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.
Configuring the Pull Objective Data Action
To enable Vault to pull any Regulatory Objective join records to a Submission record asynchronously, add the Pull Objective Data user action to any Submission object lifecycle state.
Configuring Object Access
To ensure users can create Regulatory Objective join records and access the Submission join records that Vault creates, update the Regulatory Objective and Submission object page layouts to add related object sections for each supported join object.
About Record Naming
If you configure system-managed naming on the Submission join objects, Vault names newly-created records based on your defined patterns. When setting up system-managed naming, ensure that your naming pattern doesn’t exceed 128 characters or record creation could fail. If you don’t configure system-managed naming, Vault will name records based on key fields.
About Object Type Mapping
Vault uses object type mapping to determine which object types to use, depending on the Registration object types selected in the wizard. This is especially important for registrations with a combination of drug product, medical device product, and packaging details.
To do this, Vault checks for active Object Type Mapping records you’ve created and, based on that mapping data, selects the object types. If there are no active records, the wizard automatically selects the target object type by comparing the Names of the source and target object types (for example,
device_intended_use__v). If the Name values do not match, Vault prompts the user to select the target object type.
About the Object Type Mapping Object
The Object Type Mapping object supports customers who want to manually create submissions or regulatory objectives for both drug products and medical device products. See Configuring Object Type Mapping for Registrations for more information and a sample set of mappings.
Configuring Matching Custom Fields
Vault can copy custom field values from Regulatory Objective join records to the corresponding Submission join records for the following field types: Picklist, Object, Date, DateTime, Yes/No, Text, and Number.
In order for Vault to copy matching custom fields, you must configure custom fields with matching names and field types on both objects. You should not configure entry criteria on any matching custom fields on the Submission join objects, or Vault may not be able to create new records. If you have object types enabled on any of these objects, configure matching custom fields for all object types.
Configuring User Permissions
In order for users to access and use the Pull Objective Data action, you must ensure that their security profiles are configured correctly. Users need:
- Create permission on the objects the action creates, for example, Submission Product
- Read permission on the source Submission record from which they start the action, as well as the records from which the wizard pulls data, for example, Regulatory Objective Product
- If the objects use Dynamic Access Control, users need at least the Viewer role on the specific records
- If your Vault uses field-level security, users must have Read permission on the fields from which Vault pulls data