Exporting a TMF in Vault requires you to create a “master file” binder for the study, for each of the study countries, and for each site. Bulk creation helps you accomplish this in a single action, rather than manually creating each of these binders. You can initiate this action for an entire study, or for a specific study country and its sites.
Any time that a master file binder already exists for a country or site, Vault automatically skips creation for that record, ensuring that you don’t accidentally create duplicate binders. Once creation is complete, Vault initiates auto-filing on the new binders so that the complete set of master file binders is ready for review and export. Note that this action creates binders for study countries and sites with an inactive status. This ensures that all study countries and sites are represented by a master file binder at the time of export.
How to Bulk Create Binders
To bulk create master file binders:
- Open the Study or Study Country record from Admin > Business Admin or a custom object tab. Note that the study cannot be in Archived status.
- Choose Create Study Binders from the Actions menu.
- Select binder templates to use for each level. If you’re creating from a study, you’ll select a template for the study, country, and site level. If you’re creating from a study country, you’ll only select a country and site level template.
- Click Continue to start the bulk creation process. Note that Vault ignores any planned documents in your selected template.
- When binder creation is complete, a notice will appear in your Notifications page and Vault will send you an email.
Related Permissions
|
Type |
Permission Label |
Controls |
|
Security Profile |
Various |
Ability to access record details and list pages for the Study and Study Country objects; in Vaults with custom object tabs for these objects, you need permission to access the tabs. In Vaults that don't include the custom tabs, you'll need to have access to Admin: Business Admin. |
|
Document Type |
Create Binder |
Access to create binders with this document type; you need this permission on the following standard document types: Study Level File, Study Country Level File, Study Site Level File |
About the Scheduled Job
Vault uses the job scheduler to manage bulk binder creation. The Create Study Binders job appears in the Admin > Operations tab, but Admins cannot modify the job definitions or access any of the scheduled job management options, like Start Now and Cancel.
How to Enable
This feature is automatically available. However, you can only bulk create binders if their document type uses document name defaulting.