generated
*/
void setTitle(org.hl7.fhir.String value);
/**
* Returns the value of the '<em><b>Protocol</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.Reference}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* The set of steps expected to be performed as part of the execution of the study.
* <!-- end-model-doc -->
* @return the value of the '<em>Protocol</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Protocol()
* @model containment="true"
* extendedMetaData="kind='element' name='protocol' namespace='##targetNamespace'"
* @generated
*/
EList<Reference> getProtocol();
/**
* Returns the value of the '<em><b>Part Of</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.Reference}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* A larger research study of which this particular study is a component or step.
* <!-- end-model-doc -->
* @return the value of the '<em>Part Of</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_PartOf()
* @model containment="true"
* extendedMetaData="kind='element' name='partOf' namespace='##targetNamespace'"
* @generated
*/
EList<Reference> getPartOf();
/**
* Returns the value of the '<em><b>Status</b></em>' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* The current state of the study.
* <!-- end-model-doc -->
* @return the value of the '<em>Status</em>' containment reference.
* @see #setStatus(ResearchStudyStatus)
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Status()
* @model containment="true" required="true"
* extendedMetaData="kind='element' name='status' namespace='##targetNamespace'"
* @generated
*/
ResearchStudyStatus getStatus();
/**
* Sets the value of the '{@link org.hl7.fhir.ResearchStudy#getStatus <em>Status</em>}' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* @param value the new value of the '<em>Status</em>' containment reference.
* @see #getStatus()
* @generated
*/
void setStatus(ResearchStudyStatus value);
/**
* Returns the value of the '<em><b>Primary Purpose Type</b></em>' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* The type of study based upon the intent of the study's activities. A classification of the intent of the study.
* <!-- end-model-doc -->
* @return the value of the '<em>Primary Purpose Type</em>' containment reference.
* @see #setPrimaryPurposeType(CodeableConcept)
* @see org.hl7.fhir.FhirPackage#getResearchStudy_PrimaryPurposeType()
* @model containment="true"
* extendedMetaData="kind='element' name='primaryPurposeType' namespace='##targetNamespace'"
* @generated
*/
CodeableConcept getPrimaryPurposeType();
/**
* Sets the value of the '{@link org.hl7.fhir.ResearchStudy#getPrimaryPurposeType <em>Primary Purpose Type</em>}' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* @param value the new value of the '<em>Primary Purpose Type</em>' containment reference.
* @see #getPrimaryPurposeType()
* @generated
*/
void setPrimaryPurposeType(CodeableConcept value);
/**
* Returns the value of the '<em><b>Phase</b></em>' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
* <!-- end-model-doc -->
* @return the value of the '<em>Phase</em>' containment reference.
* @see #setPhase(CodeableConcept)
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Phase()
* @model containment="true"
* extendedMetaData="kind='element' name='phase' namespace='##targetNamespace'"
* @generated
*/
CodeableConcept getPhase();
/**
* Sets the value of the '{@link org.hl7.fhir.ResearchStudy#getPhase <em>Phase</em>}' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* @param value the new value of the '<em>Phase</em>' containment reference.
* @see #getPhase()
* @generated
*/
void setPhase(CodeableConcept value);
/**
* Returns the value of the '<em><b>Category</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.CodeableConcept}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
* <!-- end-model-doc -->
* @return the value of the '<em>Category</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Category()
* @model containment="true"
* extendedMetaData="kind='element' name='category' namespace='##targetNamespace'"
* @generated
*/
EList<CodeableConcept> getCategory();
/**
* Returns the value of the '<em><b>Focus</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.CodeableConcept}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
* <!-- end-model-doc -->
* @return the value of the '<em>Focus</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Focus()
* @model containment="true"
* extendedMetaData="kind='element' name='focus' namespace='##targetNamespace'"
* @generated
*/
EList<CodeableConcept> getFocus();
/**
* Returns the value of the '<em><b>Condition</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.CodeableConcept}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* 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.
* <!-- end-model-doc -->
* @return the value of the '<em>Condition</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Condition()
* @model containment="true"
* extendedMetaData="kind='element' name='condition' namespace='##targetNamespace'"
* @generated
*/
EList<CodeableConcept> getCondition();
/**
* Returns the value of the '<em><b>Contact</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.ContactDetail}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* Contact details to assist a user in learning more about or engaging with the study.
* <!-- end-model-doc -->
* @return the value of the '<em>Contact</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Contact()
* @model containment="true"
* extendedMetaData="kind='element' name='contact' namespace='##targetNamespace'"
* @generated
*/
EList<ContactDetail> getContact();
/**
* Returns the value of the '<em><b>Related Artifact</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.RelatedArtifact}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* Citations, references and other related documents.
* <!-- end-model-doc -->
* @return the value of the '<em>Related Artifact</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_RelatedArtifact()
* @model containment="true"
* extendedMetaData="kind='element' name='relatedArtifact' namespace='##targetNamespace'"
* @generated
*/
EList<RelatedArtifact> getRelatedArtifact();
/**
* Returns the value of the '<em><b>Keyword</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.CodeableConcept}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* Key terms to aid in searching for or filtering the study.
* <!-- end-model-doc -->
* @return the value of the '<em>Keyword</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Keyword()
* @model containment="true"
* extendedMetaData="kind='element' name='keyword' namespace='##targetNamespace'"
* @generated
*/
EList<CodeableConcept> getKeyword();
/**
* Returns the value of the '<em><b>Location</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.CodeableConcept}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* Indicates a country, state or other region where the study is taking place.
* <!-- end-model-doc -->
* @return the value of the '<em>Location</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Location()
* @model containment="true"
* extendedMetaData="kind='element' name='location' namespace='##targetNamespace'"
* @generated
*/
EList<CodeableConcept> getLocation();
/**
* Returns the value of the '<em><b>Description</b></em>' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* A full description of how the study is being conducted.
* <!-- end-model-doc -->
* @return the value of the '<em>Description</em>' containment reference.
* @see #setDescription(Markdown)
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Description()
* @model containment="true"
* extendedMetaData="kind='element' name='description' namespace='##targetNamespace'"
* @generated
*/
Markdown getDescription();
/**
* Sets the value of the '{@link org.hl7.fhir.ResearchStudy#getDescription <em>Description</em>}' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* @param value the new value of the '<em>Description</em>' containment reference.
* @see #getDescription()
* @generated
*/
void setDescription(Markdown value);
/**
* Returns the value of the '<em><b>Enrollment</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.Reference}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".
* <!-- end-model-doc -->
* @return the value of the '<em>Enrollment</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Enrollment()
* @model containment="true"
* extendedMetaData="kind='element' name='enrollment' namespace='##targetNamespace'"
* @generated
*/
EList<Reference> getEnrollment();
/**
* Returns the value of the '<em><b>Period</b></em>' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* Identifies the start date and the expected (or actual, depending on status) end date for the study.
* <!-- end-model-doc -->
* @return the value of the '<em>Period</em>' containment reference.
* @see #setPeriod(Period)
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Period()
* @model containment="true"
* extendedMetaData="kind='element' name='period' namespace='##targetNamespace'"
* @generated
*/
Period getPeriod();
/**
* Sets the value of the '{@link org.hl7.fhir.ResearchStudy#getPeriod <em>Period</em>}' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* @param value the new value of the '<em>Period</em>' containment reference.
* @see #getPeriod()
* @generated
*/
void setPeriod(Period value);
/**
* Returns the value of the '<em><b>Sponsor</b></em>' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* An organization that initiates the investigation and is legally responsible for the study.
* <!-- end-model-doc -->
* @return the value of the '<em>Sponsor</em>' containment reference.
* @see #setSponsor(Reference)
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Sponsor()
* @model containment="true"
* extendedMetaData="kind='element' name='sponsor' namespace='##targetNamespace'"
* @generated
*/
Reference getSponsor();
/**
* Sets the value of the '{@link org.hl7.fhir.ResearchStudy#getSponsor <em>Sponsor</em>}' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* @param value the new value of the '<em>Sponsor</em>' containment reference.
* @see #getSponsor()
* @generated
*/
void setSponsor(Reference value);
/**
* Returns the value of the '<em><b>Principal Investigator</b></em>' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* 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.
* <!-- end-model-doc -->
* @return the value of the '<em>Principal Investigator</em>' containment reference.
* @see #setPrincipalInvestigator(Reference)
* @see org.hl7.fhir.FhirPackage#getResearchStudy_PrincipalInvestigator()
* @model containment="true"
* extendedMetaData="kind='element' name='principalInvestigator' namespace='##targetNamespace'"
* @generated
*/
Reference getPrincipalInvestigator();
/**
* Sets the value of the '{@link org.hl7.fhir.ResearchStudy#getPrincipalInvestigator <em>Principal Investigator</em>}' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* @param value the new value of the '<em>Principal Investigator</em>' containment reference.
* @see #getPrincipalInvestigator()
* @generated
*/
void setPrincipalInvestigator(Reference value);
/**
* Returns the value of the '<em><b>Site</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.Reference}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* A facility in which study activities are conducted.
* <!-- end-model-doc -->
* @return the value of the '<em>Site</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Site()
* @model containment="true"
* extendedMetaData="kind='element' name='site' namespace='##targetNamespace'"
* @generated
*/
EList<Reference> getSite();
/**
* Returns the value of the '<em><b>Reason Stopped</b></em>' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* A description and/or code explaining the premature termination of the study.
* <!-- end-model-doc -->
* @return the value of the '<em>Reason Stopped</em>' containment reference.
* @see #setReasonStopped(CodeableConcept)
* @see org.hl7.fhir.FhirPackage#getResearchStudy_ReasonStopped()
* @model containment="true"
* extendedMetaData="kind='element' name='reasonStopped' namespace='##targetNamespace'"
* @generated
*/
CodeableConcept getReasonStopped();
/**
* Sets the value of the '{@link org.hl7.fhir.ResearchStudy#getReasonStopped <em>Reason Stopped</em>}' containment reference.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* @param value the new value of the '<em>Reason Stopped</em>' containment reference.
* @see #getReasonStopped()
* @generated
*/
void setReasonStopped(CodeableConcept value);
/**
* Returns the value of the '<em><b>Note</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.Annotation}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* Comments made about the study by the performer, subject or other participants.
* <!-- end-model-doc -->
* @return the value of the '<em>Note</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Note()
* @model containment="true"
* extendedMetaData="kind='element' name='note' namespace='##targetNamespace'"
* @generated
*/
EList<Annotation> getNote();
/**
* Returns the value of the '<em><b>Arm</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.ResearchStudyArm}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* 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.
* <!-- end-model-doc -->
* @return the value of the '<em>Arm</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Arm()
* @model containment="true"
* extendedMetaData="kind='element' name='arm' namespace='##targetNamespace'"
* @generated
*/
EList<ResearchStudyArm> getArm();
/**
* Returns the value of the '<em><b>Objective</b></em>' containment reference list.
* The list contents are of type {@link org.hl7.fhir.ResearchStudyObjective}.
* <!-- begin-user-doc -->
* <!-- end-user-doc -->
* <!-- begin-model-doc -->
* 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.
* <!-- end-model-doc -->
* @return the value of the '<em>Objective</em>' containment reference list.
* @see org.hl7.fhir.FhirPackage#getResearchStudy_Objective()
* @model containment="true"
* extendedMetaData="kind='element' name='objective' namespace='##targetNamespace'"
* @generated
*/
EList<ResearchStudyObjective> getObjective();
} // ResearchStudy