Use the Oracle Argus Unblinding Report Viewer

Use the Oracle Argus Unblinding Report Viewer to select and view unblinded reports.

The following table describes Oracle Argus Unblinding Report Viewer fields and controls:

Field/Control	Description
View	Opens the report in Microsoft Word.
Print	Prints the report to the printer.
Close	Closes the current window.

Use the following procedure to use the Oracle Argus Unblinding Report Viewer:

1. Select Start > Programs > Oracle > End of Study Unblinding > End of Study Unblinding.
2. When the log in window opens:
   1. Enter the user name in the User Name field.
   2. Enter the user password in the Password field.
   3. Enter the name of the database where Oracle Argus Safety is installed in the Database field.
   4. Click Login.
3. When the Oracle Argus Unblinding application opens, choose Argus Unblinding> Report Viewer.
4. When the Report Viewer dialog box opens:
   1. Select a report to view from the list at the bottom of the dialog box.
   2. Click View… to view the report in Microsoft Word.

Oracle Argus Unblinding Updates

Oracle Argus Unblinding does not pick up a case that is globally or locally unlocked. These cases are logged in the exception report as today but with the failure reason modified to say

Case is unlocked (globally and/or locally) or open

The unblinded report includes these cases under one of the following three corresponding sections retaining the existing functionality:

• Not Locked and Not Closed Blinded Suspected cases
• Not Locked and Not Closed Blinded Not-Suspected cases
• Not Locked and Not Closed Cases Un-blinded (during study) cases

Oracle Argus Unblinding does not pick up a case that is pending local or global report submission. Oracle Argus Unblinding used to abort when a report was pending submission. This has been fixed to skip the case when pending submission and log in the exception report with the failure reason

Case is pending report submission

The unblinded report includes these cases under one of the following three new sections:

• Pending Report Submission Blinded Suspected cases
• Pending Report Submission Blinded Not-Suspected cases
• Pending Report Submission Cases Un-blinded (during study) cases

Once unblinding is complete for a Local PRPT Case, the system shall continue to perform global lock as with existing functionality but shall not perform any local lock and hence shall not generate any local reports. It is expected that the customer shall manually local lock the case after local data entry, license selections and assessments.

Note:

The system shall determine the local reports based on the Local Reports Configuration and the reporting rules that were selected in the Oracle Argus Unblinding configuration.

These cases shall also be not be picked by Batch Case Closing Module.

The unblinded report shall include these Local PRPT Case that had been unblinded but not been locally locked by the system after unblinding, under the following new section. Note that a case may appear in only one of the sections in the unblinded report. So a case listed under this new section shall not appear under the existing "Suspected Cases which were Un-blinded following the study end" section (or any other section).

Batch Case Closing Module shall retain the existing functionality and shall check both local and global reports if they are pending generation to determine if a case can be closed.