About the Submission Dossier

When you create or edit a submission task, you can select a volume name. The volume is a controlled folder used to organize documents in a dossier in the exported ZIP file. For example, you could have one volume named Clinical and another named Laboratory. Then, the submitted dossier would have a folder named Clinical that contained all the deliverables from tasks that specified the Clinical volume, and another folder for the Laboratory documents.

Regulatory Administrators can create controlled folders for submission templates (for use by any submission project created from that template), and Regulatory Leads can create controlled folders for specific submission projects. Use the Folders page for the submission project or submission template to create controlled folders (see Creating a Controlled Folder).

You can view the contents of any controlled folder by clicking its name in the Volume column on the Schedule tab. You can view the entire dossier on the Folders page for the submission project.

Regulatory Users typically complete their tasks by adding documents to the Deliverables page for the task. You can use the Sync Submission Dossier command on the Schedule tab to copy those documents to the controlled folder assigned to that task.

When Regulatory Leads are ready to publish the dossier, such as when sending the submission dossier to the regulatory authority, the dossier should be frozen so that no documents can be added to it. All documents in the folders must already be released. These steps need to be performed for each controlled folder:

1. View the Basic Information page for the folder.
2. Click Release from the Actions menu or toolbar.

If you subsequently need to revise existing documents or add documents to a controlled folder, you must revise the folder structure.