Chapter 14. Module 14. Re-submitting Query Corrections

Table of Contents

14.1. Tests & Requirements
14.2. Begin Module 14. Re-submitting Query Corrections.
14.3. Submit PDF images to DFdiscover.
14.4. Verify that all CRFs have arrived successfully in Image view.
14.5. Retrieve submitted CRFs using DFexplore Image View.
14.6. Enter Form 2, Subject 99001, resolve outstanding queries, and save the corrected CRF to the database.
14.7. Enter Form 2, Subject 99002, resolve outstanding queries, and save the corrected CRF to the database.
14.8. Enter Form 4, Subject 99004.
14.9. Enter Form 2, Subject 99004, resolve outstanding queries, and save the corrected CRF to the database.
14.10. Select and resolve a query in a field that has multiple queries.
14.11. Review and approve a pending query reply for Form 1 for Subject 99002.
14.12. Review, correct and approve a pending query reply for Form 1, Subject 99007.
14.13. Confirm query resolution by examining the database status.
14.14. End Module 14. Re-submitting Query Corrections.

14.1. Tests & Requirements

  1. Submit PDF images to DFdiscover.

  2. Verify that all CRFs have arrived successfully in Image view.

  3. Retrieve submitted CRFs using DFexplore Image View.

  4. Enter Form 2, Subject 99001, resolve outstanding queries, and save the corrected CRF to the database.

  5. Enter Form 2, Subject 99002, resolve outstanding queries, and save the corrected CRF to the database.

  6. Enter Form 4, Subject 99004.

  7. Enter Form 2, Subject 99004, resolve outstanding queries, and save the corrected CRF to the database.

  8. Select and resolve a query in a field that has multiple queries.

  9. Review and approve a pending query reply for Form 1 for Subject 99002.

  10. Review, correct and approve a pending query reply for Form 1, Subject 99007.

  11. Confirm query resolution by examining the database status.

Estimate of Time Required: 30 Minutes

14.2. Begin Module 14. Re-submitting Query Corrections.

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

  2. Click 14. Re-submitting Query Corrections followed by Begin to begin this module.

14.3. Submit PDF images to DFdiscover.

  1. Click Send Query Corrections to email a copy of QC_corrections.pdf to site_monitor. Clicking more than once will result in multiple pages arriving to your email inbox.

    [Note]Note

    Save the QC_corrections.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.

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

  3. Click Add. From the Select PDF Files file selection dialog, locate the previously saved QC_corrections.pdf file. Select the file, Click Open.

    [Note]Note

    Documents can also be added by dragging-and-dropping the desired PDF files from a local file folder directly into the list area.

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

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

  6. Click Show Log to confirm successfull transmission of the QC_corrections.pdf file to DFdiscover.

  7. Select File > Exit.

    [Note]Note

    Wait 2-3 minutes prior to proceeding to DFexplore.

14.4. Verify that all CRFs have arrived successfully in 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. Select File > Preferences. In the Preferences dialog, click from Image View section. Select (enable) When the revised record is saved. Click OK to save and close the Preferences dialog.

  3. Select View > Status. Examine the information displayed for the Images awaiting review in Image Queue, Data Records and Queries tables.

    [Note]Note

    The number of pages awaiting review in the Image Router may be different from that shown here as this number includes pages for all studies on the DFdiscover server, not only those that belong to the 254 Acceptance Test Study.

14.5. Retrieve submitted CRFs using DFexplore Image View.

  1. Select View > Image, in the resulting Automatic Retrieval dialog set:

    • Check (enable) Enable Edit Checks

    • Save level = 1 - Level 1

    • Select = document

    • By Age = oldest

    • Quantity = 10

  2. Click OK to bring forward all new images awaiting data entry.

14.6. Enter Form 2, Subject 99001, resolve outstanding queries, and save the corrected CRF to the database.

  1. With PATIENT ENTRY FORM for Subject 99001 as the current page, click anywhere on the page background to make the page active for data entry. Beginning with the Patient Number field, verify that the correct Subject 99001 is displayed. If the Patient Number is incorrect, correct it by selecting Plate > Change Barcode, specify a Subject of 99001. Click OK. Press Tab to exit the field.

    [Note]Note

    In your normal image entry process, you must always pay careful attention to the accuracy of the ICR data. You will need to do the same here. It is possible that the new pages contain ICR errors that you will need to correct during entry. In particular, it is important that you correct any key fields (visit and/or subject numbers) that may have been misread as these are critical to the identification and storage of the data. Note that the ICR data records on your screen may not match exactly those shown in the examples throughout this module.

  2. Click OK to load the data from the existing subject 99001, PATIENT ENTRY FORM.

  3. Press Tab to advance from field to field, and verify that data is the same as that found on the CRF image. Note that some fields may contain values that have been assigned by edit checks. Stop when the Smoking Status field becomes the current field. Examine the details in the Query window. Enter the data as it appears on the image.

    [Note]Note

    When data is entered into a field that contains an outstanding missing value query of type Correction, the query is automatically resolved by DFdiscover as the missing data has now been provided. The color green indicates that the query has been resolved.

  4. Continue tabbing through the remaining fields on the page to verify that the data in the fields is the same as the CRF image. Once the save buttons become active at the bottom of the record, click Final to save the corrected page.

  5. Using the scroll bars, examine the primary image and locate the corrected Smoking Status field to verify that this is the same image that was saved with the corrected data record in Section 14.6, “Enter Form 2, Subject 99001, resolve outstanding queries, and save the corrected CRF to the database.”. Click Cancel to exit the Review Images dialog.

  6. Return to the saved page for Subject 99001 by selecting it from the Image Queue list. Examine the bottom right corner of the main data entry screen.

14.7. Enter Form 2, Subject 99002, resolve outstanding queries, and save the corrected CRF to the database.

  1. From the new Image Queue, click the 2nd entry in the list (Subject 99002) to make it the current page. Click anywhere on the page background to make the page active for data entry. Beginning with the Patient Number field, enter the correct subject 99002 and press Tab to exit the field.

  2. Click OK to load the data from the existing Subject 99002, PATIENT ENTRY FORM.

  3. Press Tab to advance from field to field, and verify that data is the same as that found on the CRF image. Stop when the Date of Birth field becomes the current field. Examine the details in the Query window.

  4. Enter the corrected date value 05/12/51, as it appears on the image of the CRF. With Date of Birth as the current field, select Field > Edit Query or click .

  5. Select Resolved corrected from the Status pull-down. Click OK to apply the change to the query status. Examine the Query window.

  6. Continue tabbing through the remaining fields on the page to verify that the data in the fields is the same as the CRF image. Note that some fields may contain values assigned by edit checks. Once the save buttons at bottom of the record become active click Final to save the corrected page.

  7. Using the scroll bars, examine the primary image and locate the corrected Date of Birth field to verify that this is the same image as was saved with the corrected data record in Section 14.7, “Enter Form 2, Subject 99002, resolve outstanding queries, and save the corrected CRF to the database.”. Click Cancel to close the Review Images dialog.

14.8. Enter Form 4, Subject 99004.

  1. Click anywhere on the page background to make the page active for data entry. Beginning with the Medications Page Number field, enter 1 as shown on the CRF image. Press Tab to exit the field and move to the Patient Number. Enter the number shown on the CRF image and leave the field.

    [Note]Note

    The CURRENT MEDICATIONS form for Subject 99004 has been flagged as Missing in the Query report of Module 12. As a result, arrival of this plate will not trigger the Duplicate Record warning because the page does not currently exist in the study database.

  2. Enter all fields on the data record as they appear on the CRF image. Once the save buttons at bottom of the record become active, click Final to save the entered page.

    [Note]Note

    The Review Images window does not appear upon saving Form 4, Subject 99004 because a duplicate page does not exist for this set of keys.

14.9. Enter Form 2, Subject 99004, resolve outstanding queries, and save the corrected CRF to the database.

  1. Click anywhere on the page background to make the page active for data entry. Beginning with the Patient Number, enter 99004 as shown on the CRF image. Press Tab to exit the field.

  2. Click OK to load the data from the existing Subject 99004, PATIENT ENTRY FORM.

  3. Press Tab to advance from field to field, and verify that data is the same as that found on the CRF image. Note that some fields may contain values assigned by edit checks. Stop when the queried Pulse field becomes the current field. Examine the details in the Query window.

  4. Enter the correct response as it appears on the image of the corrected CRF. Examine the details in the Query window and press Tab to exit the corrected Pulse field.

  5. Continue tabbing through the remaining fields on the page to verify that the data in the fields is the same as the CRF image. Once the save buttons at the bottom become active, click Final to save the corrected page to the database.

  6. Using the scroll bars, examine the primary image and locate the corrected Pulse field to verify that this is the same image as was saved with the corrected data record in Step 3. Click Cancel to close the Review Images window.

14.10. Select and resolve a query in a field that has multiple queries.

  1. With the ADVERSE EVENT REPORT Form for Patient Number 99002 as the current plate, click anywhere on the page background to make the page active. Beginning with the Adverse Event Report No. field, enter the value as shown on the CRF image. Press Tab to exit this field and advance to the AE Identifier field. Upon entering the AE Identifier field, the edit check AESEQNUM2 automatically complete this field. Press Tab to exit the AE Identifier field to advance to the Patient Number field. Verify that the correct Subject 99002 is displayed for the Patient Number field. If the number is incorrect, correct it and press Tab to exit the field.

  2. Click OK to load the data from the existing Subject 99002, ADVERSE EVENT REPORT FORM.

  3. Correctly enter each data field on the page per the CRF image, up to the Intensity field. Confirm that the Intensity field has a value of 4, and contains 2 unresolved queries.

  4. Enter the correct value 2 for Intensity field per the CRF image. Examine the details in the Query window.

  5. Select Field > Edit Query or click . Choose Resolved corrected from the Status pull-down. Click OK to apply the edits.

  6. With the focus still on the Intensity field, examine the details in the Query window. Select the Clinical QC query from the Query drop-down, and examine its details.

  7. Select Field > Edit Query or click in the dialog, choose Resolved corrected from the Status pull-down. Click OK to apply the edits.

  8. Press Tab to advance through the fields, and verify that the data is the same as that found on the CRF image. Note that upon leaving the Description field, an edit check is executed and DFlookup:aecodes dialog appears. Click Cancel to close the DFlookup:aecodes dialog.

  9. Continue tabbing through the remaining fields on the page and verify that the data in the fields is the same as the CRF image. Once the save buttons become active at the bottom of the record, click Incomplete to save the corrected page to the database. Upon clicking Incomplete, the Review Images dialog appears. Click Cancel to close the Review Images window.

14.11. Review and approve a pending query reply for Form 1 for Subject 99002.

  1. Select View > Queries.

  2. Click OK in the confirmation dialog to release the Image View records and open Queries View.

  3. Select Show > Pending Queries to display only queries for which a resolution is pending. Double-click Site 99 - Hospital #99 entry to display all pending queries.

  4. Locate the pending query for Subject 99001, 5. Patient has signed informed consent. Double-click the query to make the queried field and page the current page. Examine the information in the Query window.

  5. Select Field > Approve Queries and Reasons to review all queries and reasons that are present on the current page.

  6. Choose Resolved corrected from the Status pull-down. Enter Signed informed consent was received March 20, 2009. in the Note field.

  7. Click Save to apply the Resolved corrected status to the query. Click Done to close the Approve Queries and Reasons dialog.

  8. Do not change any other data or metadata on the 0 : Screening Visits page for Subject 99001. Make the save buttons at the bottom of the screen active and click Final to save the data record and query to the database.

  9. In the record list window, click Return to Queries View to return to Queries View to process the pending query for Subject 99007.

14.12. Review, correct and approve a pending query reply for Form 1, Subject 99007.

  1. Locate the pending query for Subject 99007, Screen 1: Reading 1 systolic. Double-click the query to make the queried field and page current. Examine the information in the Query window.

  2. Select Field > Approve Queries and Reasons to review all queries and reasons that are present on the current page.

  3. Choose Resolved corrected from the Status pull-down.

  4. Click Save to apply the Resolved corrected status to the query. Click Done to close the Approve Queries and Reasons dialog.

  5. The query reply indicates that the Screen 1: Reading 1 systolic value should be 170. With the focus still on the Screen 1: Reading 1 systolic field on the page, change the value to 170.

  6. Click Final to save the data record and query to the database.

  7. In the record list window, click Return to Queries View to return to Queries View.

14.13. Confirm query resolution by examining the database status.

  1. Select View > Status. Examine the information displayed for the Image Queue, Data Records and Queries tables.

  2. Select File > Exit to close Status View and exit DFexplore.

14.14. End Module 14. Re-submitting Query Corrections.

  • Return to the DFATK application. Click End to confirm successful completion of Module 14. Re-submitting Query Corrections.