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Class: ResearchSubject

A research subject is the entity of interest in a research study, typically a human being or an animal, but can also be a device, group of humans or animals, or a tissue sample. Human research subjects are usually not traceable to a particular person to protect the subject’s privacy.

URI: crdch:ResearchSubject

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Parents

  • is_a: Entity - Any resource that has its own identifier

Referenced by Class

Attributes

Own

  • id 1..1
    • Description: The 'logical' identifier of the entity within the system of record. The simple value of this attribute stands for an identifier of this data object within the system, it can be used as a reference from other objects within the same system (i.e. primary and foreign keys), and it should be unique per type of object. The same data object copied to a different system will likely have a different "id" in the new system since "id" values are system specific and do not represent persistent business identifiers. Business identifiers are assigned outside the information system and are captured in the "identifier" field. The "id" field is more likely to be a serially or randomly generated value that is assigned to the data object as it is created in a system.
    • Range: CrdchString
  • identifier 0..*
    • Description: A 'business' identifier or accession number for the entity, typically as provided by an external system or authority, that are globally unique and persist across implementing systems. Also, since these identifiers are created outside the information system through a specific business process, the Identifier type has additional attributes to capture this additional metadata so the actual identifier values are qualified by the context that created those values. This additional context allows "identifier" instances to be transmitted as business data across systems while still being able to trace them back to the system of origin.
    • Range: Identifier
  • description 0..1
    • Description: A free text field to capture additional info/explanation about the research subject.
    • Range: CrdchString
  • member_of_research_project 0..1
    • Description: A reference to the Study(s) of which this ResearchSubject is a member
    • Range: ResearchProject
  • age_at_enrollment 0..1
    • Description: The age in days when the Subject enrolled on the ResearchProject
    • Range: Quantity
  • primary_diagnosis_condition 0..1
    • Description: The text term used to describe the type of malignant disease, as categorized by the World Health Organization's (WHO) International Classification of Diseases for Oncology (ICD-O). This attribute represents the disease that qualified the subject for inclusion on the ResearchProject
    • Range: CodeableConcept
    • Examples: Acinar Cell Neoplasms, Adenomas and Adenocarcinomas, Adnexal and Skin Appendage Neoplasms
  • primary_diagnosis_site 0..1
    • Description: The text term used to describe the primary site of disease, as categorized by the World Health Organization's (WHO) International Classification of Diseases for Oncology (ICD-O). This categorization groups cases into general categories. This attribute represents the primary site of disease that qualified the subject for inclusion on the ResearchProject.
    • Range: BodySite
    • Examples: Accessory sinuses, Adrenal gland, Anus and anal canal
  • primary_diagnosis 0..*
    • Description: The diagnosis instance that qualified a subject for inclusion on a ResearchProject
    • Range: Diagnosis
  • comorbid_diagnosis 0..*
    • Description: One or more diagnosis instance that are comorbid with the primary_diagnosis that qualified a subject for inclusion on a ResearchProject
    • Range: Diagnosis
  • index_timepoint 0..1
    • Description: The text term used to describe the reference or anchor date used for date obfuscation, where a single date is obscured by creating one or more date ranges in relation to this date.
    • Range: CodeableConcept
    • Examples: Diagnosis, First Patient Visit, First Treatment
  • originating_site 0..1
    • Description: The Organization at which a subject was enrolled on a ResearchProject.
    • Range: Organization
  • associated_subject 1..1
    • Description: A reference to the Subject that is this ResearchSubject
    • Range: Subject