Task Descriptions

Item Description

Auto Accept E2B Reports

When the Interchange Service receives incoming ICSRs that are either auto accepted or manually accepted by the user, the AG Service process the reports in background to either create a case for the initial reports or update the case for the follow-up reports. After acceptance, the system moves the reports to ICSR Processed screen and Interchange Service generates an acknowledgment. If ICSR processing is not successful then the report is marked as Failed after the maximum retry attempt has reached.

For details, see Auto Accept E2B Reports Process.

Audit Log Export

Oracle Argus Safety allows the export of Audit Data to a table in a format that is readable by a user.

This process exports up to 2000 cases at a time. After 2000 cases have been exported, the process shuts down and starts again at the next scheduled interval.

Audit Log Update

Oracle Argus Safety allows auditing of data which are updated through database scripts. The Audit Log Update process updates the Audit Log, based on the item stored in the queue.

This process audits up to 500 audits in a row. After 500 Audits have been completed, the process shuts down and starts again at the next scheduled interval.

AutoSignal

Oracle Argus Safety allows the configuration of Signals. Signals can be used to detect events that can be configured using Advanced Conditions. Oracle Argus Safety Service will automatically check for triggered events and notify a selected user of the event.

Batch Report Generation

The Batch Report Generation process eliminates the process of a user having to manually generate a report during a case workflow. Rules can be setup in Oracle Argus Safety to have reports automatically generated on a scheduled basis.

Using this process speeds up the day-to-day tasks for the end user by moving the Report Generation Load to the Oracle Argus Safety Server.

This process executes batch jobs in the ascending order of Due Date of the report (Earliest Due First). It processes 10,000 reports in a day at a minimum.

For details, see Batch Report Generation Process.

Batch Memorized Reports

The Batch Memorized Reports process allows users to have System Reports such as Case Listing Reports and Case Data Analysis Reports automatically-generated, based on a pre-configured report.

Batch Aggregate Reports Generation

The Batch Aggregate Reports process executes the CDA, Case Listing and CIOMS II Line Listing Aggregate Reports in the background thereby reducing the load on the Oracle Argus Safety Web server and avoiding unnecessary user wait time for report generation.

Only standard PDF and CSV output formats use this AG Service. The CDA chart output continues to run in the synchronous mode only.

Batch Periodic Reports

The Batch Periodic Reports process removes the need to remember to schedule, generate and submit IND, NDA and PSUR Reports. Periodic Reports can be automatically scheduled and generated on a schedule configured based on the License Award Date.

Using this process also speeds up day to day tasks for the end user by moving the Report Generation Load to the Oracle Argus Safety Server and off the Oracle Argus Safety Web Server.

This process executes batch jobs in the ascending order of Due Date of the report (Earliest Due First). It processes 10,000 reports in a day at a minimum.

Batch Report Case

Batch Report Case allows users to run reports on a scheduled date.

Bulk Report Print

Prints the reports from a particular enterprise to the printer configured for that site in Oracle Argus Safety Console for that enterprise.

Bulk Report Transmit Email

Oracle Argus Safety supports Bulk Submission of reports for e-mailing. The Bulk Report Transmit Email Process will automatically generate, submit (if the report has been marked for submission) and e-mail reports based on the e-mail address configured for the Report Submission Authority.

Using this process speeds up day-to-day tasks for the end user by moving the Report Generation and Emailing Load to the Oracle Argus Safety Server. Oracle Argus Safety Web requires this to process Emails.

This process e-mails up to 1000 reports in a row. After 1000 e-mails have been sent, the process shuts down and start again at the next scheduled interval.

This process executes batch jobs in the ascending order of Due Date of the report (Earliest Due First). It processes 10,000 reports in a day at a minimum.

Documentum Push

Refer to Oracle Argus Safety Console for storing submitted expedited and periodic reports into Documentum.

Dossier Notification

After a PSUR report is generated and if Oracle Argus Dossier is enabled, this process sends e-mails to all users who are members of groups with assigned roles for periodic reports.

Fax

The Fax Process will automatically transmit fax reports processed by the Bulk Report Transmit Fax Process for Submission.

Fax Status

The Fax Status Process will continuously check for the status of the Fax Submission to update Oracle Argus Safety Information. This process is required to be running if the Bulk Report Transmit Fax Process is enabled.

Forced Report

When forced reporting is configured, this Argus Safety Service sends out forced expedited reports, based on configured reporting rules.

This task has a dependency on the Scheduling Check task, so both must be configured.

General Email

This process sends all the Workflow Routing emails which can be configured within the Workflow Configuration.

It also sends all the Investigator Alert emails which can be configured within the Study Configuration as defined in the Investigator Group configuration.

General Fax

This service is used when a fax service is configured to transmit faxes. It transmits pending faxes in the queue of faxes that are waiting to be sent.

Letter Generation

When letters are configured to be sent based on the case data and configured criteria, this service auto generates letters from cases where the Contact Date has been reached.

Local Labeling Report Scheduling

The Local Labeling Report Scheduling process automatically schedules reports based on the Regulatory Rules configured in Oracle Argus Safety for licenses that are marked as processed from the Local Labeling dialog.

Report Scheduling occurs in the order of the Case Master Follow up Date or the Initial Receipt Date if Follow up is null. This is in ascending order of the Aware Date of the case.

Priority

The Priority Process re-assesses all case priorities based on the Priority rule configuration in Oracle Argus Safety. Using this process prevents cases from being reported on late by escalating the priority of the case which is visible by the users on the Oracle Argus Safety Worklist, Case Form and other areas.

In addition to raising priority, an escalation email will be sent to the supervisor of the group if a case is not routed to the next workflow state within a specified amount of time configured in the Workflow Rules.

Priority Assessment

This process invokes the case priority for initial cases and performs Event Assessment.

Queue Management

This process identifies and creates the records that require Report Scheduling and Scheduling Check. The Queue Management process enables the Report Scheduling and Scheduling Check processes to perform parallel processing of queued records.

Report Scheduling

The Report Scheduling process automatically schedules reports based on Regulatory Rules configured in Oracle Argus Safety for new cases.

Multiple instances of the Report Scheduling process can be configured to process mutually exclusive sets of records in parallel. The number of cases that can be processed by a single instance of the Report Scheduling process is configurable via a global profile switch under Oracle Argus Safety Console > System Management (Common Profile Switches) > Background Services > Number of cases to be processed by single Report Scheduling AG Process.

The default value is 50.

Report Scheduling Check

Oracle Argus Safety allows forecasting of reports that may be due within a specified amount of time for cases that have not been locked and do not have reports scheduled.

Multiple Instances of the Scheduling Check process can be configured to process mutually exclusive sets of records in parallel. The number of cases that can be processed by a single instance of the Scheduling Check process is configurable via a global profile switch under Oracle Argus Safety Console > System Management (Common Profile Switches) > Background Services > Number of cases to be processed by single Scheduling Check AG Process.

The default value is 100.

Note:

When Oracle Argus Safety Service sends an email to the local email client or print job to Adobe Acrobat, it marks the report as Success. If the email client fails to send the email to the Server or the OS fails to print the report to the printer due to network issues or configuration issues outside of Oracle Argus Safety, the status will not be changed to Failed.

It is prudent to add a manual process to confirm that the email client and print queue outside Oracle Argus Safety Service are functioning on an on-going basis.