Chapter 13. Module 13. Replying to EDC Queries, eSignatures

Table of Contents

13.1. Tests & Requirements
13.2. Begin Module 13. Replying to EDC Queries, eSignatures.
13.3. Determine a count of outstanding/outstanding queries in Status View.
13.4. Review outstanding queries in Queries View.
13.5. Using EDC, locate and reply to outstanding clarification queries.
13.6. Add an Electronic Signature (eSign) to a set of completed subject records.
13.7. End Module 13. Replying to EDC Queries, eSignatures.

13.1.  Tests & Requirements

  1. Determine a count of outstanding/outstanding queries in Status View.

  2. Review outstanding queries in Queries View.

  3. Using EDC, locate and reply to outstanding clarification queries.

  4. Add an Electronic Signature (eSign) to a set of completed subject records.

Estimate of Time Required: 30 Minutes

13.2. Begin Module 13. Replying to EDC Queries, eSignatures.

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

  2. Click 13. Replying to EDC Queries followed by Begin to begin this module.

13.3. Determine a count of outstanding/outstanding queries in Status View.

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

  2. Select View > Status. Examine the Queries table to view the status and count of all queries.

  3. Locate the Outstanding column that displays a count of 17 in the Total row. Double-click 17 to retrieve the records containing the 17 outstanding queries.

  4. In the Database Status task Specification dialog set:

    • Mode = Validate

    • Save level = 1 - Level 1

    • Check (enable) Enable Edit checks

    • Search queries and open check (enable) Queries View?

    Click Yes to display a dialog confirming the retrieval. In the confirmation dialog, click OK to open Queries View.

13.4. Review outstanding queries in Queries View.

  1. Select Show > Outstanding Queries to verify that you are seeing only outstanding queries for subjects in Site 99 - Hospital #99.

  2. Examine Queries View to confirm:

    • The Status & Replies column displays Outstanding (New, in report and sent) for all queries.

    • An entry exists for Subject 99001, Screening Visits Form 1, 5. Patient has signed informed consent.

    • An entry exists for Subject 99007, Screening Visits Form 1, Screen 1 Reading 1 systolic.

13.5. Using EDC, locate and reply to outstanding clarification queries.

  1. Locate the entry for Subject 99001, Screening Visits Form 1, 5. Patient has signed informed consent. Double-click the query to switch to Data View and make the queried page and field active. Examine the information present in the Query window.

  2. Select Field > Reply to Query or click . In the dialog, enter Informed consent was sent to study coordinator by email on March 20. in the New Reply field.

  3. Click OK to apply the reply to the queried field. Examine the information present in the Query window.

  4. Do not enter or change data in any of the remaining fields on the current page. Click Final to save the current page and the query reply to the database.

  5. From the record list window, click Return to Queries View. Examine the list of queries.

  6. Locate the entry for Subject 99007, Screening Visits: Form 1, Screen 1: Reading 1 systolic. Double-click the systolic blood pressure query to switch to Data View and make the queried page and field active. Examine the information present in the Query window.

  7. Select Field > Reply to Query or click in the dialog, enter Systolic reading was entered incorrectly. It should be 170. in the New Reply field.

  8. Click OK in the Reply to Query dialog to apply the reply to the queried field. Examine the information present in the Query window.

  9. Click Final to save the current page and the query reply to the database.

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

13.6. Add an Electronic Signature (eSign) to a set of completed subject records.

[Note]Note

eSignatures require password permission to be set in the user role at the DFadmin level. The Password permission must be granted for the specific eSignature plate.

  1. Start DFexplore, login as user site_invest and open the 254 Acceptance Test Study as described in (Section 1.7, “How to start DFexplore).

  2. As user site_invest has 2FA enabled, enter security code recieved by email as previously defined.

    [Note]Note

    Refer to Section 1.8, “Creating user accounts and assigning study permissions.” as a valid email address is required for site_invest to receive 2FA codes.

  3. Select File > Preferences, click Background Options to expand the preferences. Click Color > OK to apply the changes.

  4. Locate subject 99003, double-click its entry to expand a list of visits for Subject 99003.

  5. Double-click 30 : Study Termination. Select 7: Form 7 to open a new STUDY TERMINATION form.

  6. Click anywhere in the screen background to begin data entry. Enter the form data as shown below:

  7. Press Tab to advance to the Investigator's Signature field. This field and the remaining fields on the page are used to capture eSignature name, date and time, respectively. Attempt to enter any name in the Investigator's Signature field.

  8. Press Tab to advance to the remaining 2 eSignature fields. Again attempt to manually enter data into each of these fields. Press Tab to exit the last field on the page (eSignature time) to make the save buttons active.

  9. Click Final to save and eSign the STUDY TERMINATION form.

  10. In the dfpassword confirmation dialog enter the user name site_invest and the corresponding password used for login in Section 13.6, “Add an Electronic Signature (eSign) to a set of completed subject records.”. Click Sign to apply the electronic signature to the current STUDY TERMINATION page.

  11. Examine the 3 eSignature fields at the bottom of the page.

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

13.7. End Module 13. Replying to EDC Queries, eSignatures.

  • Return to the DFATK application. Click End to confirm successful completion of Module 13. Replying to EDC Queries, eSignatures.