Материал: part03

Figure 7.6-1. DICOM Model of the Real World - Clinical Trials and Research​

7.6.1 Clinical Trial and Research Information Entities​

For the purpose of Clinical Trial and Research Information, an extension of the DICOM Model of the Real World is made, as depicted​

in Figure 7.6-1.​

7.6.1.1 Clinical Trial Sponsor​

AClinicalTrialSponsoridentifiestheagency,group,orinstitutionresponsibleforconductingand/orfundingtheclinicaltrialorresearch,​ and for assigning a Protocol Identifier.​

7.6.1.2 Clinical Trial Protocol​

A Clinical Trial Protocol identifies the investigational Protocol in which the Subject has been enrolled. The Protocol has a Protocol​ Identifier and Protocol Name, as well as information related to Ethics Committee, Institutional Review Board (IRB) or Institutional​ Animal Care and Use Committees (IACUC) approval.​

7.6.1.3 Clinical Trial Subject​

A Clinical Trial Subject identifies the Patient who is enrolled as a Subject in the investigational Protocol.​

7.6.1.4 Clinical Trial Site​

A Clinical Trial Site identifies the location or institutionat which the Subject is treated or evaluated and that is responsible for submitting​ clinical trial or research data. Images and/or clinical trial data may be collected for a given Subject at alternate institutions, e.g., follow-​ up scans at a satellite imaging center, but the Clinical Trial Site represents the primary location for Patient management and data​ submission in the context of a clinical trial or research. In pre-clinical research with small animals, it is typically the single laboratory​ or shared resource facility.​

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7.6.1.5 Clinical Trial Time Point​

The Clinical Trial Time Point identifies an imaging Study within the context of a series of longitudinal data acquisitions in an investig-​ ational protocol. A Time Point defines a set of Studies that are grouped together as a clinical time point or submission in a clinical​ trial or for other research.​

7.6.1.6 Clinical Trial Coordinating Center​

The Clinical Trial Coordinating Center identifies the institution responsible for coordinating the collection, management, processing,​ and/or analysis of images and associated data for Subjects enrolled in a clinical trial or research. Within a given Clinical Trial Protocol,​ there may be multiple Clinical Trial Coordinating Centers, each handling different aspects of the clinical data submitted by the Clinical​ Trial Sites. In pre-clinical research with small animals, it may be a facility where post processing is performed, separate from the​ laboratory where the data is acquired.​

7.7 Extension of the DICOM Model of the Real World for Hanging Protocols​

See Section 7.13.​

Note​

The specifications of this section have been consolidated into the Real World Model for Non-Patient-Related Information.​

7.8 Extension of the DICOM Model of the Real World for Color Palettes​

See Section 7.13.​

Note​

The specifications of this section have been consolidated into the Real World Model for Non-Patient-Related Information.​

7.9 Extension of the DICOM Model of the Real World for Specimens​

The DICOM Model of the Real World is extended for Specimens with the addition of several objects whose relationships to each​ other and existing DICOM Real World objects are shown in Figure 7.9-1.​

Attributes of the Specimen, Container, Component and Preparation Step objects are represented in the Specimen Module within the​ Image IODs.​

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Patient

Equipment

Modality Study

Figure 7.9-1. DICOM Model of the Real World - Specimens​

7.9.1 Specimen​

A physical object (or a collection of objects) is a specimen when the laboratory considers it a single discrete, uniquely identified unit​ that is the subject of one or more steps in the laboratory (diagnostic) workflow.​

7.9.2 Container​

Specimen containers (or just "containers") play an important role in laboratory (diagnostic) processes. In most, but not all, process​ steps, specimens are held in containers, and a container often carries its specimen's ID. Sometimes the container becomes intimately​ involved with the specimen (e.g., a paraffin block), and in some situations (such as examining tissue under the microscope) the con-​ tainer (the slide and coverslip) become part of the optical path.​

7.9.3 Container Component​

Containers are often made up of components. For example, a "slide" is container that is made up of the glass slide, the coverslip and​ the "glue" the binds them together.​

7.9.4 Preparation Step​

Before a slide is imaged, the preparation of the specimen (including sampling, processing and staining) will take place. Specimen​ preparation is described as a sequence of time-stamped process steps. Multiple steps are possible, and may include sampling from​ ancestor specimens.​

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7.10 Extension of DICOM Model of the Real World for Implant Templates​

See Section 7.13.​

Note​

The specifications of this section have been consolidated into the Real World Model for Non-Patient-Related Information.​

7.11 Extension of the DICOM Model of the Real World for the Unified Procedure​ Step (UPS)​

The DICOM Model of the Real World is extended with the addition of a Unified Procedure Step object whose relationship to existing​ DICOM Real World objects is shown in Figure 7.11-1.​

Patient

1 has

0-n

Service Request

1 has

1-n

Requested Procedure

0-n

Figure 7.11-1. DICOM Model of the Real World - Unified Procedure Step​

7.11.1 Unified Procedure Step​

A Unified Procedure Step (UPS) represents an arbitrary unit of service. Unified Procedure Steps are generally scheduled in response​ to a Requested Procedure, although a UPS may be triggered by other events, such as a scheduled calibration, completion of prior​ work in a pipeline, etc.​

The Unified Procedure Step (UPS) unifies the details of the procedure step that has been requested, the progress details during​ performance, and the details of the procedure step actually performed. The details can describe the specific service activity, the​ subject and/or data acted on, the originator and context of the request, the human/equipment/application resources involved, the​ priority, date, time and location of the activity, and references to resulting output data.​

Normallythedetailsabouttheactivityasperformedcorrespondtothedetailsoftheactivityasrequested,howeverreal-worldconditions​ may dictate that what is actually performed does not correspond exactly with what was requested or scheduled.​

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7.11.2 Worklist​

A Worklist is an arbitrary collection of Unified Procedure Steps that share a common worklist label.​

7.12 Extension of The DICOM Model of The Real World For Display System​

The DICOM Model of the Real World is extended for Display System with the addition of an entity that is separate from the rest of​ the DICOM Real World objects, as shown in Figure 7.12-1. A Display System is not associated with any specific objects in the existing​ DICOM Information model, because it is not associated with a specific Patient. One Display System object is included in a Display​ System IOD.​

Display

System

Figure 7.12-1. DICOM Model of the Real World - Display System​

A Display Subsystem represents the target of a Display QA task such as calibration. For example, a PACS reading station with one​ color controller driving one display, and 4 grayscale displays each driven by two controllers is modeled as 5 Display Subsystems,​ each of which can be the target of a Display QA task. A tablet represents one Display System with a Display Device but no externally​ exposed controller. Although Display Subsystem may include components beyond the Display Device, this Model focuses on the​ Display Device only.​

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