Impact Assessment Reports (RIM)

Reports in RIM Registrations Vaults can help you to determine the impact of proposed changes related to an event. You can bulk create submissions, activities, and regulatory objectives from any of these reports.

There are two types of Impact Assessment Reports: standard and configurable. You can tell whether your Vault uses standard Impact Assessment Reports or configurable Impact Assessment Reports based on the fields available in the dialog when you launch the report.

Using Standard Impact Assessment Reports

The following standard one-click reports are available in RIM Registrations Vaults:

Product Impact Assessment Report (RIM Registrations)
Lists all registrations related to the Product (drug_product__v) or Manufacturer records described in the Event record. Learn more.
Active Substance Impact Assessment Report (RIM Registrations)
Lists all registrations related to the Active Substance or Manufacturer described in the Event record.
Packaging Impact Assessment Report (RIM Registrations)
Lists all registrations related to the Packaging, Packaging Site, or Shelf Life changes described in the Event record.
Inactive Ingredient Impact Assessment Report (RIM Registrations)
Lists all registrations related to the Inactive Ingredient or Manufacturer described in the Event record.
Indication Impact Assessment Report (RIM Registrations)
Lists all registrations related to the Indication changes described in the Event record.
Clinical Study Assessment Report (RIM Registrations)
Lists all registrations related to the Clinical Study or Study Site changes described in the Event record.

How to View Reports

To open a standard impact assessment report for a specific event:

  1. Navigate to the Event record.
  2. From the Actions menu, choose Impact Assessment Report. You’ll only see this option if the Event record has at least one related join record, for example, an Event Packaging record.
  3. In the dialog, choose the data you want to include. The Event record needs to be associated with the appropriate records, for example, opening the Inactive Ingredient Impact Assessment requires that the event is associated with at least one Inactive Ingredient record.
  4. Click Run.

Using Configurable Impact Assessment Reports

Your Admin defines the report types that are available for configurable Impact Assessment Reports in your Vault.

To open a configurable impact assessment report for a specific event:

  1. Navigate to the Event record.
  2. From the Actions menu, choose Impact Assessment Report. This option is available for all Event records, regardless of related join records.
  3. In the dialog, select the Report Type and the Report Template to use. The options you see are defined by your Admin.
  4. Fill in any required report prompts. Vault may populate some values automatically based on the records associated with the Event record.
  5. Click Continue.

Working with Reports

Vault creates a copy of the report template that you selected in the dialog, saves any values you entered in the Impact Report Options dialog as filters, and assigns you the Viewer role. The copied report’s name is based on the Event record from which you initiated the Impact Assessment Report, and the report description includes the Event record ID. After you’ve made any changes, click Save.

If you re-run the report from the same Event record using the same report template, Vault overwrites the saved report based on the input from the Event record, rather than creating a duplicate report. You can still access the report from the Reports tab.

After you save the report, you can select Create Related Records from the report’s Actions menu. When you start the Create Related Records wizard from the report, Vault populates the Event field in the wizard with the Event record ID from which you started the Impact Assessment Report.

When you run the Create Related Records wizard from this report, Vault only carries forward data related to the Event record to any Regulatory Objective or Submission records created from the wizard. If you change the filters in your report copy to include data that is not related to the event, Vault will not carry this data forward.

Objects & Medical Decive Support

In Vaults created after the 19R1 release, the following objects are relabeled to support medical devices. For Vaults cerated prior to 19R1, Admins must update the standard objects to support medical devices.

  • The Product (product__v) object is Product Family.
  • The Drug Product (drug_product__v) object is Product.
  • The Product Detail (product_detail__v) object is Product Variant.