Sender-defined Keywords
Keywords defined by the submitter using the keyword definitions in the eCTD v4.0 message.
Sender-defined keywords are sent for each application but to enable the use of grouped submissions, manage the keyword definitions across applications. The information on the Sender-defined Keywords is read-only. The Senderdefined Keywords tab appears under Application Attributes if the Sequence Standard Type is set up for eCTD 4.0 and the assembly is created.
From an application, you can associate the Sender-defined Keywords to the specific assembly folders. See:
Publishing eCTD 4.0 > Folder Elements > Associate Sender-defined Keywords to an Assembly Folder.
You should have at least Read privileges for Electronic Lifecycle Publishing (ELP) and Submission Planning and Tracking (SPT) to view the Sender-defined Keywords tab.
The Sender-defined Keywords tab includes the following columns:
| Column Name |
Column Type |
Description | |
|
Application Name |
Readonly | The name of application. | |
| Column Name |
Column Type |
Description | |
|
Application Codesystem ID |
Readonly | The unique automatically generated set of symbols that defines the сode system of the sender-defined keywords. | |
| Code | Hyperlink | Sender-defined keyword code defined and referenced in eCTD 4.0 published output. Editable on Create screen and read-only on Edit screen. Unique per Application. | |
| Display Name | Hyperlink | Sender-defined keyword name to be mapped to the Code value in eCTD 4.0 published output. | |