(Updated: Feb 2008)
How can I find out which SMQs are in production and which are in development ?
The MSSO provides an up-to-date listing of the status of SMQs in production or in development at http://www.meddramsso.com/MSSOWeb/SMQ/smqlist.pdf.
How does one use SMQs? Should they be downloaded into SAS ?
SAS is one of 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 the 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 helpdesk.
Is there a limit to the number of levels in an SMQ hierarchy? If so, do you expect that in the future there will be more levels of SMQs under one hierarchy “tree” ?
The current MedDRA file structure allows for up to five levels of SMQs. At the present time, the most levels used within a single SMQ topic is four. We do not foresee increasing the maximum above five in the future.
Is there any regulatory requirement to use
SMQs for safety assessment ?
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
(
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-9/pdf/vol9A_2007-04.pdf
) for safety signal detection including within the context of a
Periodic Safety Update Report (PSUR).
Is there any implementation guidance?
How do I know that I implemented the SMQ correctly
?
Both the SMQ Introductory Guide and ascii-conseq-document
(file-structure) provide guidance and information needed for
implementation. Due the nature of certain SMQs, customized
programming might be required.
My organization's system does not have the capability to
view SMQs. What tools are available for me to view the structure and
content of SMQs ?
The MSSO's free browser can be used to view the structure a
nd content of SMQs. From the View menu, select the option
“Show Standardised MedDRA Queries”. In addition,
the Production SMQ Spreadsheet (an Excel file) enables users
to view SMQs without a browser, and to copy and paste the data.
The SMQ Spreadsheet can be downloaded from:
http://www.meddramsso.com/MSSOWeb/SMQ/index.htm .
How do I submit a change request for SMQs
?
Submitting a change request for an SMQ is essentially the
same as submitting any other type of change request except you
would use the SMQ Change Request Form. For specifics, see the
Change Request Information document which can be found either
in the documentation with each MedDRA version release or on the
MSSO Web site at
http://meddramsso.com/MSSOWeb/mssosubs/coresubs/changereq_info.htm .
What process does MSSO use to maintain SMQs on a daily basis ?
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 of 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 team that created and tested it originally.
When will new SMQs be available ?
All SMQs go through a process of pre-production testing followed by actual
production,
which means they are approved for official use within the MedDRA terminology
(also available on the web site). Please review the SMQ section of the MSSO
Web site for up-to-date news and to access SMQs that are approved and posted.
These can be downloaded at http://www.meddramsso.com/Translations/translationDownloads.htm using your User ID and Password. To unzip the password-protected files, please use the Unzip password(s) for the MedDRA translation(s). Unzip passwords are sent to the designated point of contact for the subscription.
What has happened to "phase II" SMQs ?
“Phase II” refers to the time when pre-production Standardised MedDRA Queries (SMQs) were made available to MedDRA subscribers for initial database testing. Based on these phase II testing results, SMQs were then re-evaluated (and sometimes changed) by the CIOMS Working Group for SMQs. Following that step, SMQs were then authorized by the Management Board for production use. Once in production, the maintenance of SMQs is through the MSSO's change request process.
In July 2006, the MedDRA Management Board decided to end the phase II part of SMQ development. Once an SMQ has been tested by the Working Group, and after approval by the Board, it will be made available for full production use for subscribers through the MSSO.
Does this mean that I cannot comment upon the content and performance of an SMQ ?
Once an SMQ goes into production, the change request process goes into effect, i.e., subscribers will be able to request changes to an SMQ in much the same way that they can submit changes to MedDRA itself.
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 will be 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.
My organization is planning to implement SMQs for the next version of MedDRA. Do you have any advice to assure a smooth transition ?
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 ( http://www.meddramsso.com/MSSOWeb/Document_Library/DatRetPTC_R1.4.pdf ) recommends that organizations document their processes for data retrieval and presentation; this should also include the use of SMQs.
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