Upgrading TMS Dictionaries

The general steps involved in upgrading a dictionary in TMS include:

  1. Load the new dictionary version into temporary tables and then into the predictionary tables. Use the instructions in Defining and Loading Dictionaries.
  2. Run the Dictionary Impacts Report showing current VTAs and omissions that will be impacted by updated, added, or deleted dictionary terms in the new dictionary version. See Reports and Batch Jobs for more information.
  3. Run the Autoprocess VTAs job to automatically load the affected verbatim terms into the predict tables if they are not already there and perform the required classifications, reclassifications, and declassifications.

    Note:

    VTA is not coded if the term exists as an unanswerable negative list action assignment.

  4. Manipulate the data manually if necessary; see Maintaining Predictionary Terms and Relationships.
  5. Run the specialized dictionary upgrade reports. Return to the Maintain Predictionary VTAs/VTIs window to fix problems, rerun the reports, and fix additional problems as necessary.

    The dictionary upgrade reports include:

    • Predict VTAs/VTIs Report. This report displays VTAs in the Activation Group you specify in the following groups: classifications, reclassifications, and declassifications. The same data is displayed in the first three tabs of the Maintain Predictionary VTAs/VTIs window. If the Activation Group includes terms and relations in more than one dictionary, you can choose to see them all or specify a single base dictionary.

    • Site Impacts Report. This report lists the external system databases from which affected verbatim term occurrences came, with their associated X Area. For Oracle Clinical, this is the study in which the verbatim term occurrence was collected.

    • Omission Impacts Report. This report lists omissions that will be resolved (by the addition of a dictionary term that is a direct match) as well as new omissions that will be created (by the deletion of a dictionary term to which verbatim terms are classified) by Activation and Synchronization. This report also shows the actions applied to the current omissions, if any.

    • Cross-Dictionary Impacts Report. This report lists terms in other dictionaries that have links defined to affected terms in the new dictionary version.

  6. Activate the Activation Group in Check or Transfer mode. See Activating Loaded Terms
  7. Run the Preliminary Repository Report to show errors resulting from the Activation. See Preliminary Repository Report for more information.
  8. If necessary, make changes manually using the instructions in Maintaining Predictionary Terms and Relationships and rerun Activation. Repeat this process as necessary.
  9. Run a new Site Impacts Report to determine which X Areas on which external system sites are impacted. See Site Impacts Report for more information.
  10. Run the data exchange job between TMS and the external system for the affected X Areas. If the external system is Oracle Clinical, run Batch Validation for the affected studies on the affected sites.