Chapter 10. Module 10. Multiple Queries Per Field

Table of Contents

10.1. Tests & Requirements
10.2. Begin Module 10. Multiple Queries Per Field.
10.3. Submit PDF images to DFdiscover.
10.4. Enable multiple queries per field in DFsetup.
10.5. Retrieve submitted CRF in DFexplore Image View.
10.6. Enter Plate 9 for Subject 99002.
10.7. Apply multiple queries to a field.
10.8. Select and edit an existing query in a field that has multiple queries.
10.9. Select and reply to an existing query in a field that has multiple queries.
10.10. Select and delete an existing query in a field that has multiple queries.
10.11. End Module 10. Multiple Queries Per Field

10.1. Tests & Requirements

  1. Submit PDF images to DFdiscover.

  2. Enable multiple queries per field in DFsetup.

  3. Retrieve submitted CRF in DFexplore Image View.

  4. Enter Plate 9 for Subject 99002.

  5. Apply multiple queries to a field.

  6. Select and edit an existing query in a field that has multiple queries.

  7. Select and reply to an existing query in a field that has multiple queries.

  8. Select and delete an existing query in a field that has multiple queries.

Estimate of Time Required: 30 Minutes

10.2. Begin Module 10. Multiple Queries Per Field.

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

  2. Click 10. Multiple Queries Per Field followed by Begin to begin this module.

  3. Click Send ID 99002 to email a copy of ID99002-module10.pdf to site_monitor. Clicking more than once will result in multiple files arriving to your email inbox.

    [Note]Note

    Save the ID99002-module10.pdf file received via email to your local computer. This file is required to complete the remainder of this module. Refer to Section 1.8, “Creating user accounts and assigning study permissions.” as a valid email address is required for site_monitor to receive the module specific PDF files.

  4. The following steps require exclusive access to the 254 Acceptance Test Study database. To facilitate exclusive access, close DFATK by clicking Exit.

10.3. Submit PDF images to DFdiscover.

  1. Start DFsend, login as user site_monitor as described in Section 1.9, “How to start DFsend.

  2. Click Add. From the Select PDF Files file selection dialog, locate the previously saved ID99002-module10.pdf file. Select the file, click Open.

  3. Click Send, enter site_monitor; in the Username field and the previously assigned password in the Password field. Click OK.

  4. In the resulting Send PDFs to DFdiscover dialog, confirm 1 success and 0 failure are shown. Click OK.

  5. Click Show Log to confirm successfull transmission of the ID99002-module10.pdf file to DFdiscover.

  6. Select File > Exit.

10.4. Enable multiple queries per field in DFsetup.

  1. Start DFsetup, login as user data_manager and choose 254 Acceptance Test Study as described in Section 1.8, “How to start DFsetup.

  2. Choose Developer Access in the Access mode dialog, click OK.

  3. The main window for DFsetup is displayed. Select Study > Global Settings.

  4. Click Global tab in the Global Settings dialog.

    Check (enable), if not already checked, Allow Multiple Queries per field.

    The warning message: This CANNOT be undone once the Study Setup is saved is displayed.

  5. Click OK to close the Global Settings dialog.

  6. Select File > Save [Required], followed by File > Exit.

10.5. Retrieve submitted CRF in DFexplore Image View.

  1. Start DFexplore, login as user data_coordinator and choose 254 Acceptance Test Study as described in Section 1.7, “How to start DFexplore.

  2. The main window for DFexplore is displayed. Select View > Image.

  3. In the Automatic Retrieval dialog, set:

    • Save level = 1 - Level 1

    • Check (enable) Enable Edit Checks

    • Select = document

    • By Age = Oldest

    • Quantity __ documents = 10

    • Check (enable) Repeat

    Confirm the settings.

    Click OK.

  4. The first image retrieved is the Adverse Event Report CRF.

10.6. Enter Plate 9 for Subject 99002.

  1. The Adverse Event Report No. field is highlighted as the current field. Enter the value from the CRF image if it is not already correctly auto-filled. Press Tab to advance to the AE Identifier field. The AESEQNUM2 edit check executes upon entry to the AE Identifier field. The data value in the field is updated.

  2. Press Tab to advance to the Patient Number field.

  3. Beginning at the Patient Number field, correctly enter the data per the CRF image, up to and including the Intensity field. Tabbing from the Intensity field, a user-defined edit check executes and the dfaddqc: Severity dialog is displayed.

  4. Click OK to apply the edit check. The field becomes blue, and the next field Relationship to Study Drug becomes the current field.

  5. Correctly enter each data field on the page per the CRF image, up to and including the Description field.

    Do not enter any text in the Description field as the corresponding field on the CRF image is blank. Upon tabbing off this field, the dfaddqc: MissingQC dialog appears.

    Confirm that Missing is displayed in the Category field.

  6. Click OK. This applies the edit check to the Description field. The field becomes blue, and the AECOTERM becomes the current field.

  7. From the AECOTERM field, press Tab through all remaining fields until the Investigator's Signature field becomes the current field.

    Tabbing from the Investigator's Signature field, the DFlookup: investigators dialog appears. Highlight Dr. John Snow and click OK.

  8. Enter the Date field value. Press Tab to advance to the save status bar to make it active. Click Incomplete to save the changes.

10.7. Apply multiple queries to a field.

  1. With the Adverse Event Report displayed as the current page, make the page active by clicking anywhere on the page background using the mouse. Press Tab to advance through the fields until Description becomes the current field. Note that the Description field is blank and has an unresolved query with the category Missing (external, correction). Enter the text Nausea, ??? and fever.

  2. Select Field > Add Query or click . In the dialog, confirm Category type Missing is disabled. Set:

    • Category = Other

    • Use = External

    • Type = Correction

    • Status = New query

    • Detail = Please clarify the word after nausea. The description provided through email is 'Nausea, vamit and fever'. Do you mean Vomit instead?

    [Note]Note

    Multiple queries can be added to a single field, but each query must have a unique Query Category type. Therefore, a Category will be disabled if it has been previously used on the same field where a new query is to be added.

  3. Click OK to apply the query. Confirm that the Description field is the current field with the query count '2' displaying on the top left corner of the field widget, and the field becomes blue.

  4. With the focus still on the Description field, examine the details in the Query window that appears at the bottom left corner of the main data entry screen.

  5. Select Field > Add Query or click to add the third query to the Description field. In the dialog, set:

    • Category = Monitor

    • Use = External

    • Type = Correction

    • Status = New query

    • Detail = Nausea and fever are two separate adverse events and should be reported in different CRFs. Please review.

  6. Click OK to apply the query. Confirm that the Description field is the current field with the query count 3 displaying on the top left corner of the field widget, and the field becomes blue.

  7. With the focus still on the Description field, examine the details in the Query window that appears at the bottom left corner of the main data entry screen.

    [Note]Note

    The query list reflects the query sort order that has been defined by the user in DFsetup Query Category Map.

  8. Press Tab to exit the Description field, and a DFlookup: aecodes window appears. Click Cancel in the window to close the dialog. The next field AECOTERM becomes the current field.

  9. 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.

10.8. Select and edit an existing query in a field that has multiple queries.

  1. With the Adverse Event Report page still active, select View > Queries to open the Queries View window. In the resulting confirmation dialog, click OK to release all Image records. Select Show > All Queries. Double-click Site 99 - Hospital #99. Locate and confirm that the Queries window displays the three queries that have been applied to the AE Description field for Subject 99002.

  2. Select Show > Outstanding Queries. Locate and confirm that two unresolved queries with categories Other and Monitor on the AE Description field of Subject 99002 are displayed.

  3. Double-click entry containing the query category Other in the Description field of Subject 99002, Adverse Event 1 Page 1: Form 9, AE Report 011.

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

    • Mode = Validate

    • Save level = 2 - Level 2

    • Check (enable) Enable edit checks

    Click OK to apply the changes.

  5. Delete the text ??? in the description field and enter vomiting instead. Examine the query window. From the Query drop-down choose Other (external, correction) query in the query list.

  6. With the focus on the Other (external, correction) query Description field, select Field > Edit Query, or click the to open the dialog. set:

    • Select Pending from the Status pull-down.

    • Enter The correction was provided via email. in the Note field.

    Click OK to apply the edits.

10.9. Select and reply to an existing query in a field that has multiple queries.

  1. Select Monitor (external correction) from the Query pull-down to make the query active.

  2. Select Field > Reply to Query or click to open the dialog. Enter Fever will be removed to a different Adverse Event Report form. in the New Reply field.

  3. Click OK to close the dialog. Examine the information present in the Query window.

10.10. Select and delete an existing query in a field that has multiple queries.

  1. Choose Missing (external, correction) from the Query pull-down list. The query list in the query window displays the Missing (external, correction) query. Confirm that the first query is defined with Category: Missing (external, correction) and a Status: Resolved corrected.

  2. Select Field > Delete Query or click to open the Delete Query dialog.

  3. Click OK to perform the query deletion.

  4. Click Delete in the Delete Query confirmation dialog. Confirm that the Description field remains as the active field and has the query count 2 displaying on the top left corner of the field widget.

  5. Press Tab to exit the Description field, and a DFlookup: aecodes window appears. Click Cancel in the window to close the dialog. The next field AECOTERM becomes the current field.

  6. Press Tab to advance through the remaining fields on the Adverse Event Report page until the Incomplete at the bottom of the screen becomes active. Click Incomplete to save the modified page.

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

10.11. End Module 10. Multiple Queries Per Field

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

  2. Click End to confirm successful completion of Module 10. Multiple Queries Per Field.