1. User's Guide
  2. Setting Up and Administering TMS
  3. Upgrading to a New Dictionary Version
  4. Running Dictionary Upgrade Reports

Running Dictionary Upgrade Reports

TMS includes the following dictionary upgrade reports:

Parent topic: Upgrading to a New Dictionary Version

Dictionary Impacts Report

The Dictionary Impacts Report displays all the global VTAs, VTIs, and current omissions that will be affected by a base dictionary upgrade. You can run the Dictionary Impacts Report before or after the Autoprocess VTAs/VTIs job. You can run this report only on a base dictionary and in the global domain.

The report includes the following sections:

  • The Assigned Dictionary Term Will Be Deleted for the Following VTAs/VTIs If the new dictionary version deletes dictionary terms to which VTAs or VTIs are currently classified, you must reclassify the affected terms.

    Each row of the report displays one verbatim term that will be declassified, with the following information:

    • The affected dictionary

    • The affected domain

    • The verbatim term

    • The classification type: VTA or VTI

    • The VTA or VTI ID

    • The dictionary term and its ID

  • The Assigned Dictionary Term Will Be Updated for the Following VTAs/VTIs If the new dictionary version modifies some dictionary terms to which VTAs or VTIs are currently classified, you may want to reclassify the affected terms.

    Each row of the report displays one affected verbatim term, with the following information:

    • The affected dictionary

    • The affected domain

    • The verbatim term

    • The classification type: VTA or VTI

    • The VTA or VTI ID

    • The approval status of the existing VTA or VTI

    • The dictionary term and its ID

  • There Will Be a Direct Match for the Following VTAs If the new dictionary version includes new terms that are a direct match to VTAs that are currently to nonmatching dictionary terms, you may want to reclassify the verbatim terms to the new, matching dictionary terms. (You can do this automatically by running the Autoprocess VTAs/VTIs job with Reclassify Direct Matches set to Yes.)

    Note:

    If any dictionary/domain combination allows classification to nonapproved dictionary terms, this report includes verbatim terms in that dictionary domain that are a direct match to both approved and nonapproved dictionary terms. This could be the case in MedDRA-J, for example. See Assigning a Dictionary to a Domain for more information.

    Each row of the report displays one affected verbatim term, with the following information:

    • The affected dictionary

    • The affected domain

    • The verbatim term

    • The approval status of the existing VTA

    • The new dictionary term that is a direct match

  • There Will Be a Direct Match for the Following VTIs If the new dictionary version includes new terms that are a direct match to VTIs that are currently to nonmatching dictionary terms, you may want to reclassify the verbatim terms to the new, matching dictionary terms. (You can do this automatically by running the Autoprocess VTAs/VTIs job with Reclassify Direct Matches set to Yes.)

    If the new, matching dictionary term is unique, it may be a candidate for a VTA. If it is not unique, any auxiliary information is not processed. You must manually classify the VTI if you are using auxiliary information.

    Each row of the report displays one affected verbatim term, with the following information:

    • The affected dictionary

    • The affected domain

    • The verbatim term

    • The approval status of the existing VTI

    • The new dictionary term that is a direct match, and its ID

    • Whether or not the dictionary term is unique in its level

To generate a Dictionary Impacts Report:

  1. Select Dictionary Upgrade in the navigator window.
  2. Select Dictionary Impacts Report.
  3. Fill in the general report specifications. See Setting Parameters
  4. Enter a value for each Job Specific parameter:

    • Activation Group: Select the Activation Group that contains the new version of the dictionary.

    • Base Dictionary: Select the base dictionary being upgraded. If unselected, all base dictionaries in the Activation Group are processed.

    • Template: Select the report template. If your company has created a custom template, it appears in the list of values. The Oracle Template is the default template.

  5. Submit the job. See Running a Job

Parent topic: Running Dictionary Upgrade Reports

Predict VTA/VTI Report

The Predict VTA/VTI Report shows the current state of VTAs and VTIs in the predictionary tables for a particular Activation Group and dictionary specified at runtime and indicated in the report header.

Accordingly, the report groups the VTAs and VTIs into the following sections:

  • Classifications: Displays verbatim terms in the predictionary classification table.

  • Reclassifications: Displays the terms in the predictionary reclassifications table. These reclassifications may have been done by the Autoprocess VTAs/VTIs job or manually.

  • Declassifications: Displays terms in the predictionary declassifications table. These declassifications may have been done manually or by the Autoprocess VTAs/VTIs job.

The following columns are displayed in the above report sections:

  • Dictionary

  • Domain

  • Verbatim Term

  • Type: VTA or VTI

  • VTA or VTI ID

  • Dictionary Term and its ID (This is blank for declassifications)

  • Old Dictionary Term and its ID (only for Reclassifications)

Note:

Only Superusers can run this report

To generate a Predict VTA/VTI Report:

  1. Select the Predict VTA/VTI Report from the Dictionary Upgrade menu.
  2. Fill in the general report specifications. See Setting Parameters
  3. Enter a value for Job Specific parameters:

    • Activation Group: Select the Activation Group that contains the new version of the dictionary.

    • Base Dictionary: Select the appropriate base dictionary to define the scope of the report. If not selected, all base dictionaries within the selected Activation Group are processed by default.

    • Template: Select the template for the report. If your company has created a custom template, it appears in the list of values. The Oracle Template is the default.

  4. Submit the job. See Running a Job

Parent topic: Running Dictionary Upgrade Reports

Site Impacts Report

The Site Impacts Report displays the X Areas affected by a dictionary upgrade on a particular site.

In Oracle Clinical, an X Area is a study. If you select Oracle Clinical as the external system, the report displays actual study names. If you are using a different external systems, the report displays either the X Area ID or a recognizable name you specify using a function. See Defining External System Information in TMS.

Run the Site Impacts Report after the Autoprocess VTA job.

The Site Impacts Report displays the following:

  • The external system in use

  • The list of X Areas affected by the upgrade

  • The corresponding X Area names

  • The external system instance

    Note:

    This report includes sites affected by an upgrade because at least one dictionary/domain combination allows classification to nonapproved dictionary terms, and the upgrade includes nonapproved dictionary terms that are a direct match to verbatim terms currently to a different dictionary term. This could be the case in MedDRA-J, for example. See Assigning a Dictionary to a Domain for more information.

To generate a Site Impacts Report:

  1. Select Dictionary Upgrade in the navigator window.
  2. Select Site Impacts Report.
  3. Fill in the general report specifications. See Setting Parameters
  4. Enter a value for Job Specific parameters:

    • Activation Group: Select the Activation Group that contains the new version of the dictionary.

    • External system: Select an external system.

    • Remote Instance: Select a site. The default instance is the current site.

    • Template: Select the report template. If your company has created a custom template, it appears in the list of values. The Oracle Template is the default template.

  5. Submit the job. See Running a Job

Parent topic: Running Dictionary Upgrade Reports

Omission Impacts Report

A dictionary upgrade resolves omissions if a new dictionary term is added that is a direct match, and creates new omissions if the dictionary term to which a VTA or VTI is mapped is deleted.

For both omissions that will be resolved and omissions that will be created, the Omission Impacts Report displays the following:

  • Domain

  • Dictionary

  • External system instance

  • External system name

  • X Area

  • X Area name (if available)

  • Term

  • Number of records affected

    Note:

    For omissions that will be resolved, this report includes omissions that are a direct match to a nonapproved dictionary term, if their dictionary domain allows classification to nonapproved dictionary terms. This could be the case in MedDRA-J, for example. See Assigning a Dictionary to a Domain for more information.

To generate an Omission Impacts Report, do the following:

  1. Select the Omissions Impacts Report from the Dictionary Upgrade menu.
  2. Fill in the general report specifications. See Setting Parameters
  3. Enter a value for each job-specific parameter:

    • Activation Group: Select the Activation Group that contains the new version of the dictionary.

    • External System: Omissions may be created from any of the external systems linked with TMS. Select the required system from the list provided here.

    • Remote Instance: You can select a remote database if there is one, from the drop-down list. The report runs on the current instance by default.

    • Base Dictionary: Select the appropriate base dictionary to define the scope of the report. All base dictionaries within the selected Activation Group are processed by default.

    • Template: Select the template for the report. If your company has created a custom template, it appears in the list of values. The Oracle Template is the default.

  4. Submit the job. See Running a Job

Parent topic: Running Dictionary Upgrade Reports

Cross Dictionary Impacts Report

If you have mapped terms across dictionaries using named relationships (NRLs), these mappings will be affected if either of the related terms is deleted. The Cross Dictionary Impacts Report lists all affected relations.

Run the Cross Dictionary Impacts Report before or after the autoprocess VTA job.

For each affected named relation, the Cross Dictionary Impacts Report displays the following:

  • Domain

  • The dictionary and dictionary level on the From side of the relation

  • The dictionary and dictionary level on the To side of the relation

  • The term on the From side of the relation

  • The named relationship definition used

  • The term on the To side of the relation

  • The DML

  • The error message (gives the ID of the missing term)

To generate a Cross Dictionary Impacts Report:

  1. Select Dictionary Upgrade in the navigator window.
  2. Select Cross Dictionary Impacts.
  3. Fill in the general report specifications. See Setting Parameters
  4. Enter a value for Job Specific parameters:

    • Activation Group: Select the Activation Group that contains the new version of the dictionary.

    • Template: Select the report template. If your company has created a custom template, it appears in the list of values. The Oracle Template is the default template.

  5. Submit the job. See Running a Job

Parent topic: Running Dictionary Upgrade Reports