Class ResearchStudy.Builder

    • Method Detail

      • id

        public ResearchStudy.Builder id​(String id)
        The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
        Overrides:
        id in class DomainResource.Builder
        Parameters:
        id - Logical id of this artifact
        Returns:
        A reference to this Builder instance
      • meta

        public ResearchStudy.Builder meta​(Meta meta)
        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.
        Overrides:
        meta in class DomainResource.Builder
        Parameters:
        meta - Metadata about the resource
        Returns:
        A reference to this Builder instance
      • implicitRules

        public ResearchStudy.Builder implicitRules​(Uri implicitRules)
        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.
        Overrides:
        implicitRules in class DomainResource.Builder
        Parameters:
        implicitRules - A set of rules under which this content was created
        Returns:
        A reference to this Builder instance
      • language

        public ResearchStudy.Builder language​(Code language)
        The base language in which the resource is written.
        Overrides:
        language in class DomainResource.Builder
        Parameters:
        language - Language of the resource content
        Returns:
        A reference to this Builder instance
      • text

        public ResearchStudy.Builder text​(Narrative text)
        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.
        Overrides:
        text in class DomainResource.Builder
        Parameters:
        text - Text summary of the resource, for human interpretation
        Returns:
        A reference to this Builder instance
      • contained

        public ResearchStudy.Builder contained​(Resource... contained)
        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.

        Adds new element(s) to the existing list

        Overrides:
        contained in class DomainResource.Builder
        Parameters:
        contained - Contained, inline Resources
        Returns:
        A reference to this Builder instance
      • contained

        public ResearchStudy.Builder contained​(Collection<Resource> contained)
        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.

        Replaces the existing list with a new one containing elements from the Collection

        Overrides:
        contained in class DomainResource.Builder
        Parameters:
        contained - Contained, inline Resources
        Returns:
        A reference to this Builder instance
      • extension

        public ResearchStudy.Builder extension​(Extension... extension)
        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.

        Adds new element(s) to the existing list

        Overrides:
        extension in class DomainResource.Builder
        Parameters:
        extension - Additional content defined by implementations
        Returns:
        A reference to this Builder instance
      • extension

        public ResearchStudy.Builder extension​(Collection<Extension> extension)
        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.

        Replaces the existing list with a new one containing elements from the Collection

        Overrides:
        extension in class DomainResource.Builder
        Parameters:
        extension - Additional content defined by implementations
        Returns:
        A reference to this Builder instance
      • modifierExtension

        public ResearchStudy.Builder modifierExtension​(Extension... modifierExtension)
        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).

        Adds new element(s) to the existing list

        Overrides:
        modifierExtension in class DomainResource.Builder
        Parameters:
        modifierExtension - Extensions that cannot be ignored
        Returns:
        A reference to this Builder instance
      • modifierExtension

        public ResearchStudy.Builder modifierExtension​(Collection<Extension> modifierExtension)
        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).

        Replaces the existing list with a new one containing elements from the Collection

        Overrides:
        modifierExtension in class DomainResource.Builder
        Parameters:
        modifierExtension - Extensions that cannot be ignored
        Returns:
        A reference to this Builder instance
      • identifier

        public ResearchStudy.Builder identifier​(Identifier... identifier)
        Identifiers assigned to this research study by the sponsor or other systems.

        Adds new element(s) to the existing list

        Parameters:
        identifier - Business Identifier for study
        Returns:
        A reference to this Builder instance
      • identifier

        public ResearchStudy.Builder identifier​(Collection<Identifier> identifier)
        Identifiers assigned to this research study by the sponsor or other systems.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        identifier - Business Identifier for study
        Returns:
        A reference to this Builder instance
      • title

        public ResearchStudy.Builder title​(String title)
        A short, descriptive user-friendly label for the study.
        Parameters:
        title - Name for this study
        Returns:
        A reference to this Builder instance
      • protocol

        public ResearchStudy.Builder protocol​(Reference... protocol)
        The set of steps expected to be performed as part of the execution of the study.

        Adds new element(s) to the existing list

        Parameters:
        protocol - Steps followed in executing study
        Returns:
        A reference to this Builder instance
      • protocol

        public ResearchStudy.Builder protocol​(Collection<Reference> protocol)
        The set of steps expected to be performed as part of the execution of the study.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        protocol - Steps followed in executing study
        Returns:
        A reference to this Builder instance
      • partOf

        public ResearchStudy.Builder partOf​(Reference... partOf)
        A larger research study of which this particular study is a component or step.

        Adds new element(s) to the existing list

        Parameters:
        partOf - Part of larger study
        Returns:
        A reference to this Builder instance
      • partOf

        public ResearchStudy.Builder partOf​(Collection<Reference> partOf)
        A larger research study of which this particular study is a component or step.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        partOf - Part of larger study
        Returns:
        A reference to this Builder instance
      • status

        public ResearchStudy.Builder status​(ResearchStudyStatus status)
        The current state of the study.

        This element is required.

        Parameters:
        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
        Returns:
        A reference to this Builder instance
      • primaryPurposeType

        public ResearchStudy.Builder primaryPurposeType​(CodeableConcept primaryPurposeType)
        The type of study based upon the intent of the study's activities. A classification of the intent of the study.
        Parameters:
        primaryPurposeType - treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device- feasibility
        Returns:
        A reference to this Builder instance
      • phase

        public ResearchStudy.Builder phase​(CodeableConcept phase)
        The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
        Parameters:
        phase - n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
        Returns:
        A reference to this Builder instance
      • category

        public ResearchStudy.Builder category​(CodeableConcept... category)
        Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

        Adds new element(s) to the existing list

        Parameters:
        category - Classifications for the study
        Returns:
        A reference to this Builder instance
      • category

        public ResearchStudy.Builder category​(Collection<CodeableConcept> category)
        Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        category - Classifications for the study
        Returns:
        A reference to this Builder instance
      • focus

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

        Adds new element(s) to the existing list

        Parameters:
        focus - Drugs, devices, etc. under study
        Returns:
        A reference to this Builder instance
      • focus

        public ResearchStudy.Builder focus​(Collection<CodeableConcept> focus)
        The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        focus - Drugs, devices, etc. under study
        Returns:
        A reference to this Builder instance
      • condition

        public ResearchStudy.Builder condition​(CodeableConcept... condition)
        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.

        Adds new element(s) to the existing list

        Parameters:
        condition - Condition being studied
        Returns:
        A reference to this Builder instance
      • condition

        public ResearchStudy.Builder condition​(Collection<CodeableConcept> condition)
        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.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        condition - Condition being studied
        Returns:
        A reference to this Builder instance
      • contact

        public ResearchStudy.Builder contact​(ContactDetail... contact)
        Contact details to assist a user in learning more about or engaging with the study.

        Adds new element(s) to the existing list

        Parameters:
        contact - Contact details for the study
        Returns:
        A reference to this Builder instance
      • contact

        public ResearchStudy.Builder contact​(Collection<ContactDetail> contact)
        Contact details to assist a user in learning more about or engaging with the study.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        contact - Contact details for the study
        Returns:
        A reference to this Builder instance
      • relatedArtifact

        public ResearchStudy.Builder relatedArtifact​(RelatedArtifact... relatedArtifact)
        Citations, references and other related documents.

        Adds new element(s) to the existing list

        Parameters:
        relatedArtifact - References and dependencies
        Returns:
        A reference to this Builder instance
      • relatedArtifact

        public ResearchStudy.Builder relatedArtifact​(Collection<RelatedArtifact> relatedArtifact)
        Citations, references and other related documents.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        relatedArtifact - References and dependencies
        Returns:
        A reference to this Builder instance
      • keyword

        public ResearchStudy.Builder keyword​(CodeableConcept... keyword)
        Key terms to aid in searching for or filtering the study.

        Adds new element(s) to the existing list

        Parameters:
        keyword - Used to search for the study
        Returns:
        A reference to this Builder instance
      • keyword

        public ResearchStudy.Builder keyword​(Collection<CodeableConcept> keyword)
        Key terms to aid in searching for or filtering the study.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        keyword - Used to search for the study
        Returns:
        A reference to this Builder instance
      • location

        public ResearchStudy.Builder location​(CodeableConcept... location)
        Indicates a country, state or other region where the study is taking place.

        Adds new element(s) to the existing list

        Parameters:
        location - Geographic region(s) for study
        Returns:
        A reference to this Builder instance
      • location

        public ResearchStudy.Builder location​(Collection<CodeableConcept> location)
        Indicates a country, state or other region where the study is taking place.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        location - Geographic region(s) for study
        Returns:
        A reference to this Builder instance
      • description

        public ResearchStudy.Builder description​(Markdown description)
        A full description of how the study is being conducted.
        Parameters:
        description - What this is study doing
        Returns:
        A reference to this Builder instance
      • enrollment

        public ResearchStudy.Builder enrollment​(Reference... enrollment)
        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".

        Adds new element(s) to the existing list

        Parameters:
        enrollment - Inclusion & exclusion criteria
        Returns:
        A reference to this Builder instance
      • enrollment

        public ResearchStudy.Builder enrollment​(Collection<Reference> enrollment)
        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".

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        enrollment - Inclusion & exclusion criteria
        Returns:
        A reference to this Builder instance
      • period

        public ResearchStudy.Builder period​(Period period)
        Identifies the start date and the expected (or actual, depending on status) end date for the study.
        Parameters:
        period - When the study began and ended
        Returns:
        A reference to this Builder instance
      • sponsor

        public ResearchStudy.Builder sponsor​(Reference sponsor)
        An organization that initiates the investigation and is legally responsible for the study.

        Allowed resource types for this reference:

        Parameters:
        sponsor - Organization that initiates and is legally responsible for the study
        Returns:
        A reference to this Builder instance
      • principalInvestigator

        public ResearchStudy.Builder principalInvestigator​(Reference principalInvestigator)
        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.

        Allowed resource types for this reference:

        Parameters:
        principalInvestigator - Researcher who oversees multiple aspects of the study
        Returns:
        A reference to this Builder instance
      • site

        public ResearchStudy.Builder site​(Reference... site)
        A facility in which study activities are conducted.

        Adds new element(s) to the existing list

        Parameters:
        site - Facility where study activities are conducted
        Returns:
        A reference to this Builder instance
      • site

        public ResearchStudy.Builder site​(Collection<Reference> site)
        A facility in which study activities are conducted.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        site - Facility where study activities are conducted
        Returns:
        A reference to this Builder instance
      • reasonStopped

        public ResearchStudy.Builder reasonStopped​(CodeableConcept reasonStopped)
        A description and/or code explaining the premature termination of the study.
        Parameters:
        reasonStopped - accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
        Returns:
        A reference to this Builder instance
      • note

        public ResearchStudy.Builder note​(Annotation... note)
        Comments made about the study by the performer, subject or other participants.

        Adds new element(s) to the existing list

        Parameters:
        note - Comments made about the study
        Returns:
        A reference to this Builder instance
      • note

        public ResearchStudy.Builder note​(Collection<Annotation> note)
        Comments made about the study by the performer, subject or other participants.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        note - Comments made about the study
        Returns:
        A reference to this Builder instance
      • arm

        public ResearchStudy.Builder arm​(ResearchStudy.Arm... arm)
        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.

        Adds new element(s) to the existing list

        Parameters:
        arm - Defined path through the study for a subject
        Returns:
        A reference to this Builder instance
      • arm

        public ResearchStudy.Builder arm​(Collection<ResearchStudy.Arm> arm)
        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.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        arm - Defined path through the study for a subject
        Returns:
        A reference to this Builder instance
      • objective

        public ResearchStudy.Builder objective​(ResearchStudy.Objective... objective)
        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.

        Adds new element(s) to the existing list

        Parameters:
        objective - A goal for the study
        Returns:
        A reference to this Builder instance
      • objective

        public ResearchStudy.Builder objective​(Collection<ResearchStudy.Objective> objective)
        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.

        Replaces the existing list with a new one containing elements from the Collection

        Parameters:
        objective - A goal for the study
        Returns:
        A reference to this Builder instance