Use MedDRA Queries

Use standardized MedDRA queries (SMQs) and custom queries (CMQs) to find patterns in previously processed Cases and discover new adverse events.

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About MedDRA Queries

MedDRA queries are a useful tool for signal detection and analysis of similar adverse events. Vault Safety supports both Standard MedDRA Queries (SMQs) and Custom MedDRA Queries (CMQs).

MedDRA queries are added to your vault by importing a MedDRA dictionary (for SMQs) or by configuring custom queries (for CMQs). Each SMQ is a group of MedDRA Preferred Terms (PTs) for a medical condition or area of interest. To run a MedDRA query, you can use Vault’s robust reporting features to search for cases.

When you import a MedDRA dictionary, Vault Safety imports all Standard MedDRA Queries (SMQs) included in that MedDRA version. Vault Safety keeps track of which MedDRA versions apply to each SMQ.

To view the standard queries loaded in your vault, go to the Business Admin > MedDRA Queries page. SMQs are labeled with (SMQ) in the MedDRA Query name.

Prerequisites

Import Standard MedDRA Queries

You can import standard MedDRA SMQs from a MedDRA Dictionary.

  1. Go to Business Admin > 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.

    Note To load successfully, the MedDRA .zip file version needs to match the current active version in your vault.

  5. Select Save, open the All Actions (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 or Multiple Queries. 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 Custom MedDRA Queries

You can configure Custom MedDRA Queries (CMQs) to meet your organization’s adverse event monitoring needs.

Add a Custom MedDRA Query

  1. Go to Business Admin > MedDRA Queries.
  2. Select Create.
  3. On the Create MedDRA Query page, complete the following fields:
    Field Description
    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 CMQ, 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 Sub-Queries and MedDRA Terms, 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 an LLT 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 following fields:
    Field Description
    MedDRA Term Select Binoculars-Icon, and then select the MedDRA term.
    Code MedDRA Terms provides more information on using the MedDRA browser.
    Scope Select whether the term is Narrow or Broad.
  3. Add additional MedDRA Terms, as required.

Add a Higher-Level MedDRA Term

You can add higher-level terms (PT, HLT, HLGT, and SOC) to a CMQ using Vault Loader to load the MedDRA query criteria.

Vault Loader: Create, Update & Delete Object Records provides more information on how to use this tool.

Copy a MedDRA Query

You can perform a deep copy of a CMQ (Custom MedDRA Query) or SMQ (Standard MedDRA Query). This action creates a duplicate of the MedDRA query and all its associated records, such as the MedDRA Criteria. The MedDRA query copy and its records are editable.

  1. Go to Business Admin > MedDRA Queries.
  2. Select alt-text 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:

deep-copy-medDRA-query
Deep Copy of MedDRA Query

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.


Manage the MedDRA Dictionary
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