Class TResearchStudy

Unit

Declaration

type TResearchStudy = class(TDomainResource)

Description

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

Hierarchy

Overview

Methods

Public constructor Create; override;

Properties

Public property identifier : TIdentifierArray read GetidentifierArray;
Public property title : string read Gettitle write Settitle;
Public property titleElement : Tstring read GettitleElement write SettitleElement;
Public property protocol : TReferenceArray read GetprotocolArray;
Public property partOf : TReferenceArray read GetpartOfArray;
Public property status : string read Getstatus write Setstatus;
Public property statusElement : TResearchStudyStatus read GetstatusElement write SetstatusElement;
Public property primaryPurposeType : TCodeableConcept read GetprimaryPurposeType write SetprimaryPurposeType;
Public property phase : TCodeableConcept read Getphase write Setphase;
Public property category : TCodeableConceptArray read GetcategoryArray;
Public property focus : TCodeableConceptArray read GetfocusArray;
Public property condition : TCodeableConceptArray read GetconditionArray;
Public property contact : TContactDetailArray read GetcontactArray;
Public property relatedArtifact : TRelatedArtifactArray read GetrelatedArtifactArray;
Public property keyword : TCodeableConceptArray read GetkeywordArray;
Public property location : TCodeableConceptArray read GetlocationArray;
Public property description : string read Getdescription write Setdescription;
Public property descriptionElement : Tmarkdown read GetdescriptionElement write SetdescriptionElement;
Public property enrollment : TReferenceArray read GetenrollmentArray;
Public property period : TPeriod read Getperiod write Setperiod;
Public property sponsor : TReference read Getsponsor write Setsponsor;
Public property principalInvestigator : TReference read GetprincipalInvestigator write SetprincipalInvestigator;
Public property site : TReferenceArray read GetsiteArray;
Public property reasonStopped : TCodeableConcept read GetreasonStopped write SetreasonStopped;
Public property note : TAnnotationArray read GetnoteArray;
Public property arm : TResearchStudyArmArray read GetarmArray;
Public property objective : TResearchStudyObjectiveArray read GetobjectiveArray;

Description

Methods

Public constructor Create; override;
 

Properties

Public property identifier : TIdentifierArray read GetidentifierArray;

Identifiers assigned to this research study by the sponsor or other systems.

Public property title : string read Gettitle write Settitle;

A short, descriptive user-friendly label for the study.

Public property titleElement : Tstring read GettitleElement write SettitleElement;
 
Public property protocol : TReferenceArray read GetprotocolArray;

The set of steps expected to be performed as part of the execution of the study.

Public property partOf : TReferenceArray read GetpartOfArray;

A larger research study of which this particular study is a component or step.

Public property status : string read Getstatus write Setstatus;

The current state of the study.

Public property statusElement : TResearchStudyStatus read GetstatusElement write SetstatusElement;
 
Public property primaryPurposeType : TCodeableConcept read GetprimaryPurposeType write SetprimaryPurposeType;

The type of study based upon the intent of the study's activities. A classification of the intent of the study.

Public property phase : TCodeableConcept read Getphase write Setphase;

The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

Public property category : TCodeableConceptArray read GetcategoryArray;

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

Public property focus : TCodeableConceptArray read GetfocusArray;

The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.

Public property condition : TCodeableConceptArray read GetconditionArray;

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.

Public property contact : TContactDetailArray read GetcontactArray;

Contact details to assist a user in learning more about or engaging with the study.

Public property relatedArtifact : TRelatedArtifactArray read GetrelatedArtifactArray;

Citations, references and other related documents.

Public property keyword : TCodeableConceptArray read GetkeywordArray;

Key terms to aid in searching for or filtering the study.

Public property location : TCodeableConceptArray read GetlocationArray;

Indicates a country, state or other region where the study is taking place.

Public property description : string read Getdescription write Setdescription;

A full description of how the study is being conducted.

Public property descriptionElement : Tmarkdown read GetdescriptionElement write SetdescriptionElement;
 
Public property enrollment : TReferenceArray read GetenrollmentArray;

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".

Public property period : TPeriod read Getperiod write Setperiod;

Identifies the start date and the expected (or actual, depending on status) end date for the study.

Public property sponsor : TReference read Getsponsor write Setsponsor;

An organization that initiates the investigation and is legally responsible for the study.

Public property principalInvestigator : TReference read GetprincipalInvestigator write SetprincipalInvestigator;

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.

Public property site : TReferenceArray read GetsiteArray;

A facility in which study activities are conducted.

Public property reasonStopped : TCodeableConcept read GetreasonStopped write SetreasonStopped;

A description and/or code explaining the premature termination of the study.

Public property note : TAnnotationArray read GetnoteArray;

Comments made about the study by the performer, subject or other participants.

Public property arm : TResearchStudyArmArray read GetarmArray;

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.

Public property objective : TResearchStudyObjectiveArray read GetobjectiveArray;

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.


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