Regulatory objectives sometimes require multiple submissions to get approved, often with similar or identical details. To reduce data entry, Vault allows users to enter all required details on a Regulatory Objective record, and then copy the related records from the Regulatory Objective record to a Submission record.
Note: This feature is only available on RIM application Vaults and requires an Admin to configure it.
How to Pull Regulatory Objective Data to Submissions
To pull Regulatory Objective details to Submission join records:
- Ensure all relevant details are entered on the Regulatory Objective record.
- Open the Submission object record detail page and expand the Regulatory Objective section.
- Click Add and select the Regulatory Objective record in the dialog to relate it to the Submission.
- Click OK to return to the Submission object record detail page.
- Open the Submission record’s Actions menu and select Pull Objective Data.
- Vault creates the new Submission join records asynchronously from the related Regulatory Objective. When record creation is complete, you’ll receive a notification from Vault with details about record creation.
You must wait for Vault to complete record creation on one Submission before you can pull Regulatory Objective details to another Submission record.
Supported Objects
When you pull Regulatory Objective details to a Submission record, Vault can create records for the Submission join objects below. Vault determines the object types for the created records and populates key fields with values from the Regulatory Objective join records based on your Admin’s configuration.
| Regulatory Objective Join | Submission Join |
|---|---|
| Regulatory Objective Active Substance | Submission Active Substance |
| Regulatory Objective Clinical Study | Submission Clinical Study |
| Regulatory Objective Inactive Ingredient | Submission Inactive Ingredient |
| Regulatory Objective Indication | Submission Indication |
| Regulatory Objective Nonclinical Study | Submission Nonclinical Study |
| Regulatory Objective Packaging | Submission Packaging |
| Reg Objective Packaging Characteristic | Submission Packaging Characteristic |
| Regulatory Objective Product | Submission Product |
| Reg Objective Product Characteristic | Submission Product Characteristic |
| Reg Objective Product Classification | Submission Product Classification |
| Regulatory Objective Shelf Life and Storage | Submission Shelf Life and Storage |
| Regulatory Objective Site Contact | Submission Site Contact |
| Regulatory Objective Site Organization | Submission Site Organization |
| Regulatory Objective Site Role | Submission Site Role |
Use Case: Submission Packaging for Medical Devices
When creating a Submission Packaging record from a Regulatory Objective Packaging record for a medical device, Vault would populate the following fields:
- DI Contained Within
- Finished Product Code
- Finished Product Manufacturer
- Packaging
- Packaging Site
- Packaging UDI-DI
- Product
- Product Variant
- Shelf Life
- Site Role
- Site Product Type
- Submission
- Any additional custom fields configured by your Admin on both objects
Related Permissions
The Pull Objective Data action requires that your security profile grant Create permission on the objects you’re creating, for example, Submission Product. Vault checks for the required permissions during the asynchronous record creation phase of the process. You may be able to view the action even if it is not available to you. Any field-level security your Admin has configured on these objects may impact record creation as well.
You must also have Read permission on the source Submission record from which you initiate the wizard and the records from which the wizard pulls data, for example, Regulatory Objective Product. If the objects use Dynamic Access Control, you must have at least the Viewer role on the specific records. If your Vault uses field-level security, you must have Read permission on the fields from which Vault pulls data.