Analyzing the Impact of Changed Terms in MedDRA

After upgrading the MedDRA classifications, you can run an impact analysis report to determine if any of the changes in the new version affect indications defined for your products.

Required access role: Regulatory Administrator

Before you begin:
  1. From the MedDRA Version list on the page toolbar, make sure the most recent (highest) version number is selected.
  2. From the page Actions menu or toolbar, select Impact Analysis.

    The app generates the report. The report includes these columns:

    Column NameDescription
    Old MedDRA VersionThe version of the MedDRA dictionary in which the previous classification was included.
    Old ClassificationThe classification hierarchy of the term associated with the submission master record, from a previous version of the MedDRA dictionary.
    New ClassificationThe classification hierarchy of the term associated with the submission master record, from the newest version of the MedDRA dictionary, showing the changes to the term in red.
    New MedDRA VersionThe version of the MedDRA dictionary in which the new classification is included.
    Impacted DataA comma-separated list of submission master records that include this classification as an indication. You can click the name to open that submission master record.

  3. If you want to update the indication related to the shown submission master record to use the new classification, click Update Classification. You must be a Regulatory Administrator to perform this action.
    The app updates the indication for all shown submission master records to use the new classification terms.
  4. If you want to remove classifications that no longer exist in the new version of the dictionary from the indications related to the shown submission master records, click Remove Classification. You must be a Regulatory Lead to perform this action.