Recode a MedDRA or MedDRA J dictionary

About MedDRA Recode

MedDRA recoding is the process of re-coding the medical terms used in the existing cases that were already coded with a prior version of MedDRA to a new version of MedDRA. This new MedDRA version must be configured in the System Configuration.

This is necessary when a new MedDRA version is released, and it ensures that medical product safety data remains accurate and consistent over time by updating terms that may have changed or been organized differently in the new dictionary.

To access the MedDRA Recode menu, the user must login through the default enterprise and must belong to a user group that has the MedDRA Recode option enabled under Access Management, in the Groups window, in the Menu section.

The MedDRA Recode pages are asynchronous, once the recoding is initiated, you can move to other windows.

Recode the MedDRA terms

To recode the MedDRA terms, make sure an enterprise must have at least one case. An enterprise is eligible for selection only if it has associated cases.

  1. From Argus Console, go to Tools, click Dictionary Management and select MedDRA Recode.
  2. Select the enterprise. Multiple enteprises can be selected using the CTRL + click option.

    Note:

    To view logs for multiple enterprises, see About the log file generation
  3. In the Select the Source MedDRA Version that was used for coding field, select the version that is to be recoded.
  4. Select:
    • Update to recode the Argus events encoded in the selected MedDRA version to the MedDRA version selected in the system configuration in the common profile switch.

      Note:

      System downtime is required to recode MedDRA in the Update mode. For more information, see Configuring System Maintenance.
    • View Only to generate logs that can be used to evaluate the cases and fields that are affected by the recode. When this option is selected, the Select the target MedDRA version that will be used to recode in View Only Mode is displayed to allow you to select the target version for which you want to see the logs.
  5. Select to code either the current or non-current terms in the Coding Data Update/View Options (Currency determined at LLT level only) section.
  6. Click Execute.
MedDRA Recode

See also: