MedDRA SMQ FAQs

The MSSO provides an up-to-date listing of the status of SMQs in production or in development. Please visit the Standardised MedDRA Queries page and click on the Status of SMQs in Production and Development link.

SAS is one of the tools that could be used for SMQs in data analysis. In addition to downloading the SMQ tables into SAS, you will probably need to have some level of SQL coding, or programming support, to take full advantage of SMQ search options, such as narrow and broad search scopes, algorithms, and the SMQ hierarchy.

Be aware that different MedDRA analytical tools could implement SMQs in different ways. If you need further assistance for your specific organization and tools, please feel free to contact the MSSO Help Desk. Please visit the MedDRA Software Tools section for available software tools.

The current MedDRA file structure allows for up to five levels of SMQs. As of the current MedDRA version, only one SMQ - SMQ Hepatic disorders - has the maximum of five hierarchical levels. We do not foresee increasing the maximum above five in the future.

The MSSO is unaware of any regulation in the ICH regions that requires the use of SMQs. In the EU, SMQs have been recommended in the Pharmacovigilance Guideline Volume 9A for safety signal detection including within the context of a Periodic Safety Update Report (PSUR).

Both the SMQ Introductory Guide and ascii-conseq-document (file-structure) provide guidance and information needed for implementation. Because of the nature of certain SMQs, customized programming might be required.

There are two browsers available to subscribers to view the structure and content of SMQs. The browsers are available to all MedDRA subscribers as part of their MedDRA subscription.

The MSSO's MedDRA Desktop Browser can be used to view the structure and content of SMQs. From the View menu, select the option Show Standardised MedDRA Queries.

The MedDRA Web-Based Browser also shows the SMQs. Click on the SMQ tab on the upper left corner of the Web-Based Browser window to view and search SMQs.

In addition, the Production SMQ Spreadsheet (an Excel file), which can be found on the SMQ page, enables users to view SMQs without a browser, and to copy and paste the data.

MedDRA users may submit changes using WebCR. Alternatively, users may use the SMQ Change Request Form, located on the Change Request Information Web page.

SMQ change requests are handled in much the same way as regular MedDRA requests although they do not have the same timelines for responding to user requests as for MedDRA changes. Beyond that, the actual process is more or less the same. 

For subscriber-generated requests, MSSO may ask the requestor to provide justification in the form of testing results so we can be sure that the requested change will be beneficial and not detrimental to the SMQ. 

Currently, most of the changes to SMQs between versions are due to changes to MedDRA itself, i.e., they are not subscriber-generated. The MSSO reviews all of the terms added in the new version and checks them against the inclusion and exclusion criteria for each SMQ to determine if terms should be added or not. If we are not certain, we may consult with the CIOMS Working Group teams who developed the SMQ for additional guidance. We also review the existing terms in the SMQ to see if any have been demoted, moved, etc., and make changes accordingly.

Finally, after 18 – 24 months in production, all SMQ change requests for a given SMQ are reviewed by the CIOMS Working Group.

Once an SMQ goes into production, the change request process goes into effect, i.e., subscribers are able to request changes to an SMQ using WebCR or the SMQ Change Request Form, located on the Change Request Information Web page.

Additionally, the MSSO would like to have your feedback on SMQ content and file structure.

After an SMQ has been in production for 18 – 24 months, there is a review of all the changes made or proposed for the SMQ by members of the CIOMS Working Group. This will provide a second level of oversight of subscriber and MSSO-generated changes to assure the continued quality of SMQs.

Training – This is an important aspect of an SMQ implementation.  If a user does not understand the intent of SMQs and how they have been built, they could be misused or the retrieved data could be misinterpreted.  Both IT staff and medical staff (safety assessors, medical writers - anyone who queries safety data and interprets it) need to get SMQ training.

Documentation – Both the SMQ Introductory Guide and all of the other documentation related to file structure, etc. that come with your organization's MedDRA subscription should be thoroughly reviewed.  Besides having information about the file structure (which is important for implementing SMQs in your system), other documents, such as the SMQ Introductory Guide, have detailed information about each individual SMQ, the way it was constructed, and what caveats the user must know when interpreting the retrieved information.

Processes - The Data Retrieval and Presentation: Points to Consider document (.pdf), which can be found on the Points to Consider page, recommends that organizations document their processes for data retrieval and presentation; this should also include the use of SMQs.