The FDA Medical Query (FMQ) file is an Excel file available for download (link below video) that is required by three reports in JMP Clinical: the Algorithmic FDA Medical Query Risk Report, the Medical Query Risk Report, and the Drug-Induced Liver Injury findings report. You must download this file and place it in the appropriate location before you can add these reports to a study review. This video demonstrates downloading the file and determining the specific path that JMP Clinical will use for it.
Link to download the Excel file: https://www.regulations.gov/document/FDA-2022-N-1961-0001
Transcript:
This video illustrates the steps you need to take before you can run the Algorithmic FDA Medical Query Risk Report, or aFMQ Risk Report, or the Medical Query Risk Report, for the first time. To run these reports, JMP Clinical requires an Excel file containing the FDA Medical Queries, or FMQs. These reports are designed to take advantage of both the FMQ mapping of preferred, or dictionary-derived terms, for adverse events, and in the case of the aFMQ Risk Report, the mapping of the algorithmic components associated with these queries.
JMP Clinical creates a folder for the FMQ file during installation, but you have to download the Excel file and save it in that folder so JMP Clinical can access it when you add either of these reports to a study review. The link to the website containing the file is on the page below this video.
You can download the file from the attachments section of the web page.
Back in the JMP Clinical Main Window, you’ll need to click on the Settings tab, and click Manage Configurations to identify the path that your copy of the software will use for the FMQ file. In the example here, JMP Clinical will look for the FMQ folder in Documents in my OneDrive folder. Once you’ve determined the path, you can close the Manage Configurations window.
After I navigate to the location of the FMQ folder and open it, there’s a subfolder for the current FMQ version, and I want to put the downloaded file into this subfolder.
Let’s take a quick look at the contents of the Excel file. The first sheet provides a Table of Contents with a list of FMQs. <scroll> Hyperglycemia is one of the FMQs in the Nicardipine data set that’s installed with JMP Clinical and used in these tutorial videos. The medical queries in the Table of Contents are hyperlinked to their respective worksheets, so I can click on Hyperglycemia to navigate to it. The worksheet lists the preferred terms associated with this FMQ, and because it’s an event with an algorithmic component, there’s a comment explaining the criteria. JMP Clinical uses these criteria to determine counts, percent occurrence, and risk in the aFMQ Risk Report.
If you open the Excel file, you’ll need to close it before trying to run the reports.
So you’ve seen how to download the Excel file and determine the appropriate location for it. This action only needs to be performed once, and now you can add the aFMQ or Medical Query Risk Reports to any study review.
