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Class TResearchStudy
Unit
bsFhir_r4
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
Properties
Description
Methods
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constructor Create; override; |
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Properties
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property identifier : TIdentifierArray read GetidentifierArray; |
Identifiers assigned to this research study by the sponsor or other systems.
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property title : string read Gettitle write Settitle; |
A short, descriptive user-friendly label for the study.
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property titleElement : Tstring read GettitleElement write SettitleElement; |
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property protocol : TReferenceArray read GetprotocolArray; |
The set of steps expected to be performed as part of the execution of the study.
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property partOf : TReferenceArray read GetpartOfArray; |
A larger research study of which this particular study is a component or step.
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property status : string read Getstatus write Setstatus; |
The current state of the study.
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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.
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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.
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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.
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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.
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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.
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property contact : TContactDetailArray read GetcontactArray; |
Contact details to assist a user in learning more about or engaging with the study.
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property relatedArtifact : TRelatedArtifactArray read GetrelatedArtifactArray; |
Citations, references and other related documents.
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property keyword : TCodeableConceptArray read GetkeywordArray; |
Key terms to aid in searching for or filtering the study.
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property location : TCodeableConceptArray read GetlocationArray; |
Indicates a country, state or other region where the study is taking place.
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property description : string read Getdescription write Setdescription; |
A full description of how the study is being conducted.
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property descriptionElement : Tmarkdown read GetdescriptionElement write SetdescriptionElement; |
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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".
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property period : TPeriod read Getperiod write Setperiod; |
Identifies the start date and the expected (or actual, depending on status) end date for the study.
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property sponsor : TReference read Getsponsor write Setsponsor; |
An organization that initiates the investigation and is legally responsible for the study.
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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.
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property site : TReferenceArray read GetsiteArray; |
A facility in which study activities are conducted.
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property reasonStopped : TCodeableConcept read GetreasonStopped write SetreasonStopped; |
A description and/or code explaining the premature termination of the study.
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property note : TAnnotationArray read GetnoteArray; |
Comments made about the study by the performer, subject or other participants.
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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.
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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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