Assembly Templates and Controlled Vocabulary Dependencies

Define the eCTD 4.0 submission structure with additional attributes and simplify your assembly template and CV dependency management.

Regulatory agencies provide lists of headings, controlled vocabularies with names, Context of Use codes, additional attributes and more. The structure of an eCTD 4.0 submission is defined by all of these components. Assembly template created for specific specification version includes the correct structure of headings, with specified Context of Use codes. These codes conform to the controlled vocabularies provided with the same specification. The assembly template gets value in conjunction with corresponding Context of Use codes. When different versions of controlled vocabularies and assembly templates are used, it can lead to unexpected behavior. The Context of Use codes controlled vocabulary is reliant on other CVs that define additional attributes. Controlled vocabularies are used in a special Envelope configuration to provide regional information for a given specification version. In Ennov InSight , all controlled vocabularies of some specification version are grouped as a CV profile. You can easily manage assembly templates and their CV dependencies using CV profiles.