| ResearchSubject | 0..* | ResearchSubject | A physical entity which is the primary unit of operational and/or administrative interest in a study. |
| ResearchSubject.id | 0..1 | http://hl7.org/fhirpath/System.String | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. |
| ResearchSubject.meta | 0..1 | 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. |
| ResearchSubject.implicitRules | 0..1 | uri | 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. |
| ResearchSubject.language | 0..1 | code | The base language in which the resource is written. |
| ResearchSubject.text | 0..1 | Narrative | 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. |
| ResearchSubject.contained | 0..* | Resource | 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. |
| ResearchSubject.extension | 0..* | 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. |
| ResearchSubject.modifierExtension | 0..* | Extension | 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). |
| ResearchSubject.identifier | 0..* | Identifier | Identifiers assigned to this research subject for a study. |
| ResearchSubject.status | 1..1 | code | The current state of the subject. |
| ResearchSubject.period | 0..1 | Period | The dates the subject began and ended their participation in the study. |
| ResearchSubject.study | 1..1 | Reference | Reference to the study the subject is participating in. |
| ResearchSubject.individual | 1..1 | Reference | The record of the person or animal who is involved in the study. |
| ResearchSubject.assignedArm | 0..1 | string | The name of the arm in the study the subject is expected to follow as part of this study. |
| ResearchSubject.actualArm | 0..1 | string | The name of the arm in the study the subject actually followed as part of this study. |
| ResearchSubject.consent | 0..1 | Reference | A record of the patient's informed agreement to participate in the study. |