DICOM PS3.3 2020a - Information Object Definitions

C.34.15 Protocol Approval (Current)
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### C.34.15 Protocol Approval

The Protocol Approval Module records approvals of the content of one or more SOP Instances containing protocols by a person or device.

An approval is modeled as a form of Assertion. The nature of the approval is defined by the Assertion Code in the embedded Assertion Macro.

Neither the Protocol Approval Module nor the underlying Assertion Macro address securing the approved instance against tampering (e.g., via a digital hash) or authenticating the identity of the source of the Assertion.

Table C.34.15-1. Protocol Approval Module Attributes

Attribute Name | Tag | Type | Attribute Description
--- | --- | --- | ---
Approval Subject Sequence | (0044,0109) | 1 | Instances that are the subject of the Approval Sequence. All Assertions in the Approval Sequence (0044,0100) apply to all instances in this Sequence. One or more Items shall be included in this Sequence.
>Include Table 10-11 “SOP Instance Reference Macro Attributes” |
Approval Sequence | (0044,0100) | 1 | Recorded approvals of the subject instances. One or more Items shall be included in this Sequence.
>Include Table 10.30-1 “Assertion Macro Attributes” | BCID 800 “Protocol Assertion Codes” for the Assertion Code Sequence. The Approver is recorded in the Asserter Identification Sequence inside the Assertion Macro.
>Institution Code Sequence | (0008,0082) | 1C | Institution or organization for which use of the protocol is approved/disapproved or eligible/ineligible for reimbursement. ### Note The institution identified by the code can represent a hospital network, a hospital, a clinic or a department. An institition can assign codes for it's subsidiary organizations. Required if Assertion Code Sequence (0044,0101) is (128603, DCM, "Approved for use at the institution") or (128623, DCM, "Disapproved for use at the institution") or (128613, DCM, "Eligible for reimbursement") or (128614, DCM, "Eligible for reimbursement on per patient basis") or (128615, DCM, "Ineligible for reimbursement").
>>Include Table 8.8-1 “Code Sequence Macro Attributes” | No Baseline CID defined
>Clinical Trial Protocol ID | (0012,0020) | 1C | Identifier of the clinical trial protocol for which use of the protocol is approved or disapproved. ### Note For experimental use this Attribute is used to identify the experiment. Required if Assertion Code Sequence (0044,0101) is (128604, DCM, "Approved for use in the clinical trial") or (128624, DCM, "Disapproved for use in the clinical trial") or (128611, DCM, "Approved for experimental use") or (128612, DCM, "Disapproved for experimental use").

### Note

The institution for which use of the protocol is approved (recorded in the Approval Sequence (0044,0100) Item) may or may not differ from the institution that is currently responsible for managing the protocol instance (recorded in the Custodial Organization Sequence (0040,A07C) of the Defined Protocol instance). Similarly, the clinical trial for which use of the protocol is approved (recorded in the Approval Sequence (0044,0100) Item) may or may not differ from the clinical trial, if any, for which the protocol instance was originally designed (recorded in the Clinical Trial Context of the Defined Protocol instance).

A number of the Assertion codes in CID 800 “Protocol Assertion Codes” affirm details related to Attributes in a Protocol object. The Protocol Attributes associated with each Assertion code are shown in Table C.34.15-2. A receiving system might display the associated Attribute contents together with the Assertion code to convey the full meaning of the Assertion.

Table C.34.15-2. Associated Attributes for Protocol Assertion Codes

Coding Scheme Designator | Code Value | Code Meaning | Associated Attribute
--- | --- | --- | ---
DCM | 128601 | Appropriate for the indications | Potential Reasons for Procedure Code Sequence (0018,9909)
DCM | 128621 | Inappropriate for the indications | Potential Reasons for Procedure Code Sequence (0018,9909)
DCM | 128602 | Consistent with labeling of the device | Model Specification Sequence (0018,9912)
DCM | 128622 | Inconsistent with labeling of the device | Model Specification Sequence (0018,9912)
DCM | 128606 | Appropriate for the device | Model Specification Sequence (0018,9912)
DCM | 128618 | Inappropriate for the device | Model Specification Sequence (0018,9912)
DCM | 128607 | Inside operational limits of the device | Model Specification Sequence (0018,9912)
DCM | 128619 | Outside operational limits of the device | Model Specification Sequence (0018,9912)
DCM | 128608 | Optimized for the device instance | Model Specification Sequence (0018,9912) Device Serial Number (0018,1000)
DCM | 128620 | Not optimized for the device instance | Model Specification Sequence (0018,9912) Device Serial Number (0018,1000)

### Note

An instance may contain multiple approvals. Receiving systems will determine which approvals apply and what may be useful to display to the system operator.

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DICOM PS3.3 2020a - Information Object Definitions