When working with World Health Organization regulatory submissions, Submissions Publishing allows you to generate WHO-PQT (v1.1 guidance) (DTD v1.0) compliant XMLs. Vault can validate these submissions in accordance with the WHO-PQT 1.1 Validation Criteria Version.
Note: This feature is only available on RIM Submissions Publishing Vaults.
About Product Types and Product Subtypes
When creating an WHO Application, you must select a Product Type and optionally a Product Subtype. Depending on the Product Type selected, ensure the regional.xml is valid. The Product Type and Product Subtype fields should be added to the Application and Submission objects to allow a user to select the Product Type and Subtype for a given Submission.
About Node Extensions
WHO Submissions require node extensions instead of Study Tagging Files (STFs). To publish node extensions, you’ll need to do the following:
Set the Create Node Extensions field on the Submission record to Yes Define node extensions on the Content Plan by setting the XML Element Name field to node-extension Enter a value in the XML Title field on the Content Plan
Copying a Content Plan for WHO 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 WHO submissions, you must delete the STF Content Plan Item. You’ll also need to set the Continuous Publishing and Continuous Validation fields Yes on all Content Plan Items.
Viewing & Managing Submission Administrative Information
Vault supports viewing Submission Administrative Information for WHO 1.1 DTDs. You can also manage Submission Administrative Information for WHO 1.1 DTDs.