CV Profiles in Publishing Settings

The CV Profiles (controlled vocabulary profiles) settings determine the set of CVs that is used for publishing your eCTD submission.

These files are generally associated with a specific assembly template, but submissions based on earlier versions of the specification may be updated to newer specifications by selecting the latest CV profile in the Publishing Settings of the active working assembly. CV Profiles are created in Data Administration by accumulating CVs under one profile.

For eCTD 4.0, you typically select a regional CV Profile, and the standard ICH CV profile.

For better experience, one regional CV profile should be assigned to one assembly.