The Object Type Mapping object supports customers who want to manually manage registered details or create registrations in bulk for both drug products and medical device products. This object allows you to configure which object types to use for particular registered details, such as Registered Product records, depending on the Registration Type the user selects in either wizard. Object Type Mapping records are also used when creating a Submission record from the Submission Wizard to determine the Submission object type to use based on the Application’s object type.
Note: In some cases, Vault can handle this process automatically in the absence of Object Type Mapping records. See Automatic Mapping below.
This sample mapping file provides a typical set of mappings for drug and medical device object types. You may create similar mappings for custom source registration object types or custom object types on target registered detail objects.
Your Vault should have a set of object types defined on the submission join objects (such as Submission Product) that correspond to the registration join objects (such as Registered Product) defined as targets in the Object Type Mapping records.
Vault automatically determines object type mappings for the below processes in Vaults created on or after the indicated Vault product release:
- Managing Registered Details (21R3)
- Pulling Regulatory Objective Data to Submissions (22R1)
- Creating Related Records (22R1)
- Bundling Activities & Regulatory Objectives (22R2)
- Splitting Regulatory Objectives (22R2)
- Bulk Creating Registrations (23R1), including Active Substance, Investigational, Manufacturing Site, and Product registrations