Clinical Trial Protocol ID Attribute
| Tag | (0012,0020) |
|---|---|
| Type | Conditionally Required (1C) |
| Keyword | ClinicalTrialProtocolID |
| Value Multiplicity | 1 |
| Value Representation | Long String (LO) |
| Example Values |
|
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:
-
Clinical Trial Sponsor Name (0012,0010),
-
Clinical Trial Protocol ID (0012,0020),
-
Clinical Trial Subject ID (0012,0040) (or Clinical Trial Subject Reading ID (0012,0042) for blinded evaluations), and
-
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.