Generate an Expedited Report
You can generate a report using either of the following procedures.
Method 1: Generating a report
- Verify that the relevant case has been locked and the required report has been scheduled.
- Open the selected case to display its associated Case Form.
- Open the report from the Regulatory Reports tab of the Case Form.
- 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
- Verify that the relevant case has been locked and the required report has been scheduled.
- Select Case Actions, and then click Open to view the Case Open form.
- Click Search to view cases matching the search criteria.
- When the system displays the search results, click the Lock State icon and select Case Details.
- 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
, andReports > Compliance > Expedited
screens.
Parent topic: Submit your Expedited Reports