Enable CIOMS II Line Listings

Learn how to update your Vault’s configuration to enable CIOMS II line listings.

About the Feature

Support for standalone CIOMS II line listings reports was added in 22R2. The CIOMS II standalone report supports masking and can optionally include additional information beyond that required by regulations.

Once you enable this feature, Create CIOMS II Reports describes how to create and generate CIOMS II line listings.

If your Vault was provisioned before 22R2, you must perform the following configuration changes to enable this feature.

24R3 Update: Additional Filters for CIOMS II Aggregate Report

With the 24R3 release, CIOMS II reports support the flexibility to generate a wide variety of reports presented in the standard CIOMS II line listing format, including filters for report type, seriousness, relatedness, expectedness, and expectedness source. Users can also specify certain countries to include in all CIOMS II reports, whether generated using the original CIOMS II logic or the additional filters. See (24R3) Configure for Additional Filters for CIOMS II Aggregate Report for more details.

Activate the CIOMS II Object Type

  1. Go to Configuration > Objects > Aggregate Report.
  2. Select Object Types.
  3. Select the CIOMS II object and set its status to Active.

Activate the CIOMS II Document Type

  1. Go to Configuration > Document Types.
  2. From the Base Document, navigate to Aggregate Reports > Summary Tabulation.
  3. Select the CIOMS II Document Type and set its status to Active from the Actions menu.

Add CIOMS II as a Navigation Tab

The CIOMS navigation tab is not included by default in the Vault Safety 22R2 template. To enable CIOMS II in a Vault, you must add a navigation tab for CIOMS II.

In Admin, go to Configuration > Tabs, and add a CIOMS II sub-tab under Aggregate Reports:

Adding CIOMS II as a Navigation Tab

Update User Permissions to Access CIOMS II

You must update permission sets for users who need access to view and create CIOMS II reports. With default configurations, this is the Safety Writer permission set, but this may vary depending on your configuration. These permissions are not included by default in the Vault Safety 22R2 template.

  1. Add access to the CIOMS II navigation tab for each relevant permission set.
  2. Add access to the CIOMS II object type for each relevant permission set.

Add Comments Field to Aggregate Report Layout

The Comments Field must be on the Aggregate Report Detail Page Layout, allowing users to customize their reports with optional fields.

Go to Configuration > Objects > Aggregate Report > Layouts > Aggregate Report Detail Page Layout, and ensure the Comments Field is on the layout.

If you must add the field, ensure to update the appropriate Permission Sets to grant access to Edit this field.

Add CIOMS II Line Listing Template

If your Vault does not have the template for CIOMS II Line Listings, you must add these templates to be able to generate CIOMS II tabulations. Vaults created after 22R2 include these templates by default. For Vaults created before 22R2, you must add these templates.

The following section describes how to add this template to your Vault.

Upload Template: CIOMS II Line Listing

  1. Go to Business Admin > Documents & Binders.
  2. Expand the folders to Template > Aggregate Summary Tabulation > CIOMS II Line Listing.
  3. Select Create, and then select Document Template.
  4. Specify the following details for the template document:
    • Type: Select Basic Document Template.
    • Label: Enter CIOMS II Line Listing.
    • Name: This field should be automatically updated. Ensure the name has been updated to cioms_ii_line_listing__c. The template name must match the Document Type Template name or the report will not generate from the template.
    • Status: Ensure this field is set to Active.
  5. Under More Information, upload the CIOMS II template. Download the following file, and then attach it as the template document: II - Interval Line Listing of Adverse Drug Reactions
  6. Select Save.

Result

Your Vault contains the template for CIOMS II Line Listings.

(24R3) Configure for Additional Filters for CIOMS II Aggregate Report

To allow users to filter the CIOMS II report by country as well as utilize additional filters using the standard CIOMS II line listing format, you must update the Aggregate Report object layout and layout rules.

Update the Aggregate Report Layout

Update the Aggregate Report object layout in the following ways:

  1. Insert a new related object section for the Aggregate Report Country > Country object with the option to Create record in pop-up dialog.
  2. Add the following fields to the Details section of the layout, below the States to Include field:
    • Original CIOMS II Logic
    • Report Type
    • Case Serious
    • Case Relatedness
    • Case Expectedness
    • Expectedness Source

Create a Layout Rule for Countries

Create a layout rule for the Countries section:

  1. Navigate to the Layouts tab, and select the appropriate layout.
  2. Select Layout Rules.
  3. On the Layout Rules list page, select Create.
  4. Add a Layout Rule with the following configuration:
    • Label: “Country Filter”
    • IF this Layout Rule Expression is TRUE: object_type__vr.name__v != 'CIOMS II'
    • Apply the following display effects: Hide > Sections > Interval Dates
  5. Select Save.

Create a Layout Rule for Original CIOMS II Logic

Create a layout rule for the Original CIOMS II Logic field:

  1. Navigate to the Layouts tab, and select the appropriate layout.
  2. Select Layout Rules.
  3. On the Layout Rules list page, select Create.
  4. Add a Layout Rule with the following configuration:
    • Label: “Use Original CIOMS II Logic”
    • IF this Layout Rule Expression is TRUE: (original_cioms_ii_logic__v) || isBlank(original_cioms_ii_logic__v)
    • Apply the following display effects: Hide > Fields > Report Type, Case Serious, Case Relatedness, Case Expectedness, Expectedness Source
  5. Select Save.