7.6 EXTENSION OF THE DICOM MODEL OF THE REAL WORLD FOR CLINICAL TRIALS

The DICOM Model of the Real World is extended for Clinical Trials with the addition of several objects whose relationships to each other and existing DICOM Real World objects are shown in Figure 7.6-1.

Attributes of the Clinical Trial Sponsor, Clinical Trial Protocol, Clinical Trial Subject, and Clinical Trial Site objects are represented in the Clinical Trial Subject Module within the Patient IOD. Attributes of the Clinical Trial Time Point object are represented in the Clinical Trial Study Module within the Study IOD. The Clinical Trial Coordinating Center attribute is represented in the Clinical Trial Series Module within Image IODs.

[pic]Figure 7.6-1 - DICOM MODEL OF THE REAL WORLD - CLINICAL TRIALS

7.6.1 Clinical Trial Information Entities

For the purpose of Clinical Trial 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

A Clinical Trial Sponsor identifies the agency, group, or institution responsible for conducting the clinical trial 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.

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 institution at which the Subject is treated or evaluated and which is responsible for submitting clinical trial 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.

7.6.1.5 Clinical Trial Time Point

The Clinical Trial Time Point identifies an imaging Study within the context of an investigational protocol. A Time Point defines a set of studies that are grouped together as a clinical time point or submission in a clinical trial.

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. 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.