eCTD 4.0 Submission Maintenance
Use eCTD 4.0 Submission Maintenance to specify values for eCTD 4.0 Modules. Use the eCTD 4.0 Submission Maintenance pages to define: — CV Profile values
— Sender-defined Keyword values
When you click a type of value under eCTD 4.0 Submission Maintenance, a page shows a table of all defined values for that type. You can sort these values by column. The default view is sorted in ascending, alphanumeric order.
On the eCTD 4.0 Submission Maintenance values pages, you can set the status of a value to active or inactive.
eCTD 4.0 Submission Maintenance: eCTD 4.0 Submission Values
The following submission values can be created and maintained under eCTD 4.0 Submission Maintenance:
| Value | Description |
| CV Profile | The values that eCTD 4.0 defines to describe controlled vocabulary profile. |
Ennov InSight Administration 7.3 eCTD 4.0 Submission Maintenance
| Value | Description |
| Sender-defined Keyword | The values that eCTD 4.0 users define to get better quality of the data entered. |
CV Profile Attributes
To define an eCTD 4.0 controlled vocabulary profile, enter values for the following attributes:
| Attribute | Description |
| CV Profile Name | Name of the controlled vocabulary profile. |
| Regions | Regions provided by controlled vocabulary service. |
| Version | Versions for the selected region. |
| Category | Category for selected version. |
| Specification Name | Name of the specification that defines the requirements by the agencies. |
| Specification OID | The object identifier of a specification is a sequence of numbers that uniquely identify the specification in the system. |
| Last User Updated | Indicates the name of the user who last created/updated the eCTD 4.0 controlled vocabulary profile. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Active | Indicates if the entity is active or inactive. |
To define an eCTD 4.0 controlled vocabulary profile details, associate the CVs with the following attributes:
Table 1: CV Details Attributes
| Attribute | Description |
| Name | Name of the controlled vocabulary provided by CV service. |
| Version | Version of the controlled vocabulary provided by CV service. |
| OID | Object identifier provided by CV service. |
| Can be associated? | Yes indicates that CV can be selected for association/disassociation. |
| Can be disassociated? | No indicates that CV cannot be associated/disassociated due to existing dependencies. |
Sender-defined Keyword Attributes
To define an sender-defined keyword attributes, enter values for the following attributes:
Ennov InSight Administration 7.3 eCTD 4.0 Submission Maintenance
| Attribute | Description |
| Code | Code of the keyword defined and referenced in eCTD 4.0 published output. |
| Display Name | Name of the sender-defined keyword mapped to the code in eCTD 4.0 published output. |
| Last User Updated | Indicates the name of the user who last created/updated the PDF properties. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Active | Indicates if the entity is active or inactive. |