Chapter 17. Module 17. DFweb Data Entry

Table of Contents

17.1. Introduction
17.2. Tests & Requirements
17.3. Begin Module 17. DFweb Data Entry.
17.4. Verify DFweb version information, logging into DFweb and DFweb site certificate verification.
17.5. Copying URL and changing user passwords.
17.6. Creating a new subject, entering subject data.
17.7. Adding, modifying and resolving queries.
17.8. Adding, reviewing and downloading subject documents.
17.9. End Module 17. DFweb.

17.1. Introduction

[Warning]Warning

Optional Module.  The DFweb Data Entry module requires the DFWS feature (web services API). If your DFdiscover server is not licensed for this feature, do not complete this module.

DFweb is compatible with all web browsers that support the HTML5 standard, including the following web browsers:

  • Chrome

  • Safari

  • Edge

  • Firefox on Windows 10

17.2. Tests & Requirements

  1. Verify DFweb version information, logging into DFweb and DFweb site certificate verification.

  2. Copying URL and changing user passwords.

  3. Creating a new subject, entering subject data.

  4. Adding, modifying and resolving queries.

  5. Adding, reviewing and downloading subject documents.

Estimate of Time Required: 15 Minutes

17.3. Begin Module 17. DFweb Data Entry.

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

  2. Click 17. DFweb followed by Begin to begin this module. Click Send ID 99008.

[Note]Note

Save the labresults99008_module17.pdf file received via email to your local computer. This file is required to complete Section 17.8, “Adding, reviewing and downloading subject documents.”. Refer to Section 1.8, “Creating user accounts and assigning study permissions.” as a valid email address is required for data_coordinator, data_manager, site_monitor or site_invest to receive the module specific PDF files.

17.4. Verify DFweb version information, logging into DFweb and DFweb site certificate verification.

[Note]Note

All remaining tests performed in this module have been completed using Google Chrome. Results and/or test steps may vary with other browsers.

  1. Open a web browser and navigate to https://dfweb.dfdiscover.com/login, verify the version information: DFweb Version 5.3.X is displayed.

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

  3. A list of subjects for Site 99 is displayed.

  4. Click from the web browser address bar. Select Certificate. The website trust certificate is displayed for the current DFweb address, click OK to close the window.

17.5. Copying URL and changing user passwords.

  1. From the Subjects list, click Subject 99002 to open the 0: Screening Visits 1:Form 1 page.

  2. Copy the DFweb URL by clicking > Copy URL.

  3. Open a new browser tab, paste the copied URL into the new browser tab, click Enter. The pasted URL in the new tab re-directs you to the DFweb login page. Login again using site_monitor credentials, upon logging in you are taken to the same subject data record as the previous web browser tab. Close the web browser tab.

  4. From the breadcrumb bar, click Site 99. Click > Change password to view the Change Password window. Click Cancel.

17.6. Creating a new subject, entering subject data.

  1. From the Subjects list, click Subject 99010 to open the 0: Screening Visits 1:Form 1 page.

  2. Click Patient Initials enter ARX, Set:

    • Age (years) = 49

    • Sex = male

    • Race = caucasian

    • Screen 1 Date = Click icon, select 11-Nov-2018

    Click .

  3. Select 1:Baseline > 21:Lab Results page. Click Patient Initials field.

    [Note]Note

    The SetInit edit check executes upon entry to the field. If the initials are available on 1 : Form 1 (previously entered), they are retrieved and populate the Patient Initials field.

  4. Set the remaining fields within the 21: Lab Results form as follows:

    • Collection Date = 13-NOV-2018

    • White Blood Cell = 15.3, Check (enable) NORMAL

    • Red Blood Cell = 04.3, Check (enable) NORMAL

    • Hemoglobin = 14.2, Check (enable) NORMAL

    • Mean Cell Hemoglobin Conc = 46.5, Check (enable) ABNORMAL

    Click .

17.7. Adding, modifying and resolving queries.

  1. From the breadcrumb bar, click Site 99 > Subject 99008 > 0: Screening Visits > 1: Form 1. Change 6. Systolic and diastolic BP criteria from 'Yes' to 'No', Click then , select Resolved from the Status drop-down list. Click Apply, Close and to save the data record changes.

  2. Click 1: Baseline, and 2: Form 2 becomes the active form. Correct Date of Birth (dd/mm/yy) to 14/01/68.

  3. Click then , select Resolved from the Status drop-down list. Click Apply, then Close to save the query changes. Click .

  4. Click 21: Lab Results. To the right of the Mean Cell Hemoglobin Conc ABNORMAL/NORMAL field click . Enter Lab value confirmed as out of range. in the Reason field. Click Apply, followed by .

17.8. Adding, reviewing and downloading subject documents.

  1. With subject 99008 21: Lab Results still the current record. Click > Manage documents to open the Manage documents window.

  2. Click Choose Files, select the previously saved labresults99008_module17.pdf (Refer to Step 2). Click Open > Upload to upload the document.

  3. Click to view the newly uploaded document.

  4. The document can be zoomed in/out by using the navigation buttons within the document window.

  5. Click Close to close the Manage Documents window. Notice the icon has now changed to indicating the data record now has associated documents.

  6. Click > Logout to exit DFweb.

17.9. End Module 17. DFweb.

  • Return to the DFATK application. Click End to confirm successful completion of Module 17. DFweb.