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

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

Open a web browser and navigate to https://dfweb.dfdiscover.com/login, Click Settings, verify the version information: DFweb Version 5.8.X is displayed.

Click X to close the Settings window. In the DFweb login dialog, enter the DFdiscover Server name that has been provided by your administrator. Click Continue.

Enter site_monitor in the Username field and the previously assigned password in the Password field. Click Continue to login.

A list of subjects for Hospital #99 is displayed.

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

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

Copy the DFweb URL by clicking > Copy URL.

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 confirm you are taken to the same subject data record as the previous web browser tab. Close the web browser tab.

Click > User Profile > Change Password to view the Change Password window. Click Cancel.

Click Subjects , select 99010 to open the 0: Screening Visits 1:Form 1 page.

Click Patient Initials enter ARX, Set:

Click .

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

	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.

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

Click to open the Reason for Data Value dialog. Click ... next to Reason. The DFlookup: REASON dialog is displayed.

Select the Result of Confirmed, this value is correct as entered., Click OK, followed by Apply then .

Select 51: Medication Log Page 1 > 8: Form 8, Pg 51 page. Click Patient Initials field.

	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.

Press Tab. In the Medication Log Page Number field, enter values 1 of 1.

Press Tab to advance to 1. Drug Name field. Enter Vitamin B-12 in the 1. Drug Name text field, press Tab. Upon leaving the field, an edit check is executed and DFlookup: drugs dialog appears.

Enter vitamin b12 in the Search Terms, Check Match ALL terms and click to filter the results.

Select the result of vitamin b12 from the table. Click OK. The 1. Drug Name field becomes auto-populated with vitamin b12 result.

Beginning with the Type of Change field complete the remaining data fields as follows:

Click .

Select 1: Baseline > 4 : Form 4, Pg 1. Click > Set Page Missed to open the Set Page Missed dialog.

In the dialog, choose Other Reason value from the Reason pull-down list. Enter Medication information provided on the Medication Log Page. as the Detail.

Click Apply to register the page as missed.

Click Subjects , select 99009 > 1: Baseline > 2: Form 2. Click > Unset Missed Page to open the Unset Missed Page dialog.

Enter a reason of Data to be captured during chart review.. Click Apply

From the sidebar bar, Click . Locate and select the outstanding query for 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.

Click 99008 > 1:Baseline > 2: Form 2. Select Date of Birth (dd/mm/yy) query. Correct Date of Birth (dd/mm/yy) to 14/01/68.

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

Click 21: Lab Results, select the outstanding query. Click . Enter Lab value confirmed as out of range. in the Reason field. Click Apply, followed by .

Click .

Within the Queries Overview dashboard, click Outstanding (Red portion) under the All Queries by Status pie chart. The Queries Overview table is displayed showing all oustanding queries for the site.

In the Queries Overview table locate and select the outstanding query for subject 99009.

Select Asian in the Race field. Click Save.

Return to the Dashboard page by Clicking .

Within the Queries Overview dashboard, click Outstanding under the All Queries by Status pie chart. The Queries Overview table is displayed showing all oustanding queries for the site. Confirm the oustanding query for subject 99009 is no longer present.

From the sidebar, select Subjects > 99008 > 1: Baseline > 21: Lab Results. Click > Manage documents to open the Manage documents window.

Click Choose Files, select the previously saved labreport99008_module17.pdf (Refer to Step 2). Click Open > Upload to upload the document.

Click to view the newly uploaded document.

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

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

Click > Logout to exit DFweb.

In the DFweb login dialog, enter site_invest in the Username field and the previously assigned password in the Password field. Click Login to login.

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

	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.

From the Subjects list, click Subject 99011 > 30: Study Termination > 7: Form 7.

Click Patient Initials enter SIG, Set:

Click to save and eSign the Study Termination form.

In the dfpassword confirmation dialog enter the user name site_invest and the corresponding password. Click Sign to apply the electronic signature to the current page.

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

Click > Logout to exit DFweb.

In the DFweb login dialog, enter site_monitor in the Username field and the previously assigned password in the Password field. Click Login to login.

From the Subjects list, click Subject 99011 > 30: Study Termination > 7: Form 7.

Click 2. Last dose of study medication was taken on field. Click to open the Add Query dialog. In the dialog, set:

Press Tab to advance to the Unknown field. Un-check (disable) the checkbox. Click .

Click > Logout to exit DFweb.

In the DFweb login dialog, enter site_invest in the Username field and the previously assigned password in the Password field. Click Login to login.

From the sidebar, Click Tasks.

Locate the eSignatures - Study Termination - eSignatures task. Click Start.

From the Subjects list, click Subject 99011 > 30: Study Termination > 7: Form 7.

Click the 2. Last dose of study medication was taken on field. Click then . Select Resolved from the Status drop-down list. Enter Confirmed date of last medication dose verbally with subject during clinic visit. in the Note field. Click Apply, Close.

Enter the 2. Last dose of study medication was taken on date as 02/06/22. Click .

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 page.

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

Click Close x to close Tasks view. In the resulting warning dialog click Continue.

Click > Page History to open the Page History window. The Page History is displayed, Click OK to close the window.

Click , enable (toggle on) Grouped View.

Expand (click) Subject Tracking to view the available reports. Select History of Changes.

Click Subject Tracking to view the available reports. Select History of Changes.

Enter 99011 in the Subject field, click Date Range in the resulting dialog select the current date and click OK > Run. The History of Changes report updates to display the requested data. Click X to close the report.

Click > Logout to exit DFweb.