Using the Safety-RIM Vault Connection, organizations with both a Safety Vault and RIM Submissions Vault can exchange data from your RIM Submissions Vault to your Safety Vault, providing a common set of data against which to record Safety Cases.
The Safety-RIM connection transfers, creates, and updates the following records in your Safety Vault based on updates made to corresponding records in your RIM Vault:
- Organization (of type Registration Holder)
- Product
- Product Constituent
- Product Family
- Product Family Product
- Product Family Substance
- Product Registration (of types Marketed Drug Product Registration and Marketed Device Product Registration)
- Product Variant
- Substance
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
How the Safety-RIM Vault Connection Works
When you create a new record, update an existing record, or delete a record in your RIM Vault, the corresponding record in Vault Safety is created, updated, or marked for deletion. The following table displays the records in RIM with the corresponding records in Vault Safety:
| RIM Object Record | Vault Safety Object Record |
|---|---|
organization__rim |
organization__v of object type registration_holder__v (1.0 Organization) |
product__v |
product_family__v (2.0 Product Family) |
drug_product__v |
product__v (3.0 Product) |
product_classification__v |
product__v (3.1 Product - FDA Product Code Update) |
product_pharmaceutical_product__rim |
product_family_product__v (4.0 Product Family Product) |
product_detail__v |
product_variant__v (5.0 Product Variant) |
product_component__rim |
product_constituent__v (6.0 Product Constituent) |
drug_substance__v |
substance__v (7.0 Substance) |
product_active_substance__rim |
product_family_substance__v (8.0 Product Family Substance) |
registration__rim |
product_registration__v (9.0 Product Registration) |
medicinal_product_registration__v |
product_registration__v (9.1 Product Registration - Med Product Update) |
registered_regulatory_text__v |
product_alias__v (10.0 Product Alias) |
Generating the PSMF Annex H Document
You can use the standard Annex H report to generate the PSMF Annex H document in your SafetyDocs Vault using product registration data received from your RIM Vault. To do this:
- Go to Analytics > Reports and open the Annex H report.
- Review the report and identify any missing field data.
- If applicable, populate those fields on the appropriate records.
- If you update any fields, Refresh the report.
- Generate the PSMF document. For more information, see Generate PSMF Documents from Vault Reports.
Note: The Annex H report automatically excludes any Product Registrations for Countries that do not have a valid ISO country name.