When working with GCC regulatory submissions, Submissions Publishing allows you to generate GCC eCTD v1.1 DTD compliant XMLs for submission to the Gulf Cooperation Council. Vault can validate these submissions in accordance with GCC eCTD Validation Criteria Profile v1.4.

About Node Extensions & Study Tagging Files

You can create GCC submissions that contain both Study Tagging Files (STFs) and node extensions. If your submission contains both node extensions and STFs, they must exist in separate content plan sections. If your submission contains an STF XML, Vault creates STFs instead of node extensions.

Copying a Content Plan for GCC Submissions

When copying a content plan from another submission, Vault removes all country-specific data with the exception of the STF Content Plan Item record to support other regions that accept STFs. In order for the publishing process to work correctly for copied submissions, you must set the Continuous Publishing and Continuous Validation fields to Yes on all Content Plan Items.

Viewing & Managing Submission Administrative Information

Vault supports viewing Submission Administrative Information for GCC v1.0 and v1.1 DTDs. You can also view and manage Submission Administrative Information for GCC v1.1 DTDs. See Managing Submission Administrative Information for details.