eCTD 4.0 Template Files

Ennov InSight includes ICH-compliant eCTD templates associated to Context of Use codes.

Some Context of Use codes include additional attributes defined by controlled vocabularies. The relationship between assembly templates and controlled vocabularies is defined through CV profiles in Publishing Settings Library. To ensure that you have the most current version of each listed template file on your system, refer to the New/Updated in Version column in the table. This column contains information about the template status for each version in the Ennov InSight 7.3 branch:

— No - template was not updated

— Yes - template was updated

— New - template is new with this Ennov InSight version

— Blank - template did not exist for the release

Template New/Updated in Version
7.3
JAP eCTD 4.0 Module 1 v1.5 New

Ennov InSight Publisher 7.3: eCTD 4.0 eCTD 4.0 Template Files

eCTD 4.0 Templates

Template New/Updated in Version
7.3
USA eCTD 4.0 Module 1 v1.5.1 New
ICH eCTD 4.0 Module 2-5 v1.5 New