C.7.1.3.1 Clinical Trial Subject Attribute Descriptions

Identification of subjects in clinical trials 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 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.

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 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 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 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).

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.