Enable Standardized and Custom MedDRA Queries

Learn how to update your Vault’s configuration to enable standardized and custom MedDRA queries (SMQs and CMQs).

About the Feature

Standardised MedDRA queries (SMQs) and configurable queries were added in Vault Safety 20R1. Upgraded Vaults must perform the following configuration changes to enable this feature.

Use MedDRA Queries describes how use SMQs and set up CMQs, once you enable this feature.

Import MedDRA SMQs

To add SMQs to your Vault, you must import a MedDRA dictionary. If your Vault already has an active MedDRA dictionary that was imported prior to 20R1, you must import the dictionary again for the SMQs to appear. Import Standard MedDRA Queries provides instructions.

Configure the MedDRA Query Object

The MedDRA Query object is new for this feature. You must configure layouts and layout rules for this object. To edit the MedDRA Query object, in the Admin area, go to Configuration > Objects > MedDRA Query.

Fields

On the MedDRA Query > Fields tab, update the following fields:

Field Change
Hierarchical Display in Lists/Hover: Yes
MedDRA Versions Display in Lists/Hover: Yes

Layout

On the MedDRA Query > Layouts tab, open MedDRA Query Detail Page Layout, and then edit the layout to match the following sections.

Details Section

Update the Details section with the following settings:

  • Section Layout: One Column
  • Fields:
    • Organization
    • Name
    • Parent Query
    • Root Query
    • Level
    • Hierarchical
    • Description
    • MedDRA Versions
    • space

Sub-Queries Section

Insert a Sub-Queries section with the following settings:

  • Type: Related Object: MedDRA Query
  • Creation Option: Create record in pop-up dialog
  • Columns:
    • Name
    • Hierarchical

MedDRA Terms Section

Insert a MedDRA Terms section with the following settings:

  • Type: Related Object: MedDRA Criteria
  • Creation Option: Create record in pop-up dialog
  • Filter: MedDRA Criteria Type equals MedDRA Query Criteria
  • Columns:
    • Name
    • MedDRA Term
    • Scope

Layout Rules

Go to MedDRA Query > Layouts > MedDRA Query Detail Page Layout, and then add the following layout rules:

Rule Label Hide the following Page Layout Items IF this Layout Rule Expression is TRUE
Parent Query Parent Query isBlank(parent_query__vr.name__v)
Root Query Root Query isBlank(root_query__vr.name__v)
Organization Organization not(isBlank(parent_query__vr.name__v))
New Record Level status__v != 'active__v' &&
status__v != 'inactive__v'
Hierarchical MedDRA Terms hierarchical__v
Not Hierarchical Sub-Queries not(hierarchical__v)
Workflow Timelines Workflow Timeline not(isBlank(name__v))
MedDRA Versions MedDRA Versions isBlank(api_name__v)

Update the MedDRA Criteria Object

You must add layouts and layout rules for the MedDRA Criteria object. To edit the MedDRA Criteria object, in the Admin area, go to Configuration > Objects > MedDRA Criteria.

Layout

On the MedDRA Criteria > Layouts tab, edit the MedDRA Query Criteria Detail Page Layout to match the following sections.

Details Section

Update the Details section with the following settings:

  • Section Layout: One Column
  • Fields: Add the following fields:
    • MedDRA Query
    • MedDRA Term
    • Scope
    • MedDRA Versions
    • space

System Information Section

Insert a System Information section with the following settings:

  • Section Layout: Two Columns
  • Fields: Add the following fields:
    • Last Modified Date
    • Last Modified By
    • SMQ Code
    • space
    • space
    • Created Date
    • Created By
    • Organization
    • API Name

Layout Rules

Go to MedDRA Criteria > Layouts > MedDRA Query Criteria Detail Page Layout > Layout Rules, and then add the following layout rules:

Rule Label Hide the following Page Layout Items IF this Layout Rule Expression is TRUE
New Record
  • Type: Sections
  • Value: System Information
 status__v != 'active__v' && status__v != 'inactive__v'
Workflow Timeline
  • Type: Sections
  • Value: Workflow Timeline
 not(isBlank(name__v))
MedDRA Versions
  • Type: Fields
  • Value: MedDRA Versions
 isBlank(api_name__v)

Configure Reports

To enable users to run MedDRA SMQ/CMQ reports, you must configure report types and report views, and then add those reports to your Vault.

Standard Report Types

Configure the following standard report types on the Configuration > Report Types page.

Case Adverse Events (SMQ/CMQ)

  • Report Label: Case Adverse Events (SMQ/CMQ)
  • Description: Case Adverse Events for SMQ/CMQ searches
  • Primary Reporting Object: Case Adverse Event
  • Related Objects:
    • Case (Parent) ↑
    • Event (MedDRA) ↑

Case Adverse Events (SMQ/CMQ) Report Type

MedDRA Terms

  • Report Label: MedDRA Terms (SMQ/CMQ)
  • Description: MedDRA Terms for SMQ/CMQ searches
  • Primary Reporting Object: MedDRA Criteria
  • Related Objects:
    • MedDRA Query ↑
    • MedDRA Term ↑

MedDRA Terms Report Type

Standard Report Views

Configure the following report views on the Configuration > Report Views page.

Case Adverse Events (SMQ/CMQ)

Add a Case Adverse Events (SMQ/CMQ) standard report type with the following settings:

  • Report Label: Case Adverse Events (SMQ/CMQ)
  • Report Type: Case Adverse Event
  • Conditional Fields: N/A
  • Filters: Case > Case Type in (Case, Imported Case)

MedDRA Terms Report View

MedDRA Terms

Add a MedDRA Terms standard report type with the following settings:

  • Report Label: MedDRA Terms (SMQ/CMQ)
  • Report Type: MedDRA Criteria
  • Conditional Fields: N/A
  • Filters: MedDRA Criteria > MedDRA Criteria
    Type equals MedDRA Query Criteria

MedDRA Terms Report View

Multi-Pass Report Type

Configure the following SMQ/CMQ Multi-Pass Report on the Configuration > Report Types page:

  • Report View: Case Adverse Events (SMQ/CMQ)
  • Relationships: Add a relationship with the following settings:
    • Select new entity: MedDRA Terms (SMQ/CMQ)
    • Match Case Adverse Events (SMQ/CMQ) on: MedDRA > PT Code
    • Match new entity on: MedDRA > PT Code
    • Join type: Inner

Add Reports to Your Vault

To search for Cases that match SMQs or CMQs, you must add reports to your Vault.

Go to the Vault view, and then add the following reports on the Reports tab.

Search by Product Using Root Query

Add an SMQ/CMQ Search by Product Using Root Query report with the following settings:

  • Report Label: SMQ/CMQ Multi-Pass Report
  • Report Type: SMQ/CMQ Search
  • Columns: Add the following columns:
    • Case > Name
    • Case > Serious
    • Case > Expected
    • Case Adverse Event > Event (MedDRA)
    • MedDRA Query > Name
    • MedDRA > Term (Code)
  • Prompts: Add the following prompts:
Prompt Alias Field Condition
Organization Case > Organization equals
Primary Suspect Product Case > Product equals
Root-Level SMQ/CMQ MedDRA Query > Root Query equals
Query Scope MedDRA Criteria > Scope in

Search by Product Across Multiple Queries

Add an SMQ/CMQ Search by Product Across Multiple Queries report with the following settings:

  • Report Type: SMQ/CMQ Search
  • Columns: Add the following columns:
    • Case > Name
    • Case > Serious
    • Case > Expected
    • Case Adverse Event > Event (MedDRA)
    • MedDRA Query > Name
    • MedDRA > Term (Code)
  • Prompts: Add the following prompts:
Prompt Alias Field Condition
Organization Case > Organization equals
Primary Suspect Product Case > Product equals
SMQs/CMQs MedDRA Criteria > MedDRA Query in
Query Scope MedDRA Criteria > Scope in

Search by Study Using Root Query

Add an SMQ/CMQ Search by Study Using Root Query report with the following settings:

  • Report Type: SMQ/CMQ Search
  • Columns: Add the following columns:
    • Case > Name
    • Case > Serious
    • Case > Expected
    • Case Adverse Event > Event (MedDRA)
    • MedDRA Query > Name
    • MedDRA > Term (Code)
  • Prompts: Add the following prompts:
Prompt Alias Field Condition
Organization Case > Organization equals
Study Case > Study equals
Root-Level SMQ/CMQ MedDRA Query > Root Query equals
Query Scope MedDRA Criteria > Scope in

Search by Study Across Multiple Queries

Add an SMQ/CMQ Search by Study Across Multiple Queries report with the following settings:

  • Report Type: SMQ/CMQ Search
  • Columns: Add the following columns:
    • Case > Name
    • Case > Serious
    • Case > Expected
    • Case Adverse Event > Event (MedDRA)
    • MedDRA Query > Name
    • MedDRA > Term (Code)
  • Prompts: Add the following prompts:
Prompt Alias Field Condition
Organization Case > Organization equals
Study Case > Study equals
SMQs/CMQs MedDRA Criteria > MedDRA Query in
Query Scope MedDRA Criteria > Scope in

Update Permission Sets

You must update permission sets to grant Admins access to modify MedDRA Queries, and users access to view them.

To edit permission sets, go to Users & Groups > Permission Sets. Go to the Objects tab on a permission set to modify object permissions.

Administrator Permission Set

Update the Administration permission set to enable the following permissions for the MedDRA Criteria > MedDRA Query Criteria object:

  • Read
  • Create
  • Edit
  • Delete

User Permission Sets

Update the following permission sets to enable the Read permission for the MedDRA Criteria > MedDRA Query Criteria object:

  • Case Distribution Actions
  • Case Entry Actions
  • Case Intake Actions
  • Case Review Actions
  • Safety Operations Actions
  • Safety Writer
  • Submission Actions