Chapter 6. Module 6: User-Defined Query Category Types

Table of Contents

6.1. Tests & Requirements
6.2. Begin Module 6.
6.3. Retrieve an existing data record in DFexplore.
6.4. Apply a user-defined Query Category query.
6.5. Add a reason for Data Value to explain entered data.
6.6. Edit an existing query.
6.7. Remove a user-defined Query Category that is used by an existing query.
6.8. Delete a user-defined Query Category query.
6.9. End Module 6.

6.1. Tests & Requirements

  1. Retrieve an existing data record in DFexplore.

  2. Apply a user-defined Query Category query.

  3. Add a reason for Data Value to explain entered data.

  4. Edit an existing query.

  5. Remove a user-defined Query Category that is used by an existing query.

  6. Delete a user-defined Query Category query.

Estimate of Time Required: 30 Minutes

6.2. Begin Module 6.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 6 followed by Begin to begin this module.

6.3. Retrieve an existing data record in DFexplore.

  1. Start DFexplore.

  2. Enter the name for DFdiscover Server that has been provided by your administrator. Enter valid1 in the Username field and the previously assigned password in the Password field. Click Login to login.

  3. From the list of available studies, select the 254 Acceptance Test Study and click OK.

  4. Select Select > Change Mode & Level. Within the dialog, set:

    • Mode = Validate

    • Save level = 1 - Level 1

    • Check (enable) Enable edit checks

    Click OK to apply these settings.

  5. Double-click the folder for Site 99 and then double-click subject 99007 in the record list to open the subject binder. Locate the 0: Screening Visits in the list of assessments for subject 99007, and double-click this entry to open task records for this subject. Press Tab to advance through the fields until Screen 2, Reading 1 systolic blood pressure becomes the current field.

6.4. Apply a user-defined Query Category query.

  1. With Screen 2, Reading 1 systolic blood pressure as the current field, select Field > Add Query to open the Add Query dialog. In dialog, confirm that Test, Monitor and Clinical QC are present in the Category pull-down list. Set:

    • Category = Test

    • Use = External

    • Type = Clarification

    • Status = New query

    • Detail = This value is out of our reference range. Please review.

  2. Click OK to apply the query to the Screen 2, Reading 1 systolic blood pressure field. Note that the field becomes blue. Examine the details in the Query window that appears near the bottom left of the screen.

  3. Press Tab to advance through the remaining fields on the page without making any changes. Press Tab to advance to the save buttons at the bottom of the data screen to make them active. Click Incomplete to save the page.

6.5. Add a reason for Data Value to explain entered data.

  1. With Blood Pressure Screening Visits as the active page, press Tab to advance through the fields until Screen 2, Reading 1 systolic blood pressure becomes the current field. Select Field > Add Reason For Data Value or click to open Reason for Data Value dialog.

  2. Enter The value 180 mmHg for systolic blood pressure has been confirmed. Clinical significance is being evaluated. in the Reason field.

  3. Click OK to apply the reason to the Screen 2, Reading 1 systolic blood pressure field. Note that this field is the current field and the field becomes orange. Examine the details in the Reason window that appears near the bottom left of the screen.

    [Note]Note

    If a user-defined Query Category Code is specified as auto-resolution in DFsetup, adding a reason to a field that has a query with such a problem type will change the query status from outstanding to pending.

  4. From the Screen 2, Reading 1 systolic blood pressure field, press Tab to advance through the remaining fields on the page without making any changes. Press Tab to advance to the Save buttons at the bottom of the data screen to make them active. Click Final to save the page to the database.

6.6. Edit an existing query.

  1. Select View > Queries. Select Show > Pending Queries to display all pending queries for Site 99 - Hospital #99.

  2. Double-click entry for subject 99007, Screening Visits: Form 1 to be taken directly to the page and the pending field.

  3. In Data View, select Select > Change Mode & Level. In the dialog, set:

    • Mode = Validate

    • Save level = 2 - Level 2

    • Check Enable edit checks

  4. Click OK to apply and close the Change Mode & Level dialog. The current field is Screen 2, Reading 1 systolic blood pressure.

  5. Select Field > Edit Query or click . In the dialog,

    • Set Use as Internal

    • Delete the existing text in the Detail field

    • Enter See Reason for Data Value. in the Note field

    Click OK to apply the edits.

  6. From the Screen 2, Reading 1 systolic blood pressure field, press Tab to advance through the remaining fields on the page without making any changes. Press Tab to advance to the save buttons at the bottom of the data screen to make them active. Click Final.

  7. Select File > Exit to close and exit DFexplore.

6.7. Remove a user-defined Query Category that is used by an existing query.

  1. Start DFsetup.

  2. In the DFsetup login dialog, enter the name for DFdiscover Server that has been provided by your administrator. Enter datafax in the Username field and the previously assigned password in the Password field. Click Login to login.

  3. Highlight the entry for 254 Acceptance Test Study. Click OK to continue.

  4. Choose Normal Access and click OK.

  5. Select View > Query Category Map.

  6. In the Query Category Map dialog, locate the entry that has Query Category Code 30 and Label Test. Click entry to highlight it, then click Delete. Click Save and Done.

  7. Select File > Exit to close DFsetup.

6.8. Delete a user-defined Query Category query.

  1. Start DFexplore.

  2. In the DFexplore login dialog, enter the name for DFdiscover Server that has been provided by your administrator. Enter valid1 in the Username field and the previously assigned password in the Password field. Click Login to login.

  3. Select 254 Acceptance Test Study then click OK to open its database.

  4. Double-click the folder for Site 99 - Hospital #99 to display a list of available subjects. Double-click subject entry 99007 in the subject list to open the subject binder. Locate the 0: Screening Visits assessment for subject 99007 and double-click this entry. Press Tab to advance through the fields until Screen 2, Reading 1 systolic blood pressure becomes the current field. Examine the details in the Query window. If an existing query contains a user-defined problem type, and that problem type definition has been removed from DFsetup, the query in DFexplore displays Query Category Code 30 as category.

  5. Select Field > Delete Query.

  6. Click OK to perform the query deletion.

  7. Click Delete in the confirmation dialog.

  8. Press Tab to advance through the remaining fields on the Blood Pressure Screening Visits page until the save buttons at the bottom of the screen become active. Click Final.

  9. Click File > Exit to exit DFexplore.

6.9. End Module 6.

  • Click End to confirm successful completion of Module 6.