Customized MedDRA Queries

Customized MedDRA Queries (CMQ) enables users to easily upload and/or create their own custom lists of MedDRA Preferred Terms (PTs), and apply these lists in the Case Series Analysis tool (described in Advera Custom Analytics Framework section, below). To get started, click on the “TOOLS” icon at the top right side of any Evidex page to open the drop-down menu, then click on “Customized MedDRA Queries.”
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Next, if the user does not have any queries set up yet, click the “Create a new one” text to get started.
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Users must then type in a name and then click the blue “Save” button to save their CMQ:
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For uploading existing lists of PTs, supported file types include csv, xls and xlsx. The first column of an uploaded file should contain MedDRA PT codes, and the second should contain the Preferred Term name. A link to an example file has been included in the tool, circled in the image below. Clicking the blue “Choose File” button will allow users to select their file of terms from their computer. Clicking on “Upload” will upload the list to the Search Results box, at which point users can choose to click the green “Add below terms to CMQ” button. Users can also first choose to further customize their search by clicking the “Exclude” text to the right of any PT name they wish to exclude. 

Users can manually add Preferred Terms by searching for terms from several MedDRA Hierarchy levels (PT, HLT, HLGT, SOC, SMQ). The underlying Preferred Terms for a given term will be added to the Search Results box, at which time users can click the “Add below terms to CMQ” button to add the terms to the CMQ Definition table to the right. Users can also first choose to further customize their search by clicking the “Remove” text to the right of any PT name they wish to remove. 

Users will be allowed to upload and save terms that are invalid in the current Evidex MedDRA version. They will be given a warning that the CMQ contains Preferred Terms that are invalid, and those terms will not produce results when used in a search.

The CMQ tool includes a Product Specific Monitoring Event (PSME) flag. Users can import their PSME list to the CMQ builder to flag PSME (Product Specific Monitored Event) events from their ICSR database.

CMQs can be shared with others within a users’ organization, either with their entire organization (public), or specific users. All CMQ lists are set as “Private” by default, meaning they are not shared with any other users. 

Users can modify preferred terms of a CMQ that is shared with them, but they will not be able to rename or delete it. Users will be able to copy CMQs that have been shared with them using the Save As feature. After saving a copy of a shared CMQ list, users can then edit and share that new copy with other users within their organization.
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If a user wishes to assign a CMQ to a Signal, Inquiry or Request from within Evidex Signal Management, the CMQs sharing settings must be set to “Public (Shared with your organization)”. Once a CMQ is assigned to an ESM record, the CMQs sharing settings will no longer be able to be set to private or only shared with specific users. These CMQs will also not be able to be deleted. Users will be shown a summary of associated records when attempting to change sharing settings or deleting the CMQ. In order to change the sharing settings or delete the CMQ, users will first need to un-assign them from the associated records.

Clicking the “Show Edit History” button neat the top right-hand side of the Create/Edit CMQ form will bring users to the Audit Log for their organization’s use of CMQ. This enables users to view every edit made to any CMQ list within their organization. Users can also view any record changes related to Case Profiles, File Attachments, or Evidex Signal Management items.

Within the “Search” box, clicking on “Change Type” or “Changed By” enables users to make selections from the drop-down menu to edit their search criteria for the Audit Log. Clicking on the down arrow to the right of the “Start Date” or “End Date” boxes opens a calendar for users to select date ranges. Clicking on a date will enter it into the box. Clicking the “<” or “>” arrows within the calendar will move the calendar back or forward one month. Clicking on the circle icon between the two arrows will choose the current day’s date. Clicking the blue “Search” button will run the Audit Log with the new criteria entered. 

The “Details” table displays all records related to the criteria entered into the Search box above. Clicking on the down arrow next to any column name opens a drop-down menu, which allows users to sort by the given column in ascending or descending order, hide the column from view, or pin the column to the or the right-hand side of the data table. Users can also make selections from or search within the quick-filter headers for each data column to quickly further sort the data table. Clicking on the menu icon in the upper right corner of the data table opens a drop-down menu which allows users to select which columns are visible, and export data to Excel or as a PDF.