New Expedited Report Dialog Fields

The Schedule New Expedited Report window has a drop-down list on the top section.

The following table lists and describes the fields in the New Expedited Report dialog box.

Item	Function
Product	Select the Company Suspect Product from this drop-down list.
License Number	Select the particular license for which the report is to be scheduled.
Destination	Select the Regulatory Agency to which the report is to be sent.
Report Form	Select the Report Form from this drop down list.
Message Type	Select the message type from the drop-down list, as configured in Oracle Argus Safety Console. Note: This field is displayed when an E2B report is selected as the Report Form.
Aware Date	List the date when you became aware of the case. Select the Protect Confidentiality of Reporter and Patient checkbox if you do not wish to disclose the identity of the reporter and the patient of the case.
Group	If you want to assign the report to a specific group, the group can be selected from this drop down list.
Notes	This field is directly mapped to the License but you can modify this field to put in extra notes, as desired.
Cover Letter	You can attach a cover letter with the report, if desired.
Due Date	You can decide to schedule a report to be due in either 5, 15, or 30 days or any number of days or even on any specific date.
New Report	Select this option to schedule a new report.
Non-Reportable Follow-up Report	Select this option to schedule a downgrade report.

Note:

Product, License Number, Destination, Report Form (E2B), and Due Date must be entered in the New Expedited Report dialog to schedule an E2B report.

The system allows you to generate E2B reports through AG Service irrespective of the your access rights for blinded information. However, the Blind protected users are not allowed to view E2B reports despite having an Oracle Argus Interchange license. If such a user tries to view the E2B report, the system generates the message: Report is generated but system is unable to show the report as user is protected from study information.