DICOM PS3.3 2019a - Information Object Definitions

C.34.4 Clinical Trial Context Module

Table C.34.4-1 contains Attributes that identify a clinical trial context independent of any specific Clinical Trial Subjects.

Table C.34.4-1. Clinical Trial Context Module Attributes

Attribute Name

Tag

Type

Attribute Description

Clinical Trial Sponsor Name

(0012,0010)

1

The name of the clinical trial sponsor.

See Section C.7.1.3.1.1.

Clinical Trial Protocol ID

(0012,0020)

1

Identifier for the noted protocol .

See Section C.7.1.3.1.2.

Clinical Trial Protocol Name

(0012,0021)

2

The name of the clinical trial protocol .See Section C.7.1.3.1.3.

Clinical Trial Site ID

(0012,0030)

2

The identifier of the site responsible for submitting clinical trial data.

See Section C.7.1.3.1.4.

Clinical Trial Site Name

(0012,0031)

2

Name of the site responsible for submitting clinical trial data.

See Section C.7.1.3.1.5.

Clinical Trial Protocol Ethics Committee Name

(0012,0081)

1C

Name of the Ethics Committee or Institutional Review Board (IRB) responsible for approval of the Clinical Trial.

Required if Clinical Trial Protocol Ethics Committee Approval Number (0012,0082) is present.

Clinical Trial Protocol Ethics Committee Approval Number

(0012,0082)

3

Approval number issued by committee described in Clinical Trial Protocol Ethics Committee Name (0012,0081).

Ethics Committee Approval Effectiveness Start Date

(0012,0086)

3

The date the approval identified in Clinical Trial Protocol Ethics Committee Approval Number (0012,0082) becomes effective.

Ethics Committee Approval Effectiveness End Date

(0012,0087)

3

The date the approval identified in Clinical Trial Protocol Ethics Committee Approval Number (0012,0082) ceases to be effective.

Clinical Trial Coordinating Center Name

(0012,0060)

2

The name of the institution that is responsible for coordinating the protocols for the clinical trial. See Section C.7.3.2.1.1.


DICOM PS3.3 2019a - Information Object Definitions