Generate an Expedited Report

You can generate a report using either of the following procedures.

Method 1: Generating a report

1. Verify that the relevant case has been locked and the required report has been scheduled.
2. Open the selected case to display its associated Case Form.
3. Open the report from the Regulatory Reports tab of the Case Form.
4. When the system opens the Regulatory Reports details for the selected case, locate the relevant report and click the Final link to generate the report.

Method 2: Generating a report

1. Verify that the relevant case has been locked and the required report has been scheduled.
2. Select Case Actions, and then click Open to view the Case Open form.
3. Click Search to view cases matching the search criteria.
4. When the system displays the search results, click the Lock State icon and select Case Details.
5. When the system opens the Argus Safety Case Details dialog box, open the Scheduled Regulatory Reports folder and select the relevant regulatory report.

Note:

• You do not need to lock the case to preview a report in draft mode.
• If you have access rights to view or print blinded information, you are prompted to select whether you would like to view a blinded or unblinded version of the report. If your access rights disallow you from viewing or printing unblinded information, you can view only a blinded version of the expedited report. The following items are not displayed when viewing a blinded version of the expedited report:
  • Clinical Treatment Given (Study Drug field)
  • Study Drug Formulation and Concentration
  • Study Drug Dose, Daily Dose and Route
  • Study Drug Batch/Lot # and Expiration Date
• If the case is locked you can generate the report from the Worklist > Reports, Reports > Bulk Reporting, and Reports > Compliance > Expedited screens.

The Routing tab of the Report Details window displays the date, time, user, and comment details for expedited E2B and paper reports that are manually generated or that are generated by the Argus Service.