Computed Radiography ImageCIOD
PatientMModule - Patient
Clinical Trial SubjectUModule - Patient
General StudyMModule - Study
Patient StudyUModule - Study
Clinical Trial StudyUModule - Study
(0012,0050) Clinical Trial Time Point ID2Long String
(0012,0051) Clinical Trial Time Point Description3Short Text
(0012,0052) Longitudinal Temporal Offset from Event3Double
(0012,0053) Longitudinal Temporal Event Type1CCode String
(0012,0054) Clinical Trial Time Point Type Code Sequence3Sequence
(0012,0055) Issuer of Clinical Trial Time Point ID3Long String
(0012,0083) Consent for Clinical Trial Use Sequence3Sequence
(0012,0020) Clinical Trial Protocol ID1CLong String
(0012,0022) Issuer of Clinical Trial Protocol ID3Long String
(0012,0084) Distribution Type1CCode String
(0012,0085) Consent for Distribution Flag1Code String
General SeriesMModule - Series
CR SeriesMModule - Series
Clinical Trial SeriesUModule - Series
General EquipmentMModule - Equipment
General AcquisitionMModule - Acquisition
General ImageMModule - Image
General ReferenceUModule - Image
Image PixelMModule - Image
Contrast/BolusCModule - Image
Display ShutterUModule - Image
DeviceUModule - Image
SpecimenUModule - Image
CR ImageMModule - Image
Overlay PlaneUModule - Image
Modality LUTUModule - Image
VOI LUTUModule - Image
SOP CommonMModule - Image
Common Instance ReferenceUModule - Image
CT ImageCIOD
MR ImageCIOD
Nuclear Medicine ImageCIOD
Ultrasound ImageCIOD
Ultrasound Multi-frame ImageCIOD
Secondary Capture ImageCIOD
Multi-frame Single Bit Secondary Capture ImageCIOD
Multi-frame Grayscale Byte Secondary Capture ImageCIOD
Multi-frame Grayscale Word Secondary Capture ImageCIOD
Multi-frame True Color Secondary Capture ImageCIOD
X-Ray Angiographic ImageCIOD
X-Ray Radiofluoroscopic ImageCIOD
RT ImageCIOD
RT DoseCIOD
RT Structure SetCIOD
RT PlanCIOD
Positron Emission Tomography ImageCIOD
Digital X-Ray ImageCIOD
Digital Mammography X-Ray ImageCIOD
Digital Intra-Oral X-Ray ImageCIOD
RT Beams Treatment RecordCIOD
RT Brachy Treatment RecordCIOD
RT Treatment Summary RecordCIOD
VL Endoscopic ImageCIOD
VL Microscopic ImageCIOD
VL Slide-Coordinates Microscopic ImageCIOD
VL Photographic ImageCIOD
Video Endoscopic ImageCIOD
Video Microscopic ImageCIOD
Video Photographic ImageCIOD
VL Whole Slide Microscopy ImageCIOD
Real-Time Video Endoscopic ImageCIOD
Real-Time Video Photographic ImageCIOD
Dermoscopic Photography ImageCIOD
Grayscale Softcopy Presentation StateCIOD
Color Softcopy Presentation StateCIOD
Pseudo-Color Softcopy Presentation StateCIOD
Blending Softcopy Presentation StateCIOD
Basic Structured DisplayCIOD
XA/XRF Grayscale Softcopy Presentation StateCIOD
Advanced Blending Presentation StateCIOD
Variable Modality LUT Softcopy Presentation StateCIOD
Basic Voice Audio WaveformCIOD
12-Lead ECGCIOD
General ECGCIOD
Ambulatory ECGCIOD
Hemodynamic WaveformCIOD
Basic Cardiac Electrophysiology WaveformCIOD
Arterial Pulse WaveformCIOD
Respiratory WaveformCIOD
General Audio WaveformCIOD
Real-Time Audio WaveformCIOD
Routine Scalp ElectroencephalogramCIOD
ElectromyogramCIOD
ElectrooculogramCIOD
Sleep ElectroencephalogramCIOD
Multi-channel Respiratory WaveformCIOD
Body Position WaveformCIOD
General 32-bit ECGCIOD
Basic Text SRCIOD
Enhanced SRCIOD
Comprehensive SRCIOD
Key Object Selection DocumentCIOD
Mammography CAD SRCIOD
Chest CAD SRCIOD
Procedure LogCIOD
X-Ray Radiation Dose SRCIOD
Spectacle Prescription ReportCIOD
Colon CAD SRCIOD
Macular Grid Thickness and Volume ReportCIOD
Implantation Plan SR DocumentCIOD
Comprehensive 3D SRCIOD
Radiopharmaceutical Radiation Dose SRCIOD
Extensible SRCIOD
Acquisition Context SRCIOD
Simplified Adult Echo SRCIOD
Patient Radiation Dose SRCIOD
Planned Imaging Agent Administration SRCIOD
Performed Imaging Agent Administration SRCIOD
Rendition Selection DocumentCIOD
Enhanced X-Ray Radiation Dose SRCIOD
Enhanced MR ImageCIOD
MR SpectroscopyCIOD
Enhanced MR Color ImageCIOD
Raw DataCIOD
Enhanced CT ImageCIOD
Spatial RegistrationCIOD
Deformable Spatial RegistrationCIOD
Spatial FiducialsCIOD
Ophthalmic Photography 8 Bit ImageCIOD
Ophthalmic Photography 16 Bit ImageCIOD
Stereometric RelationshipCIOD
Hanging ProtocolCIOD
Encapsulated PDFCIOD
Encapsulated CDACIOD
Real World Value MappingCIOD
Enhanced XA ImageCIOD
Enhanced XRF ImageCIOD
RT Ion PlanCIOD
RT Ion Beams Treatment RecordCIOD
SegmentationCIOD
Ophthalmic Tomography ImageCIOD
X-Ray 3D Angiographic ImageCIOD
X-Ray 3D Craniofacial ImageCIOD
Breast Tomosynthesis ImageCIOD
Enhanced PET ImageCIOD
Surface SegmentationCIOD
Color PaletteCIOD
Enhanced US VolumeCIOD
Lensometry MeasurementsCIOD
Autorefraction MeasurementsCIOD
Keratometry MeasurementsCIOD
Subjective Refraction MeasurementsCIOD
Visual Acuity MeasurementsCIOD
Ophthalmic Axial MeasurementsCIOD
Intraocular Lens CalculationsCIOD
Generic Implant TemplateCIOD
Implant Assembly TemplateCIOD
Implant Template GroupCIOD
RT Beams Delivery InstructionCIOD
Ophthalmic Visual Field Static Perimetry MeasurementsCIOD
Intravascular Optical Coherence Tomography ImageCIOD
Ophthalmic Thickness MapCIOD
Surface Scan MeshCIOD
Surface Scan Point CloudCIOD
Legacy Converted Enhanced CT ImageCIOD
Legacy Converted Enhanced MR ImageCIOD
Legacy Converted Enhanced PET ImageCIOD
Corneal Topography MapCIOD
Breast Projection X-Ray ImageCIOD
Parametric MapCIOD
Wide Field Ophthalmic Photography Stereographic Projection ImageCIOD
Wide Field Ophthalmic Photography 3D Coordinates ImageCIOD
Tractography ResultsCIOD
RT Brachy Application Setup Delivery InstructionCIOD
Planar MPR Volumetric Presentation StateCIOD
Volume Rendering Volumetric Presentation StateCIOD
Content Assessment ResultsCIOD
CT Performed Procedure ProtocolCIOD
CT Defined Procedure ProtocolCIOD
Protocol ApprovalCIOD
XA Performed Procedure ProtocolCIOD
XA Defined Procedure ProtocolCIOD
Ophthalmic Optical Coherence Tomography En Face ImageCIOD
Ophthalmic Optical Coherence Tomography B-scan Volume AnalysisCIOD
Encapsulated STLCIOD
Encapsulated OBJCIOD
Encapsulated MTLCIOD
RT Physician IntentCIOD
RT Segment AnnotationCIOD
RT Radiation SetCIOD
C-Arm Photon-Electron RadiationCIOD
Tomotherapeutic RadiationCIOD
Robotic-Arm RadiationCIOD
RT Radiation Record SetCIOD
RT Radiation Salvage RecordCIOD
C-Arm Photon-Electron Radiation RecordCIOD
Tomotherapeutic Radiation RecordCIOD
Robotic-Arm Radiation RecordCIOD
RT Radiation Set Delivery InstructionCIOD
RT Treatment PreparationCIOD
Enhanced RT ImageCIOD
Enhanced Continuous RT ImageCIOD
RT Patient Position Acquisition InstructionCIOD
Microscopy Bulk Simple AnnotationsCIOD
InventoryCIOD
Photoacoustic ImageCIOD
Confocal Microscopy ImageCIOD
Confocal Microscopy Tiled Pyramidal ImageCIOD
Basic DirectoryCIOD

Built with by Innolitics, a team of medical imaging software developers.

Data synced with official DICOM standard on 18 April 2024. The DICOM Standard is under continuous maintenance, and the current official version is available at http://www.dicomstandard.org/current/. DICOM Parts 3, 4, and 6, © NEMA. Please note that the most recent PDF version of the standard is the official reference, and should checked when making technical decisions.

Clinical Trial Protocol ID Attribute

Tag(0012,0020)
TypeConditionally Required (1C)
KeywordClinicalTrialProtocolID
Value Multiplicity1
Value RepresentationLong String (LO)
Example Values
  • UCSF_PILOT
  • 6668
  • 6688

The identifier of the protocol for which consent to distribute has been granted.

Required if Distribution Type (0012,0084) is NAMED_PROTOCOL and the protocol is not that which is specified in Clinical Trial Protocol ID (0012,0020) in the Clinical Trial Subject Module.

Clinical Trial Subject Module

C.7.1.3 Clinical Trial Subject Module

Table C.7-2b specifies the Attributes of the Clinical Trial Subject Module, which identify a Patient as a clinical trial or research Subject.

Table C.7-2b. Clinical Trial Subject Module Attributes

Attribute Name

Tag

Type

Attribute Description

Clinical Trial Sponsor Name

(0012,0010)

1

The name of the clinical trial or research sponsor. See Section C.7.1.3.1.1.

Clinical Trial Protocol ID

(0012,0020)

1

Identifier for the protocol. See Section C.7.1.3.1.2.

Issuer of Clinical Trial Protocol ID

(0012,0022)

3

Identifier of the Assigning Authority that issued the Clinical Trial Protocol ID (0012,0020).

Other Clinical Trial Protocol IDs Sequence

(0012,0023)

3

Identification numbers or codes used to identify the protocol.

One or more Items are permitted in this Sequence.

>Clinical Trial Protocol ID

(0012,0020)

1

Identifier for the protocol. See Section C.7.1.3.1.2.

>Issuer of Clinical Trial Protocol ID

(0012,0022)

1

Identifier of the Assigning Authority that issued the Clinical Trial Protocol ID (0012,0020).

Clinical Trial Protocol Name

(0012,0021)

2

The name of the clinical trial or research 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 or research data. See Section C.7.1.3.1.4.

Issuer of Clinical Trial Site ID

(0012,0032)

3

Identifier of the Assigning Authority that issued the Clinical Trial Site ID (0012,0030).

Clinical Trial Site Name

(0012,0031)

2

Name of the site responsible for submitting clinical trial or research data. See Section C.7.1.3.1.5

Clinical Trial Subject ID

(0012,0040)

1C

The assigned identifier for the clinical trial or research subject. See Section C.7.1.3.1.6. Shall be present if Clinical Trial Subject Reading ID (0012,0042) is absent. May be present otherwise.

Issuer of Clinical Trial Subject ID

(0012,0041)

3

Identifier of the Assigning Authority that issued the Clinical Trial Subject ID (0012,0040).

Clinical Trial Subject Reading ID

(0012,0042)

1C

Identifies the subject for blinded evaluations. Shall be present if Clinical Trial Subject ID (0012,0040) is absent. May be present otherwise. See Section C.7.1.3.1.7.

Issuer of Clinical Trial Subject Reading ID

(0012,0043)

3

Identifier of the Assigning Authority that issued the Clinical Trial Subject Reading ID (0012,0042).

Clinical Trial Protocol Ethics Committee Name

(0012,0081)

1C

Name of the Ethics Committee or Institutional Review Board (IRB) or Institutional Animal Care and Use Committees (IACUC) responsible for approval of the Clinical Trial or research. 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).


C.7.1.3.1 Clinical Trial Subject Module Attribute Descriptions

Identification of subjects in clinical trials or research generally requires a combination of the following four Attributes:

  1. Clinical Trial Sponsor Name (0012,0010),

  2. Clinical Trial Protocol ID (0012,0020),

  3. Clinical Trial Subject ID (0012,0040) (or Clinical Trial Subject Reading ID (0012,0042) for blinded evaluations), and

  4. Clinical Trial Site ID (0012,0030).

For trials in which subject identifiers are unique within the scope of the Clinical Trial Protocol (e.g., if subject identifiers are centrally assigned or contain the site identifier) the Clinical Trial Site ID (0012,0030) is not required to identify subjects.

C.7.1.3.1.1 Clinical Trial Sponsor Name

The Clinical Trial Sponsor Name (0012,0010) identifies the entity responsible for conducting the clinical trial or research and for defining the Clinical Trial Protocol ID (0012,0020).

C.7.1.3.1.2 Clinical Trial Protocol ID

The Clinical Trial Protocol ID (0012,0020) is the number or character sequence used by the Clinical Trial Sponsor to uniquely identify the investigational protocol in which the subject has been enrolled.

Note

If there is a need to record more than one identifier for the protocol, one may be conveyed Clinical Trial Protocol ID (0012,0020) in the top level dataset and the others included in Other Clinical Trial Protocol IDs Sequence (0012,0023), and the source of each distinguished by their Issuer of Clinical Trial Protocol ID (0012,0022).

Here is an example of identifying a completed trial whose data has been shared and assigned a digital object identifier:

  • Clinical Trial Protocol ID (0012,0020) = "TCGA-GBM"

  • Issuer of Clinical Trial Protocol ID (0012,0022) = "NCI"

  • Other Clinical Trial Protocol IDs Sequence (0012,0023)

    • >Clinical Trial Protocol ID (0012,0020) = "doi:10.7937/K9/TCIA.2016.RNYFUYE9"

    • >Issuer of Clinical Trial Protocol ID (0012,0022) = "DOI"

Here is an example of identifying a clinical trial that is potentially ongoing and not yet published or shared, and has multiple (primary and secondary) identifiers from the same issuer (which are enumerated but not otherwise distinguished from each other):

  • Clinical Trial Protocol ID (0012,0020) = "D6940C00002"

  • Issuer of Clinical Trial Protocol ID (0012,0022) = "NCI"

  • Other Clinical Trial Protocol IDs Sequence (0012,0023)

    • >Clinical Trial Protocol ID (0012,0020) = "NCI-2018-00805"

    • >Issuer of Clinical Trial Protocol ID (0012,0022) = "NCI"

    • >Clinical Trial Protocol ID (0012,0020) = "135803"

    • >Issuer of Clinical Trial Protocol ID (0012,0022) = "NCI"

    • >Clinical Trial Protocol ID (0012,0020) = "2017-002451-28"

    • >Issuer of Clinical Trial Protocol ID (0012,0022) = "NCI"

    • >Clinical Trial Protocol ID (0012,0020) = "NCT03423628"

    • >Issuer of Clinical Trial Protocol ID (0012,0022) = "ClinicalTrials.gov"

C.7.1.3.1.3 Clinical Trial Protocol Name

The Clinical Trial Protocol Name (0012,0021) contains the title of the investigational protocol in which the subject has been enrolled.

Note

It is recommended that the phase of the clinical trial or research be noted in the Clinical Trial Protocol Name, if applicable.

C.7.1.3.1.4 Clinical Trial Site ID

The Clinical Trial Site ID (0012,0030) is the identification number or character string (issued by the entity identified by the Clinical Trial Sponsor Name (0012,0010)) used to identify the site responsible for submitting clinical trial or research data.

C.7.1.3.1.5 Clinical Trial Site Name

The Clinical Trial Site Name (0012,0031) is a character string used to identify the site responsible for submitting clinical trial or research data.

C.7.1.3.1.6 Clinical Trial Subject ID

The Clinical Trial Subject ID (0012,0040) identifies the subject within the investigational protocol specified by Clinical Trial Protocol ID (0012,0020).

Note

The Clinical Trial Subject ID (0012,0040) may, but is not required to be, the same as Patient ID (0010,0020).

C.7.1.3.1.7 Clinical Trial Subject Reading ID

The Clinical Trial Subject Reading ID (0012,0042) identifies the subject in the context of blinded evaluations.