eCTD 4.0 CV Profiles

Use the eCTD 4.0 CV Profiles to enable interactions with controlled vocabularies for quick and easy eCTD 4.0 specification updates in future.

Controlled vocabularies (CV) are an essential component of the eCTD v4.0. They provide communication between systems sending and receiving XML messages.

CV Profiles allow you to map a name of controlled vocabulary with the Data Administration values.

Multiple CV entries can be associated to the one CV profile value.

The following table shows the Data Administration value and the СV value it is linked to.

Associate CV Details with Data Administration Entities

You can map a controlled vocabulary to a CV Profile with the Data Administration values using the CV Profile

Name tab available on the Data Administration values attributes page. You can associate multiple CV entries to one CV profile.

Note: There are dependencies between CVs:

— If you associate a CV that includes dependencies, dependent CVs are associated too.

— If you try to associate CV that has No in Can be associated? column that action will fail. — Inactive CVs are not displayed in the eCTD 4.0 CV Profile Values widget.

— The previously assigned but deleted CVs are still displayed in the CV Details tab

— The previously assigned but deleted CVs are not displayed in the eCTD 4.0 CV Profile Values widget after disassociating from the CV Profile.

— The Region, Version, Category values are not removed from the columns in the eCTD 4.0 CV Profile Values page after deleting the whole CV region, or version or category in CV Service.

To associate CV profile name:

1. On the homepage, click Go To > Data Administration > eCTD 4.0 Submission Maintenance.
2. Click CV Profile Values.
3. Click the CV profile to which you want to associate the CV profile name.

   You can create a CV profile if there are none by clicking the Create icon.

4. Select the Region, Version, and Category.

Ennov InSight Administration 7.3 eCTD 4.0 CV Profiles

Note: When you associate the CV Details, the controlled vocabularies are filtered according to these fields in the Search Results box.

5.

On the selected

CV

Profile

Values

page, click the

CV Details

tab.

6.

Click

Associate CV

.

7. Select the CV in the Search Results box and click Associate CV.

You can select one or multiple CVs with Yes value in the Can be associated? column only. The selected CVs are associated with their dependencies.

Disassociate CV Details with Data Administration Entities

You can disassociate CV Details from the Data Administration values using the disassociate icon available on the CV Details tab.

To disassociate CV Details Names: 1. On the homepage, click Go To > Data Administration > eCTD 4.0 Submission Maintenance.

1. Click CV Profile Values
2. On the selected CV Profile Values page, click the CV Details tab.
3. Select the CV, click Dissassociate the CV

   .

   Note: Due to dependencies between CVs, you can only disassociate CVs that have Yes in Can be disassociated?

   column. You cannot disassociate CV that has No in Can be disassociated? column.

4. Click OK on the confirmation message.

CV Details Attributes

The following are the CV Details attributes and their description:

Ennov InSight Administration 7.3 eCTD 4.0 CV Profiles