Enable PSUR Tabulations and CIOMS II Line Listings

Learn how to update your vault's configuration to enable PSUR cumulative tabulations and CIOMS II line listings.

Last Updated Aug 13, 2021

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About the Feature

Support for PSUR and CIOMS II line listings reports was added in 20R2 and further enhancements to the report templates were added in 21R1. Reports can be generated based on drugs, studies, and/or active substances.

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

Path to Configure PSUR

Vaults deployed in 21R1 include the latest template configuration already, while vaults deployed in an earlier release must perform additional configuration.

Vaults Deployed In 21R1 or Later

• Add PSUR as a Navigation Tab
• Update User Permissions to Access PSUR

Vaults Deployed in 20R3 or Earlier

• Add PSUR as a Navigation Tab
• Update User Permissions to Access PSUR
• Updated in 21R1: Add the CIOMS II Line Listings Template
• Updated in 21R1: Add the Cumulative Summary of Tabulations of Adverse Events Template

Add PSUR as a Navigation Tab

The PSUR navigation tab is not included by default in the Vault Safety 20R2 template. To enable PSUR in a vault, an administrator must add a navigation tab for PSUR.

In Admin, go to Configuration > Vault Navigation > Tabs, and add a PSUR sub-tab under Aggregate Reports:

Adding PSUR as a Navigation Tab

Update User Permissions to Access PSUR

An administrator must update permission sets for users who need access to view and create PSUR 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 20R2 template.

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

Add Templates for PSUR Cumulative Summaries and CIOMS II Line Listings

If your vault does not have templates for PSUR Cumulative Summaries and CIOMS II Line Listings, you must add these templates to be able to generate PSUR tabulations. In vaults created after 21R1, these templates are included by default. For vaults created prior to 21R1, an administrator must add these templates.

The following sections describe how to add these templates to your vault.

Updated in 21R1: Add the CIOMS II Line Listing Template

Note The PSUR CIOMS II Line Listing template has been updated as of 21R1 to display the Time to Onset. This template must be replaced in vaults originally deployed prior to 21R1.

1. On the Business Admin tab, go to Documents & Binders.
2. Expand Template > Aggregate Summary Tabulation > Interval Line Listings of Serious Adverse Reactions.
   If the CIOMS II Line Listing Template is in your vault, it is listed.

   

   PSUR CIOMS II Template

3. Perform one of the following action sequences to either add or update the CIOMS II template:
   • If the CIOMS II Line Listing Template for PSUR Reports template is listed, update the existing template:
     1. Select Interval Line Listings of Serious Adverse Reactions > CIOMS II Line Listing Template for PSUR Reports (psur_ciomsii_line_listings__c).
     2. Select Edit.
     3. Download the CIOMS II Line Listing Template for PSUR Reports .
     4. Select Upload File under the More Information section.
     5. Select the CIOMS II Line Listing for PSUR Reports Template from your file browser.
     6. Select Save.
   • If the CIOMS II Line Listing Template for PSUR Reports template is not listed, add the template:
     1. Under Interval Line Listings of Serious Adverse Reactions, select Create > Document Template.
     2. Specify the following details for the template document:

        Setting	Value
        Type	Basic Document Template
        Label	CIOMS II Line Listing Template for PSUR Reports
        Name	psur_ciomsii_line_listings__c
        Status	Active
        Template Document	Download the following file, and then attach it as the template document: CIOMS II Line Listing Template for PSUR Reports

     3. Select Save.

Updated in 21R1: Add the Cumulative Summary of Tabulations of Adverse Events Template

Note The PSUR Cumulative Summary Tabulations of Adverse Events template has been updated as of 21R1 to display the MedDRA Preferred Term section label. This template must be replaced in vaults originally deployed prior to 21R1.

1. On the Business Admin tab, go to Documents & Binders.
2. Expand Template > Aggregate Summary Tabulation > PSUR - Cumulative Summary of Tabulations of Adverse Events (local templates only).
   If the PSUR - Cumulative Summary of Tabulations of Adverse Events Template is in your vault, it is listed.

   

   PSUR Summary Tabulation Template

3. Perform one of the following action sequences to either add or update the CIOMS II template:
   • If the PSUR - Cumulative Summary of Tabulations of Adverse Events Template template is listed, update the existing template:
     1. Select PSUR - Cumulative Summary of Tabulations of Adverse Events Template (psur_summary_tabulations_of_ae__c).
     2. Select Edit.
     3. Download the PSUR Cumulative Summary Tabulations of Adverse Events .
     4. Select Upload File under the More Information section.
     5. Select the PSUR Cumulative Summary of Tabulations of Adverse Events Template from your file browser.
     6. Select Save.
   • If the PSUR - Cumulative Summary of Tabulations of Adverse Events Template template is not listed, add the template:
     1. Under PSUR - Cumulative Summary of Tabulations of Adverse Events (local templates only), select Create > Document Template.
     2. Specify the following details for the template document:

        Setting	Value
        Type	Basic Document Template
        Label	PSUR Cumulative Summary Tabulations of Adverse Events
        Name	psur_summary_tabulations_of_ae__c
        Status	Active
        Template Document	Download the following file, and then attach it as the template document: PSUR Cumulative Summary Tabulations of Adverse Events

     3. Select Save.

Related Feature Enablement

Enable Filter Cases by Approval Date in Aggregate Reports

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