Summary

The Medical Coding Dictionary Upgrade Utility is used to reduce the complexity and effort of mid-study medical dictionary upgrades while increasing the visibility of changes associated with the upgrade. This page describes the steps necessary to complete the upgrade process.

Table of Contents

Trial Design

Before the upgrade can occur, the ‘upgradeDictionary’ permission must be added to the Roles worksheet and the trial must be configured to use the new dictionary version.

Roles

  1. Actions: Enter ‘coding – upgrade dictionary.’
  2. Actions Required: Enter ‘upgradeDictionary.’
  3. Screens Required: Enter ‘upgradeDictionary.’


Codes

On the Codes worksheet, update the Reference – Key Name value and any other values that must be changed. For the same dictionary, you should not have two versions configured for different questions when upgrade utility is used. For example if MedDRA 18.0 is on Medical History and Adverse Events, and is updated to 18.1 for Medical History, the upgrade utility will not upgrade just the Medical History. 18.0 cannot be assigned to any question to upgrade from 18.0 to 18.1.

Note: When choosing a new dictionary, the old and new dictionary must have the same format. For example, the B2 format of the WHO2016SEP cannot be upgraded to the C format of any WHO dictionary. The B2 format can not be upgraded to the B3 format, and the C format cannot be upgraded to the C3 format. You also cannot upgrade from the C format to the B format. You can only go from a B2 version to another B2 version or from a C version to another C version or a B3 version to another B3 version or a C3 version to another C3 version. Once the Medical Dictionary is updated, it is not advisable to switch between dictionary formats.
Warning: Do not change dictionary formats between the old and new versions, the two version are incompatible.


System

Once the trial has been configured for dictionary upgrades, the utility can be used.

Initiate Dictionary Upgrade

  1. On the Study Homepage, hover the mouse over the ‘Actions’ tab and select ‘Upgrade Dictionary.'


  2. On the Upgrade Dictionary screen, use the dropdown list to select the dictionary that needs to be upgraded.
    The options available in the list should represent all the dictionaries that have been used to code medical terms in the study but are no longer included in the trial configuration.


  3. Click the ‘Continue’ button to continue with the upgrade or click the ‘Back’ button to cancel the action and return to the Study Homepage.
  4. On the next screen, use the dropdown list to select the dictionary that you will be upgrading to.
    The options available in the list should represent all the dictionaries currently configured for the trial whose format matches the dictionary being upgraded.


  5. Click the ‘Continue button to continue with the upgrade or click the ‘Back’ button to return to the previous screen.

Review Synonym Upgrades

After selecting the new dictionary, you can review and approve the Synonym Upgrade Preview.

  1. Review the Synonym Upgrade Preview screen.
    This screen identifies the total number of synonyms currently configured in the study that will be modified or upgraded. The screen also displays the synonyms that will be lost because there is no direct match within the new dictionary.

Terms on locked forms will not be updated to the new dictionary. The best Practice is to unlock the forms and then run the utility. Terms frozen but not locked will be updated.



  1. If you want to retain a log of the previous Synonym Upgrade, click the ‘Download log file’ link.

This log file will overwritten when you click the ‘Continue’ button in the next step.


  1. Click the ‘Continue’ button to upgrade synonyms or click the ‘Back’ button to return to the previous screen.
    The following screen will display the results of the Synonym Upgrade.
  2. Click the ‘Continue’ button to continue with the upgrade process.

Review Coding Upgrades

After completing the Synonym Upgrades, you can review and approve the Coding Upgrade Preview.

  1. Review the Coding Upgrades Preview screen.
    The screen identifies the total number of codes that will be modified. This total count is then broken down into the number of codes that will upgraded and the number of codes that will be recoded. Recoding involves auto-coding the adverse event term or medication recorded. The screen also identifies the number of codes that cannot be upgraded and provides a link to download detailed information about these codes.
  2. If you want to review a detailed log of the codes that cannot be modified, click the ‘Click here to download’ link.
  3. Click the ‘Continue’ button to continue with the process and upgrade the codes or click the ‘Cancel’ button to stop the process and return to the Study Homepage.

    The following screen will display the results of the upgrade
  4. On the results screen, click the ‘Download log file’ link to download a detailed log of all the coding upgrade actions taken throughout the upgrade process.
  5. Click the ‘Upgrade Completed’ button to return to the Study Homepage.

Need more help?

Please visit the Fountayn Contact Information page.