C.34.15 Protocol Approval Module

C.34.15 Protocol Approval Module (Current)
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Table C.34.15-1 specifies the Attributes of the Protocol Approval Module, which record approvals by a person or device of the content of one or more SOP Instances containing protocols.

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”			Assertion Code Sequence (0044,0101) BCID 800 “Protocol Assertion”. 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 institution 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” 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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