When working with CA regulatory submissions, Submissions Publishing allows you to generate CA eCTD v2.2 XSD compliant XMLs for submission to Health Canada. Vault can validate these submissions in accordance with CA eCTD Validation Criteria Profile v5.1.
Note: This feature is only available on RIM Submissions Publishing Vaults.
About Node Extensions & Study Tagging Files
The CA eCTD specification supports both Study Tagging Files (STFs) and node extensions in the same submission. 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 CA Submissions
When copying a content plan from a US submission, Vault removes all US-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 CA 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 CA v0.9 and v1.0 XSDs. You can also view and manage Submission Administrative Information for CA v 2.2 XSDs. See Managing Submission Administrative Information for details.