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

Click Module 7 followed by Begin to begin this module.

Click Fax ID 99002 to simulate submitting a case report form. Clicking more than once will result in multiple copies arriving in the new image queue. Wait for 2-3 minutes before proceeding.

The following steps require exclusive access to the 254 Acceptance Test Study database. To facilitate exclusive access, close DFATK by clicking Exit.

Start DFsetup.

Complete the login dialog with the correct value for DFdiscover Server in your environment. Enter datafax in Username and the matching account password in Password.

Click Login.

Select the 254 Acceptance Test Study then click OK to open its database.

Choose Developer Access in the Access mode dialog, click OK.

The main window for DFsetup is displayed. Select Study > Global Settings.

Click Global tab in the Global Settings dialog.

Check (enable) if not already checked Allow multiple queries per field.

The warning message: This CANNOT be undone once the Study Setup is saved is displayed.

Click OK to close the Global Settings dialog.

Select File > Save [Required], followed by File > Exit.

Start DFexplore.

Complete the login dialog with the correct value for DFdiscover Server in your environment. Enter valid1 in Username and the matching account password in Password.

Highlight the entry for 254 Acceptance Test Study. Click OK to continue.

The main window for DFexplore is displayed. Select View > Image.

In the Automatic Retrieval dialog, set:

Confirm the settings.

Click OK.

The first image retrieved is the Adverse Event Report CRF.

The Adverse Event Report No. field is highlighted as the current field. Enter the value from the CRF image if it is not already correctly auto-filled. Press Tab to advance to the AE Identifier field. The AESEQNUM2 edit check executes upon entry to the AE Identifier field. The data value in the field is updated.

Press Tab to advance to the Patient Number field.

Beginning at the Patient Number field, correctly enter the data per the CRF image, up to and including the Intensity field. Tabbing from the Intensity field, a user-defined edit check executes and the dfaddqc: Severity dialog is displayed.

Click OK to apply the edit check. The field becomes blue, and the next field Relationship to Study Drug becomes the current field.

Correctly enter each data field on the page per the CRF image, up to and including the Description field.

Do not enter any text in the Description field as the corresponding field on the CRF image is blank. Upon tabbing off this field, the dfaddqc: MissingQC dialog appears.

Confirm that Missing is displayed in the Query category field.

Click OK. This applies the edit check to the Description field. The field becomes blue, and the AECOTERM becomes the current field.

From the AECOTERM field, press Tab through all remaining fields until the Investigator's Signature field becomes the current field.

Tabbing from the Investigator's Signature field, the DFlookup: investigators dialog appears. Highlight Dr. John Snow and click OK.

Enter the Date field value. Press Tab to advance to the save status bar to make it active. Click Incomplete.

With the Adverse Event Report displayed as the current page, make the page active by clicking anywhere on the page background using the mouse. Press Tab to advance through the fields until Description becomes the current field. Note that the Description field is blank and has an unresolved query with the category Missing (external, correction). Enter the text Nausea, ??? and fever.

Select Field > Add Query or click . In the dialog, confirm Category type Missing is disabled. Set:

	Note
	Multiple queries can be added to a single field, but each query must have a unique Query Category type. Therefore, a Query category will be disabled if it has been previously used on the same field where a new query is to be added.

Click OK to apply the query. Confirm that the Description field is the current field with the query count '2' displaying on the top left corner of the field widget, and the field becomes blue.

With the focus still on the Description field, examine the details in the Query window that appears at the bottom left corner of the main data entry screen.

Select Field > Add Query or click to add the third query to the Description field. In the dialog, set:

Click OK to apply the query. Confirm that the Description field is the current field with the query count 3 displaying on the top left corner of the field widget, and the field becomes blue.

With the focus still on the Description field, examine the details in the Query window that appears at the bottom left corner of the main data entry screen.

	Note
	The query list is presented in accordance with the query sort order that has been defined by the user in DFsetup Query Category Map.

Press Tab to exit the Description field, and a DFlookup: aecodes window appears. Click Cancel in the window to close the dialog. The next field AECOTERM becomes the current field.

Press Tab to advance through the remaining fields on the page without making any changes. Press Tab to advance to the save buttons at the bottom of the data screen to make them active. Click Incomplete.

With the Adverse Event Report page still being the active page, select View > Queries to open the Queries View window. In the resulting confirmation dialog, click OK to release all Image records. Select Show > All Queries. Double-click Site 99 - Hospital #99. Locate and confirm that the Queries window displays the three queries that have been applied to the AE Description field for Subject 99002.

Select Show > Outstanding Queries. Locate and confirm that two unresolved queries with categories Other and Monitor on the AE Description field of Subject 99002 are displayed.

Double-click entry containing the query category Other in the Description field of Subject 99002, Adverse Event 1 Page 1: Form 9, AE Report 011.

Select Select > Change Mode & Level. In the dialog, set:

Click OK to apply the changes.

Delete the text ??? in the description field and enter vomiting instead. Examine the query window. From the Query drop-down choose Other (external, correction) query in the query list.

With the focus on the Other (external, correction) query Description field, select Field > Edit Query, or click the to open the dialog. set:

Click OK to apply the edits.

Select Monitor (external correction) from the Query pull-down to make the query active.

Select Field > Reply to Query or to open the dialog. Enter Fever will be removed to a different Adverse Event Report form. in the New Reply field.

Click OK to close the dialog. Examine the information present in the Query window.

Choose Missing (external, correction) from the Query pull-down list. The query list in the query window displays the Missing (external, correction) query. Confirm that the first query is defined with Category: Missing (external, correction) and a Status: Resolved corrected.

Select Field > Delete Query or click to open the Delete Query window.

Click OK to perform the query deletion.

Click Delete in the Delete Query confirmation dialog. Confirm that the Description field remains as the active field and has the query count 2 displaying on the top left corner of the field widget.

Press Tab to exit the Description field, and a DFlookup: aecodes window appears. Click Cancel in the window to close the dialog. The next field AECOTERM becomes the current field.

Press Tab to advance through the remaining fields on the Adverse Event Report page until the Incomplete at the bottom of the screen becomes active. Click Incomplete to save the modified page to the database.

Select File > Exit to close and exit DFexplore.

Start DFATK.

Click End to confirm successful completion of Module 7.