Updating the MedDRA Dictionary

MedDRA - the Medical Dictionary for Regulatory Activities - is a classification of medical terminology for adverse event information. This data is coded to provide a standard set of MedDRA terms, so that health professionals can easily share and analyze data related to the safety of medical products. Users should obtain a copy of the MedDRA dictionary from the appropriate source, as this does not come standard with the ExtraView solution. Please note that the dictionary that is obtained directly from MedDRA is not the correct format to load directly into ExtraView, and therefore will need to be altered. ExtraView support will either provide you with a copy in the correct format, or they will assist you in converting your downloaded version into a more suitable format that is compatible with ExtraView. Having the file in the correct format is also a prerequisite for uploading the latest version of the dictionary.

The MedDRA solution is deliberately configured so that no user can modify the MedDRA terms that have been uploaded. The administrator should not provide permission to any end user to change the data loaded into the template.

Uploading a new MedDRA version

It is important to understand that importing a new version of the data does not remove any of the old version of the data. All issues that point to MedDRA dictionary will retain their original link to the specific version of the dictionary that was used when recording the adverse event.

  1. To upload a new version of the MedDRA dictionary please sign on as an administrator.
  2. Click on the Admin tab in the main menu bar
  3. Select Import/Export
  4. Select File Import - Issue data

    File Import
  5. You should see a template with the title Import MedDRA Hierarchy Data. Edit this template.

    File Import Template Selection
  6. Do not change any of the field mappings or settings
  7. In the field Upload a different file, please Browse for the new version of the dictionary that you wish to upload.

    Browse for a new version
  8. Click Save mappings / Upload new file at the top of the screen in the menu bar. Do not change any of the field mappings.

    Save mappings / Upload new file
  9. Then select Validate import file from the menu bar, and click OK for the notification.

    Validate import file
  10. You will see a summary of imported records similar to this:

    Summary

    If there are any errors, do not proceed, please contact ExtraView support services

  11. Click Return
  12. Next select Perform Import from the menu bar, and click OK

    Perform Import
  13. You will see a progress screen similar to the following

    Import Progress
    And when the file import is completed, something similar to this:

    Import Successful
  14. Please note that the number of rows entered or created should be one less than the number of rows in the file, as the first row in the csv file is considered a header. For accuracy confirmation, please take note of this number
  15. Click Return and check that the new data was loaded correctly by running a report

Running a MedDRA Report to check for a successful import

  1. From the main menu bar, choose the Report option.
  2. Select MedDRA Reports
  3. Run the MedDRA Summary Report
  4. Enter in the new MedDRA version for the filter critera.

    Enter Version filter
  5. Run the Report
  6. Check that the report returns some issues. To ensure accuracy, go to the bottom of the report and look at the Total row. This number should be the same as the one you noted a few steps previously when you uploaded the file.

Important User Information

It is imperative that you inform your users that a new version of the MedDRA Dictionary is available. The next time that they add a new incident with a new adverse event all users will need to change the version on the MedDRA term search so that they are looking at the most current set of terms. ExtraView remembers the new entry for subsequent searches, so users will only have to perform this task once, and ExtraView will remember the newest value for the version.


Chance last value of version