Use MedDRA Queries

Use queries to find patterns in previously processed Cases and discover new adverse events.

About MedDRA Queries

Vault Safety supports Standard MedDRA Queries (SMQs), Custom MedDRA Queries (CMQs), and MedDRA Query Building Blocks. The following table describes the MedDRA queries available in your Vault:

MedDRA Query Type	Description
SMQ	SMQs are defined by MedDRA and can be imported into Vault Safety. The Active MedDRA version ZIP file is available on the MedDRA website. Each SMQ is a group of MedDRA Preferred Terms (PTs) for a medical condition or area of interest. To view the SMQs loaded in your Vault, go to the Business Admin > Objects > MedDRA Queries page. SMQs are labeled with (SMQ) in the MedDRA Query name.
CMQ	These queries are defined by your organization and configured by your Admin. CMQs can include Sub-Queries, which support creating a parent-child relationship between different CMQs.
Building Block	These queries are defined by your organization and configured by your Admin. MedDRA Query Building Blocks can combine SMQs, CMQs, and MedDRA Terms at any level of the hierarchy. They can be applied to multiple Datasheets and Watchlists that have the same list of expected and unexpected adverse events. When a MedDRA Query Building Block is updated, a single action allows you to apply the changes to all Datasheets and Watchlists that reference it. Building Blocks differ from CMQs in that they can reference other MedDRA Queries to create a single Query. This supports easier maintenance of Datasheets and Watchlists.

Learn more about running a MedDRA Query to search for Cases.

Prerequisites

• You must be a Business Admin to manage MedDRA Queries.
• Ensure that your Vault has the configuration required to support the following features, as needed:
  • Enable MedDRA Hierarchy Updates for CMQ and Vault Reporting
  • Enable Support for MedDRA Queries in Submission Rules
  • Enable Standardized and Custom MedDRA Queries
  • Enable MedDRA Query Building Blocks
  • Enable Datasheet Expectedness by Age and Sex

Import Standard MedDRA Queries

You can import standard MedDRA SMQs from a MedDRA Dictionary. Importing MedDRA SMQs is supported in English only. To load successfully, the MedDRA ZIP file version needs to match the current active version in your Vault.

1. Go to Business Admin > Objects > Dictionaries.
2. On the MedDRA Dictionary page, expand Attachments, and then select Upload.
3. Browse to the MedDRA ZIP file, select the file, and then select Open.
4. In the Details section, enter the license key for the MedDRA ZIP file.
5. Select Save, open the All Actions menu, and then select Import Standard MedDRA Queries.

Result

The system imports the SMQs and their associated terms from the MedDRA ZIP file.

Run a MedDRA Query

There are a number of pre-configured MedDRA SMQ/CMQ multi-pass reports in Vault Safety. Reports can contain a Root Query (only for a query with multiple subqueries) or Multiple Queries (only for searching across queries with no nested subqueries). Run these reports to search for Cases that match one or more SMQs/CMQs.

• SMQ/CMQ Search by Study Using Root Query Report: Search for Cases under a certain Study and with an Adverse Event that matches a given root query’s hierarchy.
• SMQ/CMQ Search by Study Across Multiple Queries Report: Search for Cases under a certain Study and with an Adverse Event that matches one or more given queries.
• SMQ/CMQ Search by Product Using Root Query Report: Search for Cases with a certain Product and an Adverse Event that matches a given root query’s hierarchy.
• SMQ/CMQ Search by Product Across Multiple Queries Report: Search for Cases with a certain Product and an Adverse Event that matches one or more given queries.

You can run these reports as-needed, schedule flash reports, or set up dashboards to monitor SMQs and CMQs. Manage Reports provides more information on using reports.

Configure MedDRA Queries

You can configure Custom MedDRA Queries (CMQs) and MedDRA Query Building Blocks to meet your organization’s adverse event monitoring needs. MedDRA Queries can be set up as non-hierarchical or hierarchical, as follows:

• Non-Hierarchical MedDRA Queries:
  • MedDRA Terms can be added at any level of the MedDRA hierarchy
  • MedDRA Query Building Blocks can be defined, including multiple SMQs and CMQs
• Hierarchical MedDRA Queries:
  • Sub-Queries can be added, which support creating a parent-child relationship between different CMQs

Add a Custom MedDRA Query

Complete the following steps to add a Custom MedDRA Query:

1. Go to Business Admin > Objects > MedDRA Queries.
2. Select Create.
3. On the Create MedDRA Query page, complete the following fields :
   • Organization: Select the organization that should have access to the query.
   • Name: Enter a name to label the query.
   • Description: Enter a description.
   • Hierarchical: To create a hierarchical CMQ that contains sub-queries, select Yes. To create a regular Medical Query that includes a combination of MedDRA Terms and Building Blocks, select No. If you create a hierarchical CMQ, you cannot add MedDRA terms to the parent CMQ. You can add the MedDRA terms to the sub-queries.
   • Submission Rule Scope: If using MedRA query parameters in a reporting rule, select one or both scopes for the MedDRA query:
     • Select Broad to query MedDRA terms where the Scope field is set to Broad.
     • Select Narrow to query MedDRA terms where the Scope field is set to Narrow. To learn more, see Reporting Rule Parameter Reference.
4. Select Save.

After You Finish

Add MedDRA Terms and MedDRA Query Building Blocks or Sub-Queries, as required.

Add a Sub-Query

You can add Sub-Queries to hierarchical MedDRA queries.

1. On a hierarchical MedDRA Query page, expand Sub-Queries, and then select Create.
2. Complete the Create MedDRA Query window, and then select Save.
3. Add additional Sub-Queries, as required.

Add a MedDRA Term

You can add MedDRA Terms to non-hierarchical MedDRA Queries and Sub-Queries.

1. On a non-hierarchical MedDRA Query or Sub-Query page, expand MedDRA Terms, and then select Create.
2. In the Create MedDRA Criteria window, complete the fields.
3. Add additional MedDRA Terms, as required.

MedDRA Criteria Fields

Field	Description
MedDRA Term	Enter the reported term in the text field to code the MedDRA term
Scope	Select whether the terms in the MedDRA Query record are Narrow, Broad, or both. Select Narrow or Broad to pull in values with the corresponding scope applied on the SMQ or CMQ term. Leave blank to pull in all values.

Add a MedDRA Query Building Block

You can add MedDRA Query Building Blocks to non-hierarchical MedDRA queries.

1. On a non-hierarchical MedDRA Query or Sub-Query page, expand MedDRA Query Building Blocks and then select Create. The Create MedDRA Query Building Block dialog appears.
2. In the MedDRA Query field, select an SMQ or CMQ and then select Save. You can also select Save + Create to immediately add another SMQ or CMQ to your Building Block.
3. Add additional Building Blocks, as required.

Apply MedDRA Queries to Datasheets and Watchlists

When you create a MedDRA Query record, you can apply it to Datasheets and Watchlists when managing individual Datasheets or Watchlists. You can also add MedDRA Queries to Datasheets and Watchlists from within MedDRA Query records.

Add MedDRA Queries to a Datasheet

Complete the following steps to add a MedDRA Query to a Datasheet:

1. Select the MedDRA Query record and expand the Datasheet MedDRA Queries section.
2. Select Create and then complete the fields.
3. Select Save.

Datasheet MedDRA Queries Fields

Field	Description
Datasheet	Select a Datasheet from the dropdown list.
Scope	Select whether the terms in the MedDRA Query record are Narrow, Broad, or both. Select Narrow or Broad to pull in values with the corresponding scope applied on the SMQ or CMQ term. Leave blank to pull in all values.
Expectedness	Select whether all the terms in the MedDRA Query are Expected or Unexpected.
Seriousness Exclusion	To define conditions for which the listed events are always Unexpected, select one or more seriousness criteria. When this field is defined, if Vault Safety evaluates Expectedness for a Case Adverse Event with any of the MedDRA Query record terms and one or more matching Seriousness values, the system populates Expectedness as "No" (Unexpected). If you populate this field, the system ignores the Unexpected Seriousness Criteria setting on the Datasheet for these terms.
Active Date Start	To specify when the terms were approved to be listed on the Datasheet, enter the date of approval. The date is inclusive. This field applies only to Clinical Trial Study Cases. This setting impacts expectedness evaluation in aggregate reports (DSUR, PBRER, and PSUR). Active Range for Expectedness in Aggregate Reports provides more information.
Active Date End	Optionally, to specify the last day when the terms were approved to be listed on the Datasheet, enter the end date. The date is inclusive. This field applies only to Clinical Trial Study Cases. The day after the Active Date End is the first day the terms are considered unlisted and unexpected. If you don't specify an end date, the term is considered actively approved and expected. This setting impacts expectedness evaluation in aggregate reports (DSUR, PBRER, and PSUR). Active Range for Expectedness in Aggregate Reports provides more information.
Description	Enter a description of the expected adverse events.
Age Range Start	Specify the earliest patient age for which a term is expected or unexpected. Enter a number and unit. The date is inclusive. Specifying an Age Range Start, but not an Age Range End, means the term applies to patients of a minimum age.
Age Range End	Specify the latest patient age for which a term is expected or unexpected. Enter a number and unit. The date is inclusive. Specifying an Age Range End, but not an Age Range Start, means the term applies to patients up to a maximum age.
Sex	Specify the sex for which a term is expected or unexpected. Select an option from the picklist or leave blank to include all sexes.

Add MedDRA Queries to a Watchlist

Complete the following steps to add a MedDRA Query to a Watchlist:

1. Select the MedDRA Query record and expand the Watchlist MedDRA Queries section.
2. Select Create and then complete the following fields:
   • Watchlist: Select a Watchlist from the dropdown list.
   • Scope: Select whether the terms in the MedDRA Query record are Narrow, Broad, or both. Select Narrow or Broad to pull in values with the corresponding scope applied on the SMQ or CMQ term. Leave blank to pull in all values.
3. Select Save.

Updating Datasheet and Watchlist Terms

Adding or changing a MedDRA Query record does not apply the terms to linked Datasheets and Watchlists automatically. When you are ready to make the changes available for use during Case processing, go to the All Actions menu and then select Update Datasheet and Watchlist Terms. The changes are then applied and available for use by Case Processors.

Copy a MedDRA Query

You can perform a deep copy of a MedDRA Query. This action creates a duplicate of the MedDRA Query and all its associated records, such as the MedDRA Criteria.

1. Go to Business Admin > Objects > MedDRA Queries.
2. Select the Actions beside a MedDRA query.
3. Select Copy MedDRA Query.

Result

The system copies the MedDRA query and its associated MedDRA criteria records. Both the copy and original query are linked to the respective MedDRA term.

The following diagram shows the MedDRA query deep copy process:

The Copy of MedDRA Query 3 does not have a Parent or Root query but it is the Parent/Root query for the Copy of MedDRA Query 4 and 5.