VTA and VTI Maintenance Reports

The following are VTA Maintenance reports:

• Nonapproved VTs Report
  
• Classification to a New Domain Report
  
• Verbatim Term Modifications Report
  
• X Areas with Outstanding Changes Report
  

Nonapproved VTs Report

The Non Approved VTs report displays nonapproved VTs in chronological order, with the most recent first. It also displays actions and notes associated with the VTs.

Note:

You can generate this report in MS Excel.

The Non Approved VTs report provides the following information about VTs:

• The dictionary and domain names

• The verbatim term

• Dictionary term to which the VT maps

• The dictionary term's level

• The VT's status

• The user ID of the person who created the VT

The report provides the following information about actions:

• The dictionary and domain names

• The verbatim term

• The action text

• The action code as it appears in TMS

• The action description

• The user ID of the person who created the action

To run the Non Approved VTs report:

1. Select the Nonapproved VTs Report from the VTA Maintenance menu.
2. Fill in the general report specifications. See Setting Parameters.
3. Enter a value for each job-specific parameter:

   • Active Dictionaries: Select the dictionary from the list of active dictionaries, for which you want to run this report.

   • Domain: You can optionally select a domain if you want the domain name to appear in the report along with the dictionary name.

     Note:

     If you select a domain here that does not contain the dictionary you want to run the report for (selected in Active Dictionaries above), then your report will not show any data.

   • 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.

Classification to a New Domain Report

This report is useful when you are planning to move to a new domain and a different dictionary or a new rendition of the same dictionary; for example from WHO-ART to MedDRA. This report displays information about the amount of recoding that is required for this move. You can use the Copy Domain feature to make the coding similar in the two domains, if you so require. See Copying Domains.

The report displays:

• The omissions that will remain omissions

• The omissions that will be resolved (VTAs or VTIs)

• The VTAs and VTIs that will remain VTAs or VTIs

• The VTAs and VTIs that will be reclassified

• The VTAs and VTIs that will be declassified (omissions)

For each verbatim term, the report displays:

• The term type (VTA or VTI)

• The VT status and ID

• The original domain's dictionary term and its ID

• The new domain's dictionary term and its ID

To run the Classification to a New Domain Report:

1. Select the Classification to a New Domain Report from the VTA Maintenance menu.
2. Fill in the general report specifications. See Setting Parameters.
3. Enter a value for each job-specific parameter:

   • Original Domain: Select the domain from which you are moving your classifications.

   • Original Dictionary: Select the dictionary under the original domain from which the VTAs need to be reclassified.

   • New Domain: Select the domain to which you are moving the VTA classifications.

   • New Dictionary: Select the dictionary under the new domain to which the VTAs will be reclassified.

   • 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.

Verbatim Term Modifications Report

You can keep track of the coding changes that a Verbatim Term (VT) has undergone within a specified time period and data set with the VT Modifications Report. It specifies the type of change in the VT - classification, declassification, reclassification and applied actions. You can also view the author of the change and the reason for it.

You can confine your search to a verbatim term in a particular external system or include all external systems. You can define an External Value to narrow your search to a particular data set. For example, in Oracle Clinical, you can define an External Value as a study and assign an External Value Number to each study. TMS generates a report based on the specified study only.

The Verbatim Term Modifications Report displays the following:

• Dictionary: The selected dictionary or dictionaries on which the report is run.

• Domain: The active domain or domains on which the report is run.

• Verbatim Term: The Verbatim Term queried.

• External Value: This indicates the query criteria, if any.

• VT Status: The changes undergone by the VT (classification, declassification, reclassification and applied actions), the coder User ID, and the time of change.

• Dictionary Term & Action Text: This is the Dictionary Term for an approved VTA. For an Action, the Action text is displayed.

To run the Verbatim Term Modifications Report:

1. Select VTA maintenance in the navigator window.
2. Select Jobs.
3. Select VT Modifications.
4. Fill in the general report specifications. See Setting Parameters.
5. Enter a value for Job Specific parameters:

   • Active Dictionaries: Choose the dictionary on which to run the report. TMS searches all dictionaries by default.

   • Domain: Select the appropriate domain. TMS searches all domains by default.

   • Coder User Name: Select the User Name of the coder.

   • External System: Select the relevant External System.

   • External Value number: Select the relevant External Value Number from the field. If not coded in the External System, the report displays External Value Number as N/A.

   • External Value: This field is activated only if the External Value Number is already selected. The value corresponds with the External Value Number as pre-defined.

   • Verbatim Term: Type in the Verbatim Term to be queried.

   • Start Date: Type in the Start Date of the time period for which to run the report. Use the MM-DD-YYYY format where MM is the first three letters of the month. The default date is JAN-01-1900.

   • End Date: Type in the End Date of the time period for which to run the report. Use the MM-DD-YYYY format where MM is the first three letters of the month. The default date is AUG-15-3501.

   • 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.

6. Submit the job. See Running a Job.

X Areas with Outstanding Changes Report

This report displays X Areas for which the data exchange job between the external system and TMS should be run. If the external system is Oracle Clinical, an X Area is a study, and the report displays the study names for which Batch Validation should be run.

If you are not running the data exchange job on a regular basis—for example, you have finished data collection in a study—you can run this job to detect X Areas where data cleaning in the external system or changes such as reclassifications in TMS have produced data changes that should be propagated to the other system.

If the external system is not Oracle Clinical, you can write a function to display a meaningful name for X Areas if appropriate; see Defining the External System in TMS and Defining Views and Functions in the External System.

The report displays the X Area and other external system information for:

• omissions that originated in all instances

• source terms that originated locally only

To run the report, do the following:

1. Fill in the general report specifications. See Setting Parameters.
2. Enter values for the following job-specific parameters:

   • External System. Select the external source data system whose X Areas you want to know about.

   • Template. Select a template; if your company has created a custom template, it appears in the drop-down list. The Oracle template is the default.

3. Submit the job. See Running a Job.