Class TAdverseEventSupportingInfo

Unit

Declaration

type TAdverseEventSupportingInfo = class(TBackboneElement)

Description

An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.

Hierarchy

Overview

Methods

Public constructor Create; override;

Properties

Public property itemReference : TReference read GetitemReference write SetitemReference;
Public property itemCodeableConcept : TCodeableConcept read GetitemCodeableConcept write SetitemCodeableConcept;

Description

Methods

Public constructor Create; override;
 

Properties

Public property itemReference : TReference read GetitemReference write SetitemReference;

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a pencillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action. (choose any one of item*, but only one)

Public property itemCodeableConcept : TCodeableConcept read GetitemCodeableConcept write SetitemCodeableConcept;

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a pencillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action. (choose any one of item*, but only one)


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