Medical Query Type
This widget enables you to specify whether you are using the FDA medical queries (FMQs) or standard medical queries (SMQs).
The Medical Dictionary for Regulatory Activities (MedDRA), maintains a list of the preferred Standard Medical Query terms (SMQs) that are used to support signal detection and monitoring. They are used routinely by many companies and international regulatory agencies. SMQs may be broad or narrow and are used to codify descriptions of adverse events for analysis. SMQ files are downloaded from MedDRA. A subscription is required. Downloaded files should be saved to $DOCUMENTS\SMQ. When there are multiple versions of the SMQs in the specified folder, you can use the Version of FDA Medical Query Files/Version of Standardized Medical Query Files widget on the Set Study Preferences window to specify which version of the SMQs to use.
FDA Medical Query terms (FMQs) are similar to SMQs. They are being promulgated by the FDA to further consolidate and standardize descriptions of medical conditions. Excel files containing FMQs can be downloaded from here. Downloaded files should be saved to $DOCUMENTS\FMQ. When there are multiple versions of the FMQs in the specified folder, you can use the Version of FDA Medical Query Files/Version of Standardized Medical Query Files widget on the Set Study Preferences window to specify which version of the FMQs to use.
Click below to view a video summary of FMQ Medical Query files.
Excel files containing FMQs can be downloaded from https://downloads.regulations.gov/FDA-2022-N-1961-0001/attachment_1.xlsm.
You may save more than one version of the SMQ and/or FMQ files. By default, JMP Clinical will automatically use the latest version unless you specify an earlier version..
Note: If you save either the SMQ or FMQ files to a different location, you must specify the alternate location on Manage Configurations .