Last updated on SEPTEMBER 05, 2017
Applies to:Oracle Argus Safety - Version 8.0 and later
Information in this document applies to any platform.
1. After a report scheduled, it can be generated when clicking the ‘Final’ button in Regulatory Reports tab. How to configure the system so that the report can be generated automatically without clicking Final button?
2. Argus Console > System Configuration > Report Generation > create as follow-up: it means if a significant follow-up row is added, there will be a new report named ‘F/U xxx’ generated to reflect the follow-up information. However, after testing it was found the previously generated initial report was updated as well with the new information. Does it make sense?
3. About sending report to the destination via email: after generation/approve, the report will appear in Reports > Bulk Reporting. When we transmit a report in Reports > Bulk Reporting, what’s the flow of the report? In other words, will the report be sent directly to the destination using destination’s email and SMTP set in Code List > Reporting Destination? Or will the report be sent to our company’s (FMD) mailbox, and then our company send it to the appropriate destination? Argus Console > Business Configuration > Expedited Reporting Rules
1. Could you specify the details of Super Rule? Is it a default definition and doesn’t need configuration by us? And when shall we select this checkbox?
2. About the downgrade report. For example, as per the initial report, the causality is related; but upon receipt of follow-up information, it’s found unrelated. Then a downgrade report should be generated and submitted to the previous reporting destination, correct? Then how should we configure the reporting rule for such downgrade report? Or does the
system identify automatically that the report is a downgrade report?
3. When shall we use Reporting Category and License Category? Argus Console > Business Configuration > Products and Licenses
1. The License # entered here will display in the Event Assessment subtab with a hyperlink. And when clicking the hyperlink, a dialog box appears as following screenshot. Then how should we configure the Reference for the license? Argus Console > Business Configuration > Study Configuration 1. Clicking ‘Add’ button in ‘Study Reporting’ section triggers the dialog box as following screenshot. But the product is a company drug but not a WHO Drug. Why would it happen? Argus Console > Code list
1. “Electronic Transmission Recipient”: what recipient does this item refer to? What’s the difference between ‘Electronic Transmission Recipient’ and ‘Reporting Destination’?
2. Reporting Destination > SMTP: If SMTP is edited and saved, does it mean the report will be sent to the destination via email automatically using emails entered? Then at what time will the email be sent out (whether related to the submission process in regulatory report tab and bulk reporting?)? And whether the email content will be the report generated in regulatory report tab?
Argus Console > System Configuration > Field Validation
1. For example, if we want a warning appearing when the event onset date is earlier than the drug start date entered. But we couldn’t compare the values in these two fields directly in Advanced Conditions. Then is it possible to setup such field validation? Argus Console > System Configuration > Case Priority
1. The priority was tested as follows: if case is serious and reportable, it will be assigned as Priority
1. However, no priority was assigned to the existed cases and new created cases. Could you specify the problems during the configuration?
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