Start DFexplore. In the DFexplore login dialog, enter the name for DFdiscover Server that has been provided by your administrator. (This will differ from the value shown here.) Enter data_coordinator, data_manager, site_monitor or site_invest in the Username field and the previously assigned password in the Password field. Click Login to login.

During the first login of data_coordinator, data_manager, site_monitor or site_invest a new password must be chosen. Choose and enter a new password in both the New Password and Confirm Password fields. Click OK to set the new password and dismiss the dialog. Choose 254 Acceptance Test Study, click Continue. If your DFdiscover server does not allow the re-use of previous passwords, you will be required to set either data_coordinator, data_manager, site_monitor or site_invest's password to something other than the initial password chosen previously. The password you choose must satisfy the password requirements specific to your DFdiscover server and will be needed in the remainder of the modules.

Start DFsetup. In the DFsetup login dialog, enter the name for DFdiscover Server that has been provided by your administrator. (This will differ from the value shown here.) Enter data_manager in the Username field and the previously assigned password in the Password field. Click Login to login.

In the studies selection dialog, highlight the entry for 254 Acceptance Test Study. Click Continue to continue.

Confirm the Acceptance Test Kit is installed on the following Linux operating system:

Confirm DFdiscover version information by starting DFexplore.

In the login dialog, click About. Confirm that the version information in the dialog matches the installed software Version 5.5.X.

If the version is not DFdiscover 2022 Version 5.5.0, you must stop at this point. The Acceptance Test Kit is specifically designed for release DFdiscover 2022 Version 5.5.0.

Exit DFexplore.

Start DFadmin. Login to your DFdiscover Server as datafax.

Specify a Username of datafax, and the assigned user password in the Password field. Click Login to complete login and continue.

Click Status Tab.

The list of studies defined on your DFdiscover Server will be displayed in the studies list.

Select the entry for 254 Acceptance Test Study from the list of studies. Select Action > Disable study. In the confirmation dialog, enter the text Study Removal.

Click Disable to disable the Acceptance Test Kit.

Click Studies tab. Select the entry for 254 Acceptance Test Study if it is not already highlighted. Click Delete.

From the 3 delete options, choose Remove Study from DFdiscover.

Click Delete in the confirmation dialog to continue with the delete.

In the Remove Study dialog, de-select (disable) Archive Study Permissions and click Continue.

To confirm, enter the password for datafax and click OK. Close the study removal confirmation dialog by clicking OK.

Return to DFadmin, select the Studies tab. Add a definition for 254 Acceptance Test Study. Click New and complete the dialog with the following values:

	Note
	The name of your Study Space may differ from that shown here if the Study Space is something other than opt_studies on your DFdiscover server.

Click OK to confirm the action and add an entry for 254 Acceptance Test Study to the list of studies.

Verify configuration information and set the Preset Printer. Select the newly added 254 Acceptance Test Study entry from the list of studies. Click Configurations tab and enter the name of a networked printer in the Preset Printer field.

Choose All minor versions supported from the Version Strict drop-down.

Select File > Save or click Save to save the configuration information.

Click Users tab. Confirm that user datafax is present in the Username column for one user row.

Create a Role for user datafax. Begin this task by clicking the Roles tab.

Within the list of studies, locate and choose the entry for 254 Acceptance Test Study. Click New to add a new user role. In the dialog, enter the role name Unrestricted.

Click Create to create the new role Unrestricted.

Define Tools & Reports permissions for the Unrestricted role. Highlight Unrestricted in the Roles list to make it the active role. Enter Full Permissions in the Description field.

Click Tools & Reports tab below the Description field. Check (enable) each of the following: DFexplore & API Clients, Server & DFsetup, DFdiscover Reports, and Study Reports.

Click Auto Logout tab. If not already enabled, check (enable) the Inherit from Study box to override the default Auto Logout settings with those of the ATK study.

Click Permissions tab.

Set data permissions as follows:

Select File > Save or click Save to save settings for role Unrestricted.

Still as datafax and with the DFadmin application open, click Users tab.

Set permissions for datafax. Click the entry for datafax from the list of users to make it active. Click Permissions tab. Check (enable) Allow access to Image Router.

To assign a study to datafax, click the blank area below the Study heading. Select 254 Acceptance Test Study from the Study drop-down. Set:

Click Save to save the role and permissions for datafax.

Create a Role for user data_coordinator. Begin this task by clicking the Roles tab.

	Note
	If the role already exists, confirm the permissions and settings described in Step 2 to Step 8 and make changes where necessary.

In the list of studies, locate and choose 254 Acceptance Test Study. Click New to add a new user role. In the confirmation dialog, enter the role name data_coordinator.

Click Create in the New Role dialog to apply the role name.

In the Description field enter: Levels 0-4, data entry and meta data.

Click Tools & Reports tab. Check (enable) each of the following: DFexplore & API Clients, Server & DFsetup, DFdiscover Reports, and Study Reports.

Click Auto Logout tab. If not already checked (enabled), check Inherit from Study to override the default Auto Logout setting with the study setting.

Click Permissions tab.

Set data permissions with the following settings:

Click Save to save the role.

Click Copy then Paste, specify a role name of site_investigator. Click Create.

Click Permissions tab.

Enter a Description of eSignature Permissions. Set data permissions as follows:

Click Save.

Still as datafax and with the DFadmin application open, click Users tab to open the user definition window.

Determine if user data_coordinator has already been defined. Review the list of users to determine if an entry exists for user data_coordinator.

	Note
	If an entry for data_coordinator cannot be located in the list of users, complete Step 3 to Step 12 inclusive.

	Note
	If an entry for data_coordinator can be located in the list of users, complete Step 13 to Step 16 inclusive.

Click New/Find to add a DFdiscover account for user data_coordinator. In the dialog, select Create new user enter the Username data_coordinator as shown.

Click OK to add data_coordinator to the list of users. An empty icon represents data_coordinator, the status of data_coordinator is set to Inactive.

Choose the data_coordinator entry from the list of users if it is not already highlighted. Click User Profile tab. Enter these settings:

	Note
	A valid email address is required to receive module specific PDF files if you have not specified a printer in the Master view.

No further user profile information is needed. Click Save.

With user data_coordinator still as the active user, click Permissions tab. Check (enable) Allow access to Image Router.

To assign a study to data_coordinator, click the blank area below the Study heading. Select 254 Acceptance Test Study from the Study drop-down. Set:

Select Active from the Status drop-down list to change the status from Inactive to Active for user data_coordinator.

Assign a DFdiscover password for data_coordinator by clicking New Password. Enter a password of your choice in place of the auto-generated system password.

	Note
	Remember the password assigned in this step as it is needed in future tests.

Save all previously entered permissions, roles and password by clicking Save.

Skip Step 13 to Step 16 and go to Step 17.

Locate and choose the entry for user data_coordinator in the list of users. Click Permissions tab and confirm the following settings. If any of the following permissions do not appear as shown below, set them now.

Verify the status for data_coordinator. If data_coordinator is set to Inactive, select Active from the Status drop-down list.

Assign a DFdiscover password for data_coordinator by clicking New Password. Enter a password of your choice in place of the auto-generated system password.

	Note
	Remember the password assigned in this test step as it is needed in future tests.

Save all previously entered permissions, roles and password by clicking Save.

With data_coordinator as the active user, click Duplicate. In the dialog enter a username of data_manager. Click Create.

Specify a Full Name of data_manager. Click Permissions tab, then ... within the Study or DFdiscover Administrator. Select Study Admin for Selected Studies, check (enable) 254 Acceptance Test Study. Click OK.

Confirm the Study Roles permissions. If any of the following permissions do not appear as shown below, set them now.

Verify the status for data_manager. If data_manager is set to Inactive, select Active from the Status drop-down list.

Assign a DFdiscover password for data_manager by clicking New Password. Enter a password of your choice in place of the auto-generated system password. Click Save.

	Note
	Remember the password assigned in this test step as it is needed in future tests.

Click data_coordinator to make it the active user. Click Duplicate. In the dialog enter a username of site_monitor. Click Create

Specify a Full Name of site_monitor. Click Permissions tab and confirm the following settings. If any of the following permissions do not appear as shown below, set them now.

Verify the status for site_monitor. If site_monitor is set to Inactive, select Active from the Status drop-down list.

Assign a DFdiscover password for site_monitor by clicking New Password. Enter a password of your choice in place of the auto-generated system password. Click Save.

	Note
	Remember the password assigned in this test step as it is needed in future tests.

With site_monitor as the active user, click Duplicate. In the dialog enter a username of site_invest. Click Create

Specify a Full Name of site_investigator. Check (enable) Two-factor authentication required.

Click Permissions tab and confirm the following settings. If any of the following permissions do not appear as shown below, set them now.

Verify the status for site_invest. If site_invest is set to Inactive, select Active from the Status drop-down list.

Assign a DFdiscover password for site_invest by clicking New Password. Enter a password of your choice in place of the auto-generated system password. Click Save.

	Note
	Remember the password assigned in this test step as it is needed in future tests.

To enable high definition imaging, click the Traffic tab. Within that view, click the Inbound tab to display the Inbound view.

Check Enable High Definition Imaging. The Normal Colors checkbox is enabled by default. If it is not, enable it. Click Save to save the settings.

Select File > Exit to close DFadmin.

The remaining steps in this module require datafax privileges. Open the DFATK (Control Panel) login dialog.

Enter the name of the DFdiscover Server on which the Acceptance Test Kit has been installed. As the Acceptance Test Kit Control Panel must be run as datafax, the Username field cannot be edited. Enter the previously specified password for datafax and click Login.

In the Control Panel, confirm that Module 1. Installation and Initialization is the current module and that its status is Not yet performed.

Click End to complete Module 1. Installation and Initialization.

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

Click 2. DFdiscover Client Applications followed by Begin to begin this module.

Click Send Welcome Image to email a copy of Welcome_Fax.pdf to site_monitor. Clicking more than once will result in multiple pages arriving to your email inbox.

	Note
	Save the Welcome_Fax.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.

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

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

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

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

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

Click Show Log to review the DFsend transmission history.

Select File > Exit.

	Note
	Wait 2-3 minutes prior to proceeding to DFexplore.

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

Select Help > Topics to access the documentation. In the documentation window, confirm the documentation version number. Select File > Close to dismiss the documentation window.

Select File > Close Study to exit the study.

In the DFexplore login dialog, Click Image Router to start the Image Router. Locate the Welcome image by selecting the page from the list of documents in the CRF ID panel.

	Note
	Any pages that have been received and which DFdiscover could not identify as CRFs for any of the studies registered at your site, will be found in the Image Router. The Welcome image is added during initialization of the module. If there are more pages than the Welcome image in your Image Router window, you may need to locate the Welcome image in the list of images in the CRF ID panel.

Print the Welcome image from the Image Router by selecting Page > Print. Choose your locally installed printer, choose All for Page Range, and click Print.

Delete the Welcome image from the Image Router by selecting Action > Discard. Click OK to confirm the discard action.

Select File > Close Image Router to exit the Image Router.

The study selection dialog is presented.

In the study selection dialog, highlight the entry for 254 Acceptance Test Study. Click Continue.

	Note
	If this step is performed within 60 seconds of closing the Image Router window, the Username, Password and list of studies are still visible. If more than 60 seconds have elapsed, you will first need to re-enter the Password for data_manager, and click Login to view the study selection dialog. Then highlight the entry for 254 Acceptance Test Study and click Continue.

Select File > Preferences. In the Preferences dialog, open each panel and set the options exactly as illustrated. When finished, click OK to save the settings and close the dialog.

Select View > Image to make Image view the current view. Set Quantity = 25. Do not change any other settings in the Automatic Retrieval dialog and click OK to retrieve the new documents.

Note

The record retrieval dialog displays the last retrieval mode from the session preferences for each user on each computer. If data_manager previously used DFexplore in another mode, you may not see the Automatic Retrieval dialog that is illustrated. You may see a different record retrieval dialog. When this happens, click Cancel in that record retrieval dialog. Then select Select > Automatic Retrieval and, as necessary, correct the settings in the resulting dialog so that they match the illustration.

Image view becomes the current view, 12 new records are displayed in the record list panel, and the first record is highlighted. The main window displays the data record in the top pane and document image in the bottom pane.

Select View > Data to change to Data view. In the confirmation dialog, click OK to release the set of image records.

Double-click the entry for Site 99 - Hospital #99 in the record list panel. The site opens to display the subject list. The subject list displays all enrolled subjects and the next 5 potential subjects for the site.

Double-click the entry for Subject 99004 to list all visits for that subject. Select Subject > Expand All Visits. In the record list panel, locate the 6: Form 6 entry belonging to the 30 : Study Termination visit. Click it to make it the active page in the main data window.

6: Form 6 has been defined in the study setup with colored, multi-language backgrounds as well as the default black/white English background for the data entry screen. Select File > Preferences. In the Preferences dialog, change:

Click OK to save the preferences and close the dialog. Confirm that the background CRF in the data window has refreshed to the Dutch version.

Re-select File > Preferences. Change the Background Options choice for CRF Type from Dutch to Spanish. Click OK to apply the preferences and close the dialog.

Re-select File > Preferences. Reset the Background Options for CRF Type to Default. Click OK to save the preferences and close the dialog.

Double-click the entry for 99001. This closes 99004 and opens the list of visits for 99001. Select Subject > Expand All Visits to open all visits and pages for subject 99001. In the record list panel, locate 1: Form 1 under 0 : Screening Visits. Click it to open the page in the main data window.

Select View > Queries to switch to Queries View. Select Show > All Queries to display all queries for the current subject.

Select View > Reasons to switch to Reasons View. Select Show > All Reasons.

Select View > List to switch to List View. Confirm that the Plates & Metadata tab is highlighted at the top of the record list panel. Click 001 - Blood Pressure Screening Visits from the list of plates.

Choose the Modules tab at the top of the list panel to display a list of all modules defined for the study. Click Demographics - Patient Demographics module.

Select View > Batch Edits to switch to Batch Edits View.

Select View > Reports to switch to Reports View. In the reports list panel, double-click DFdiscover Reports followed by Legacy Reports. Highlight the report DF_PTcrfs from the list of Legacy Reports.

In the Specify field, enter the report option -i 99001. Click Run to run the report for subject 99001. Examine the output displayed in the output window.

Select View > Status to switch to Status View.

	Note
	Any pages that have been received and which DFdiscover could not identify as study CRFs will be found in the Image Router. As a result, the number of Images awaiting review in Image Router may differ from what is shown here.

Select View > Dashboard to display the Dashboard View. Click ..., select Record status tabular view and Record status chart. Click OK.

Select View > Schedule to display the Schedule View. Click Refresh to display the scheduling information.

Select File > Exit to exit DFexplore.

Start DFsetup, login as data_manager as described in Section 1.8, “How to start DFsetup”.

In the login dialog, click About. Confirm that the version information in the dialog matches the installed software Version 5.5.X.

Choose 254 Acceptance Test Study, select View Only and click OK to continue. The main DFsetup window opens.

Select Help > Topics to access the documentation. In the documentation window, confirm the documentation version number. Select File > Close to dismiss the documentation window.

Select any plate entry in the Plates-Modules-Fields list panel to make that plate the active plate. The main window is refreshed with the CRF view of the plate definition, which includes widgets for all modules and fields. Click any field widget on the current plate to make that field the active field.

	Note
	DFsetup remembers the last active plate from your previous DFsetup session so your main DFsetup window may display a different plate as the active plate.

Select the 2 - Patient Entry Form entry from the list panel to make plate 2 the active plate. Click Plate View > Field List to replace the Plate view with a listing of all plate 2 fields and their properties. Click Field List > Plate View to return to the Plate view of plate 2.

Select the entry for 6 - Patient Evaluation Report from the list panel to make plate 6 the active plate. Examine the CRF List panel displayed in the bottom-left of the screen. Each entry represents a unique multi-language color background associated with plate 6. This study database has been defined to include colored, multi-language CRF backgrounds for plate 6, with the default background being black/white English. The default English background and some of these multi-language backgrounds were accessed previously in Section 2.5, “Open the Acceptance Test Study and verify the standard DFexplore views.”.

From the CRF List panel, choose the entry 30 Dutch.

Select File > Preferences. In the Preferences dialog, choose Color for Background Color. Click OK to close the Preferences dialog.

From the CRF List panel, choose the entry 30 Spanish.

Return to the default (English) CRF background for plate 6 by choosing DEFAULT in the CRF List panel.

Select View > Sites to open the Sites editor. Review the contents.

Select View > Visit Map to open the Visit Map editor. Visually confirm that the expected contents are displayed. Click Done to close the editor.

Select File > Exit to close DFsetup.

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

Click 3. Study Setup followed by Begin to begin this module.

This module requires user data_manager to have exclusive access to the 254 Acceptance Test Study database, the Control Panel must be closed. Click Exit.

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

Choose Exclusive Access and click OK. Exclusive Access allows you to create and modify plates, styles and fields, and to define all setup configuration files.

Select File > Preferences to open the Preferences dialog. Set:

Click OK to save and close the dialog.

Select Study > Global Settings to open the Global Settings dialog. Click Global tab. Confirm that:

If these options are not set this way, modify them now and click Apply.

Click Help. Select HTML tab. Enter the following:

Click Fields tab, and set:

Click Levels tab. Confirm that the workflow labels of Level 0, Level 1, and through to Level 7 are used.

Click Guides tab. Confirm/change:

Click Custom tab. Confirm that all Property Values are blank.

Click OK to save changes and exit the dialog.

Select View > Styles from the menubar.

	Note
	The style names and information appearing in your Styles dialog may be different from those shown here. You should see the standard DFdiscover Simple styles.

Within the DFsetup-Styles dialog, locate the style name SimpleString. Click SimpleString to select it as the current style. Click Clone to duplicate this style.

Provide a Style name of Comment in the Style dialog and click OK.

Click Comment to make it active, and confirm the Style Properties Basic tab displays the style properties as shown.

Click Detail tab, Change the Store property from 1 to 200. Check (enable) the to the left of the Store property to lock this setting in the Comment style. Click Apply to apply the modifications. Click Done to close the Style Properties dialog.

Choose 10 - Death Report entry from the Plates-Modules-Fields list panel to make plate 10 the active plate. Select View > Modules to open the module definition dialog.

Click Module options New.

Enter a name of Death in the Add Module dialog. Click OK to save.

With the Death module selected as the active module, confirm that the Name Death appears in the Module Properties window. In the Description field, enter Death Report. Click Apply.

Choose Death module defined in Section 3.6, “Create and modify a new module (Death).” to make it the active module. Click Field options New.

To create a field definition for “Cause of Death”, choose Comment from the Style pull-down list, click OK.

Enter the name DEATH for the Field Name: and click OK.

Within the Field Properties, enter a Description of Cause of Death?. Click Apply.

Click Field options New. In the resulting New Field Style dialog, choose S99 NO-YES from the Styles pull-down list. Click OK.

Enter the name AUTOPSY for the Field Name: and click OK.

Within the Field Properties, enter a Description of Was an autopsy performed?. Click Apply.

Click Done.

Still with 10 - Death Report as the active plate, create the field references (layouts) for the Cause of death and autopsy fields defined in Section 3.7, “Assign Field definitions to a newly created module.”. First add the Death module to plate 10-Death Report by clicking Add from the Module options. Locate and choose Death module from the list of modules.

Click OK to add the Death module to plate 10-Death Report.

Click to the left of Death [1] module entry in the Plates-Modules-Fields list to show all field definitions within the Death [1] module.

Create a field reference for the Cause of Death. Using the mouse, select Click the leftmost end of the second longest lines on the plate background. Holding down the left mousebutton and Control, drag up and across to the rightmost end of the line. Release the mousebutton to create a string field widget.

Select the DEATH field in the Plates-Modules-Fields listing to assign a field definition.

Create a field reference for the Was an autopsy performed? field. Using the mouse, click the middle of the No box on the plate background. Next click the middle of the Yes box on the plate background. This defines the position of each response option for the AUTOPSY field.

Select the AUTOPSY field in the Plates-Modules-Fields listing to assign a field definition.

All fields are now defined on plate 10 - Death Report. Select Field > Order. In the dialog, sort the fields as shown, by using the arrow buttons.

Click OK to apply the selected field order.

Click to the left of 10-Death Report in the Plates-Modules-Fields list to collapse all plate 10 - Death Report modules.

Click 11 - Weekly Patient Diary to make it the active plate. Scroll to view all module and field references on the plate.

Click to the left of 11-Weekly Patient Diary to expand the list of modules defined on the current plate. Choose Diary[6] from the list.

Click Copy from the Module options.

Click Paste from the Module options.

In the Paste Module fields dialog specify the substitution shown, which modifies the Alias and Description fields.

Click OK in the Paste Module fields dialog to perform the paste operation.

With the block of fields still highlighted, use the mouse to drag the block of field reference widgets and position them over top of their respective field outlines on the plate background. Click anywhere on the plate background to release the pasted block.

One by one select each Diary[7] field reference widget. Examine the Field Properties window for each and confirm that the Alias and Description properties contain the correct substitution character of 7.

Select View > Query Category Map.

Click Add. The Code field is auto-filled with a value of 30. Press Tab to advance to the Label field. Enter Test for the Label field. Select Yes from the Auto-Resolve drop-down. Set Sort Order to 5.

Click Add. The Code field is auto-filled with a value of 31. Without altering the code number, enter Monitor for the Label field. Select Yes from the Auto-Resolve drop-down. Set Sort Order to 3.

Click Add. Without altering the code number, enter Clinical QC for the Label field. Select No from the Auto-Resolve drop-down. Set Sort Order to 10.

Click Save followed by Done to close the dialog.

Select File > Save [Required] to save all modifications. Click Save in the warning dialog. Select File > Exit to close DFsetup.

To complete the remainder of Module 3. Study Setup, the Control Panel is needed. Start the Control Panel as datafax as described in Module 1 (Installation & Initialization).

Click Send ID 99006 to email a copy of ID99006.pdf to site_monitor. Clicking more than once will result in multiple pages arriving to your email inbox.

	Note
	Save the ID99006.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.

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

Click Add. From the Select PDF Files file selection dialog, locate the previously saved ID99006.pdf file. Select the file and click Open.

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

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

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

Click Show Log to review the DFsend transmission history.

Select File > Exit.

	Note
	Wait 2-3 minutes prior to proceeding to DFexplore.

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

Select View > Image.

Do not change any settings in the Automatic Retrieval dialog, click OK to retrieve the image.

Select Plate > Show Field Properties to display a listing of properties for all fields on the current page. Locate field numbers 46 to 51 that were created in Section 3.10, “Use copy and paste to create repeating module and field references on a plate.”. Verify the settings and click OK.

Upon retrieval of plate 11-Weekly Patient Diary, the cursor is on the Study Week # field. Enter the Study Week # value as it appears on the CRF image. Note that a prefix of 2 is hardcoded in the Study Week # field so that the resulting value will appear as 201. Press Tab to advance to the Patient Number field.

Enter the Patient Number as it appears on the CRF image. Press Tab to move to the Patient Initials field. Enter ANK as per the CRF image and press Tab to advance to the next field.

Starting with the Check this box... field, enter all data for 11-Weekly Diary Report as it appears on the CRF image in the lower half of the split-screen window. Press Tab to move from field to field until field 6. My blood pressure today is the current field. Leave the field blank as per the CRF image and press Tab. The Add Query dialog is presented.

Click Cancel in the Add Query dialog to close the dialog. The 2nd blood pressure field (diastolic) gets the focus. Leave the field blank as per the CRF image and Tab off the field. Again, click Cancel in the resulting Add Query dialog.

Enter the remaining fields on Plate 11-Weekly Patient Diary as per the CRF image. Once a value has been entered in the last VAS field (7. My energy level today), press Tab. This makes the save buttons active at the bottom of the data record.

Note

During document submission, the ICR may fail on one or more of the fields on the Plate 11-Weekly Patient Diary page. You will need to enter values into those fields that have been missed or misread by the ICR. To correct VAS scales, make the desired VAS scale the current field on the data record. Locate the corresponding VAS scale on the CRF image. Using the left mouse button, select the leftmost end of the scale, followed by the intersection point, and then the rightmost end of the scale on the CRF image.

With the focus on the save buttons, click Final to save the record to the database with the status Final.

Select File > Exit to close DFexplore.

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

Click End to confirm successful completion of Module 3. Study Setup.

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

Click 4. eCRF Creation followed by Begin to begin this module.

This module requires user data_manager to have exclusive access to the 254 Acceptance Test Study database. The Control Panel must be closed. Click Exit.

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

Choose Exclusive Access and click OK. Exclusive Access allows you to create and modify plates, styles and fields, and to define all setup configuration files.

	Note
	The main DFsetup window displays the last plate to be active in the user's previous DFsetup session. For this reason, you may see a different plate from what is displayed in the above illustration.

Select Study > Add eCRF Plate. In the Add eCRF Plate dialog enter a New Plate Number of 21. Click OK.

In the Plate Properties set:

Click Apply.

Within Plates-Modules-Fields Module options Click Add. Check Keys, LB, LB1, LB2, LB3 modules, click OK.

Double-click the Keys [1] module to expand the list of fields. Using your mouse, click and drag the SUBJID and PINIT fields onto the 21: Lab Results eCRF.

Click LB [1] Module, drag the module onto the eCRF, select LBORRES_n, LBNRIND and LBCLSIG_c fields by holding Shift and clicking on the fields. Select Field > Group.

Click LB1 [1] Module, drag the module onto the eCRF. Select Field > Group.

Click LB2 [1] Module, drag the module onto the eCRF. Select Field > Group.

Click LB3 [1] Module, drag the module onto the eCRF. Select Field > Group.

Select File > Save [Required].

Select File > Exit to close DFsetup.

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

Click Site 99 - Hospital #99 > Subject 99008 > 1: Baseline > 21: Lab Results to make it the active page.

	Note
	DFexplore stores previously defined user preferences. If site_monitor previously used DFexplore and modified user preferences, you may see a different background than what is illustrated below.

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

Select File > Preferences > Data Window, within eCRF background color, click to open the Select Color window.

Enter HTML:#07458e.

Click OK to close the Select Color window, click OK to apply your color preferences.

Click within the Patient Initials field to display the field level help. Click to close the help dialog.

With subject 99008 21: Lab Results as the current eCRF, click Patient Initials. The initials are pre-filled as a result of the edit check SetInit described in Module 8. Image Data Entry. Set:

Click Final to save the data record.

Select File > Exit to close DFexplore.

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

Click End to confirm successful completion of Module 4. eCRF Creation.

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

Click 5. Custom Properties followed by Begin to begin this module.

This module requires user data_manager to have exclusive access to the 254 Acceptance Test Study database, the Control Panel must be closed. Click Exit.

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

Choose Exclusive Access and click OK. Exclusive Access allows you to create and modify plates, styles and fields, and to define all setup configuration files.

Select Study > Custom Properties.

Click DFSTUDY tab, followed by the empty Tag cell for DFSTUDY_USER1 to make it the active field.

Beginning with DFSTUDY_USER1 cell. Enter the Custom Properties for DFSTUDY as follows:

Click DFPLATE tab, followed by the empty Tag cell for DFPLATE_USER1. Enter the Custom Properties for DFPLATE as follows:

Click DFMODULE tab, followed by the empty Tag cell for DFMODULE_USER1. Enter the Custom Properties for DFMODULE as follows:

Click DFVAR tab, followed by the empty cell for DFVAR_USER1. Enter the Custom Properties for DFVAR as follows:

Click Done to apply the newly defined Custom Property values.

Select Study > Global Settings. Click Custom tab.

In the Custom tab set the following Property Values:

Click OK to save and dismiss the dialog.

Click 1 - Blood Pressure Screening Visits to make it the active page. Within the Plate Properties window click Custom tab.

Enter the Property Value tags as follows:

Click Apply.

Select View > Plates.

Within row 2 Patient Entry Form navigate to the V1 Property Value cell. Enter 1 October 2014. In the V2 cell enter 11 November 2014 - Updated randomization instructions.. Click Apply, Done.

From the Plates-Modules-Fields window double-click 2 - Patient Entry Form. Click Keys [1] to make the module active.

In the Module Properties window specify PTKEYS for the XXTEST Property Value. Click Apply.

Double-click Randomization [1]. In the Module Properties window specify RANDCODE for the XXTEST Property Value. Click Apply.

Select Medication Code # field. Click Custom from the Field Properties window.

Enter [MissingQC] Response is required. in the EC_FLD_EXIT Property Value.

Click Edit checks tab within the Field Properties window.

Enter MissingQC, sdv next to Field Exit, click Apply.

Click Weight (lbs) field, then Custom. Enter [WeightEquiv] Weight conversion. in the EC_FLD_EXIT Property Value. Click Apply.

Select File > Save [Required].

Select File > Export Setup >Excel.

Click Field Properties ....

In the resulting dialog, click Select none.

Select Name, Alias, Description, EC_PLT_ENTER, EC_FLD_ENTER, EC_PLT_EXIT and EC_FLD_EXIT. Click OK.

Specify module5_setup.xlsx as the Output File name, enable (check) Open output file after export.. Click Export.

In the exported Excel file open the Global Settings tab to view the newly defined Global Property tags.

Click 2 - Patient Entry Form to view the newly defined Plate Custom Property tags. Return to DFsetup.

Select File > Exit to close DFsetup.

Start DFexplore, login as data_coordinator and choose 254 Acceptance Test Study as described in Section 1.7, “How to start DFexplore”. Upon logging in a dfmessage edit check dialog is displayed containing the DFsetup-Global Settings Custom property tags defined in Section 5.3, “Defining Custom Properties in DFsetup.”. Click OK to close the dialog.

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

Select Select > Change Mode & Level. Set:

Click OK.

Double-click Site 99 - Hospital #99 > 99010 > 1 : Baseline > 2 : Form 2.

Click anywhere on the page background to make the fields active. Press Tab to advance to the Medication Code # field.

Press Tab to exit the field and execute the sdv edit check.

Click OK to add the edit check containing the Custom Property Value's added in Section 5.3, “Defining Custom Properties in DFsetup.”.

Press Tab to advance through the remainder of the fields on the Patient Entry Form page. Verify that the Save information bar at the bottom of the screen indicates that the saved page will be assigned a record level of 3. Click Incomplete.

Select View > List.

Click 002 - Patient Entry Form.

Select Select > Field Selection to show the listing of all data fields and their metadata properties defined for the plate. In the Data Fields window, click next to fields 7:SUBJID , 10:EXREFID , 12:WTKG , 13:WTLB.

	Note
	Alternatively fields can also be added by dragging-and-dropping the desired fields from the Data Fields or Metadata Fields windows to the Display Fields window.

In the Metadata Fields window, click next to field EC_FLD_EXIT to add the field to the Display Fields window. From the drop-down select 10:EXREFID, click and drag the field to be below the 10:EXREFID - Medication Code # field.

Return to the Metadata Fields window, click next to field EC_FLD_EXIT to add the field to the Display Fields window. From the drop-down select 13:WTLB.

Click Done to apply the field selection criteria and close the dialog.

Select File > Export Data to save the data to a local file. In the dialog, set:

Click ... next to Output File. Choose a directory in the file selection dialog, enter module5_data.xlsx as the filename, and click Save. Click Save to create/write the file and close the dialog.

Select View > Reports.

Double-click DFdiscover Reports > Study Setup > Database Definition.

Click Run.

Select File > Save Output as > Excel.

Click ... next to Output File. Choose a directory in the file selection dialog, enter module5_definitions.xlsx as the filename and click Save. Check (enable) Open output file after export and click Save.

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

Click End to confirm successful completion of Module 5. Custom Properties.

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

Click 6. Subject Alias followed by Begin to begin this module.

Click Send Subject Alias Map to email a copy of subject_alias_map.csv to data_manager. Clicking more than once will result in multiple files arriving to your email inbox.

	Note
	Save the subject_alias_map.csv 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 data_manager to receive the module specific files.

This module requires user data_manager to have exclusive access to the 254 Acceptance Test Study database, the Control Panel must be closed. Click Exit.

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

Choose Exclusive Access and click OK. Exclusive Access allows you to edit the Subject Alias Map.

Select View > Subject Alias Map.

Click Import. From the file selection dialog, locate the previously saved subject_alias_map.csv file.

Select the file, click Open, then Save.

	Note
	Clicking Save triggers the initial import of the Subject Alias Map to be logged in DFsubjectaliasmap.log which leads to the output produced in Section 6.5, “Subject Alias Tracking (Reports).”.

Modify the following Alias definitions:

Click Save then Done to apply the modifications to the Subject Alias Map.

Select File > Exit to close DFsetup.

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

Double-click Site 99 - Hospital #99 to open the list of available subjects.

Select File > Preferences. Check (enable) Use subject alias. Click OK. The Subject ID list now displays the Subject Alias Mapping as defined in DFsetup.

Click Site 99 - Hospital #99 > S254-09-9008 > 1: Baseline > 21: Lab Results to make it the active page.

Select Subject > New Subject. Set:

Click OK.

The message This subject alias does not exist is displayed. Click Cancel to dismiss the New Subject dialog.

	Note
	All Subject Alias definitions are required to be defined within DFsetup. Users are unable to add new Subject Alias definitions within DFexplore.

Double-click S254-09-9012 then entry for 0 : Screening Visits to display the list of pages belonging to the visit. Page 1 : Form 1 becomes the active page. The data window redraws with the plate background and related data entry fields.

Click anywhere on the plate background - this moves the mouse and keyboard focus to the data window.

Beginning at the Patient Number field, press Tab to advance to the Patient Initials. Enter the initials TVM Press Tab to advance to the Age field.

Beginning with the Age field set the following values:

As outstanding required data fields exist on the page it must be saved to the database with a status of Incomplete. Click Incomplete.

Select View > List. Select 001 - Blood Pressure Screening Visits.

Confirm an entry exists for S254-09-9012.

Select View > Reports to switch to Reports View. In the reports list panel, double-click DFdiscover Reports followed by Subject Tracking. Highlight the report Subject Alias Map. Click Run.

Click History of Subject Alias Report then Run.

Select View > List.

Confirm that 001 - Blood Pressure Screening Visits is still the active plate.

Select File > Export Data.

In Export Data dialog set: