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.