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

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:

  1. Go to Analytics > Reports and open the Annex H report.
  2. 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.
  3. Generate the PSMF document. For more information, see Generate PSMF Documents from Vault Reports.