Medical Query Type

This widget enables you to specify whether you are using the FDA Office of New Drugs Custom Medical Queries (OCMQs) 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 Office of New Drugs Custom 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.

If SMQs are selected, then the AE dataset from the study will be joined with the MedDRA ASCII files to map each AE to the associated medical queries.

FDA Office of New Drugs Custom Medical Query terms (OCMQs) are similar to SMQs. They are being promulgated by the FDA to further consolidate and standardize descriptions of medical conditions. Excel files containing OCMQs can be downloaded from here. Downloaded files should be saved to $DOCUMENTS\OCMQ. When there are multiple versions of the OCMQs in the specified folder, you can use the Version of Office of New Drugs Custom Medical Query Files/Version of Standardized Medical Query Files widget on the Set Study Preferences window to specify which version of the OCMQs to use.

If the OCMQs are selected, then the AE dataset from the study will be joined with the OCMQ Excel file to map each AE to the associated medical queries.

Click below to view a video summary of OCMQ Medical Query files.

Excel files containing OCMQs can be downloaded from https://www.fda.gov/drugs/development-resources/office-new-drugs-custom-medical-queries-ocmqs.

You may save more than one version of the SMQ and/or OCMQ 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 OCMQ files to a different location, you must specify the alternate location on Manage Configurations .

Note: If multiple language-specific SMQ files exist in the folder specified in Manage Configurations, you must point JMP Clinical to the file matching the language-specific version of JMP Clinical you are using.