When working with HSA regulatory submissions, Submissions Publishing allows you to generate SG eCTD XSD 1.0 compliant XMLs for submission to HSA (Singapore). Vault can validate these submissions in accordance with the HSA SG 1.0 Validation Criteria Version.
Note: This feature is only available on RIM Submissions Publishing Vaults.
About Node Extenstions & Tagging Files
The SG eCTD specification supports both node extensions and Study Tagging Files (STFs) in the same submission. If your submission contains both node extensions and STFs, they must exist in separate content plan sections.
Copying Content Plan for SG 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 SG 1.0 XSDs. You can also manage Submission Administrative Information for SG 1.0 XSDs. When you manage Submission Administrative Information for Thai submissions, the viewer displays additional fields based on the text in the Sequence Description. See Managing Submission Administrative Information for details.