6 Manage your Expedited Report submissions

Schedule a report manually

1. Open the case for which the report has to be scheduled.

2. When the system displays the Case Form for the selected case, select Regulatory Reports, and then select Schedule New Reports.

3. When the system opens the Schedule New Expedited Report dialog box, enter the appropriate information in the fields in the dialog box:

   Field	Description
   Aware Date	If an Aware Date is appended with '(A)' in the drop-down list, it is used to denote the aware date of an Amendment. The resulting expedited report Due Date is based on the selected Aware Date and the duration of the Due Date section. The selected Aware Date has no impact on the Actual Due Date if the user specifies an absolute Due Date. For instance, selecting a date in the Due Date field causes the report to be due on the specified date, regardless of the selected Aware Date. This drop-down list is only populated and enabled after a license has been selected. The Aware Dates are displayed in descending order of the Current Aware Date.
   Protect Confidentiality of Patient and Reporter	Check this checkbox if identifying information about the patient and the reporter must not appear on the report. The system also displays 'MSK' null flavor in the eVAERS report when this checkbox is checked. MSK is populated only when the data element contains some data and is not null.

   
   

4. Click OK.

To view all scheduled reports, go to Reports, then select Compliance, and click Expedited. Alternatively, you can go to Worklist, and select Reports.

Auto-schedule a report

1. Open the case for which the report has to be scheduled.

2. Select Regulatory Reports, then select Auto Schedule or Auto Schedule Device.

Reports will be scheduled against the reporting rules which have been set up by the administrators.

Create unscheduled expedited reports

1. Select Reports, then select Compliance, and select Expedited.

2. Click Batch Print or Create Report and search for the case for which the expedited report has to be scheduled.

3. When the system displays the search results, select the locked cases for which the expedited report is to be scheduled.

4. Click Batch.

5. When the system opens the Batch Print or Create Reports dialog box, enter the appropriate information and click OK.

The system generates the unscheduled expedited report.

Batch print or create reports

You can use the Batch Reports function to schedule and generate reports for multiple cases. Before using this function, verify that no cases or reports are open.

1. Select Expedited Reports from the Reports - Compliance menu.

2. When the system opens the Expedited Reports dialog box, click Batch Print or Create Report.

   Field	Description
   Suspect Product	Displays the Trade Name for which the report has been scheduled. A (+) displayed at the end of the Product Name denotes that more than one Suspect Company Product exists. For Reports which were scheduled for the Device, the Device name gets displayed.

   
   

3. When the system opens the Expedited Reports dialog box, search for the cases for which the expedited report needs to be scheduled.

4. When the system displays the search results, select the appropriate cases and click Batch.

5. When the system opens the Batch Print or Create Reports dialog box, enter the appropriate information in the fields and click OK

The Expedited Batch Printing dialog box supports printing Batch CIOMS, Medwatch, and VAERS on Argus Web locally.

Batch Print or Create Reports dialog box—Fields and Field Descriptions

Review a draft Expedited Report

1. Open the case for which you want to view a draft report.

2. Click the Regulatory Reports tab.

3. From the Total Number of Rows tab, locate the relevant report and click Draft to view the report.

4. Alternatively, click the Draft Report icon on the top right of the screen and select the required draft report.

Review your scheduled reports

The Regulatory Reports tab enables you to view all scheduled reports.

When a new case is created, there are no reports associated with it. As data is entered and the case is saved, the regulatory report scheduling algorithm determines which reports, if any, are required for that case.

The reports determined to be necessary appear in the Regulatory Reports tab. You can manually schedule reports through the Reports menu or by clicking the Regulatory Reports tab. You can also add comments to existing reports. The comment section can be updated to enter notes for a report even after it has been submitted.

• The case submission date must be on or after the initial receipt date for the case. If the submission date is before the initial receipt date, the system displays an error message.

• The system displays the time component for the date generated on the Case Form > Regulatory Reports tab using the IE offset of the client machine for the display.

• The system displays the time component for the date generated on the Report Details using the IE offset of the client machine for the display.

• When you manually schedule an Expedited report, the system places the word, Manual, in the Notes field along with the current notes information.

View Expedited Report status

1. To review the status of expedited reports, select Dashboards, and then select Expedited Report Status.

2. In the Search Case section, enter the parameters, and click Retrieve.

3. To view a list of cases, click the relevant section of the pie chart or bar chart.

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.

Approve your report

1. Open the case associated with the report that needs to be approved.

2. When the system opens the Case Form, click the Regulatory Reports tab to displays the case details.

3. Click the icon associated with the report you wish to approve and select View Report Details.

4. When the system opens the Report Details dialog box, click the Routing tab.

5. When the system opens the Routing tab, select Approved from the State drop-down list and click Route.

6. When the system opens a dialog box, enter the required information and click OK to approve the report.

Transmit an ICSR

To transmit reports one by one, select Reports Detail Dialog, and click the Transmit tab.

• Go to Case Actions, then click Open, and select Regulatory Reports. Left-click on the Status icon, and select Transmit.

• Go to Report, then select Compliance, and select Expedited. Left-click on the globe icon to show the report details, and select Transmit.

The Transmit tab enables you to transmit a case electronically.

1. Select the recipient from the Available Recipients list.

2. Select the transmission method from the Method list.

3. Enter any comments under Comments.

4. Click Transmit.

Transmit several ICSRs at once

To transmit several reports at a time, go to Reports and select Bulk Reporting, then select Print Regulatory Report and click Transmit. Select the cases you wish to transmit, and click Transmit at the bottom of the screen.

The Bulk Transmit function lists the status for all transmission events against your assigned cases.

To view the Bulk Transmit page, hover over the Worklist menu and select Bulk Transmit.

Print your reports

The Bulk Print function displays a separate list for all Bulk Print events against reports.

1. Hover over the Worklist menu and select Bulk Print.

2. When the system opens the Bulk Print page, enter the appropriate information.

Store Expedited Reports in Documentum

Argus Safety lets you store your Expedited Reports in Documentum.

• Mark an Expedited Report as submitted from within Argus to insert the report into the Documentum system as a PDF.

• If the report is to be transmitted via fax or email, Argus Safety Service marks the report as a successful submission in Documentum only after the fax or email transmission has succeeded.

Track ICSR outgoing status

1. To monitor the Outgoing messages and Acknowledgements, go to Utilities, then select ICSR, and click ICSR ICSR Transmit Status.

2. In the Search Reports section, enter the search criteria, and click Search.

   The search results appear in the Total Number of Rows section.

   If the Agency is selected as Any, the search results display all ICSR messages and acknowledgements for all receivers.

View ICSR transmit status

The Bulk ICSR Transmit function displays only those ICSR Reports that are awaiting submission (not in submitted state) when transmitted from Bulk Report By Form to the Trading partner.

1. Hover over the Worklist menu and select Bulk ICSR Transmit.

   The Bulk ICSR Transmit page appears with following tabs:

   • Reports—Displays the status of individual ICSR Reports that are in the process of being transmitted.

   • Messages—Displays the status of ESM Messages which may contain multiple reports.

2. Once reports have been successfully submitted and marked as submitted, they no longer show when you go to Worklist and select Bulk Transmit, when you go to Worklist and select Bulk Print, or when you go to Worklist and select Bulk ICSR transmit. To find a list of all successfully submitted cases, go to Reports, then select Compliance, and click Submitted.

3. Alternatively, go to Utilities, then select ICSR, and click ICSR Transmit Status.

Track incoming ICSR reports

Manage pending reports

When using ICSR Pending reports, right-click the row and select the following:

• Case Summary

• Medical Summary

• Case Form Print

Track bulk incoming ICSR reports

The Bulk Incoming ICR Reports enable you to import multiple ICSR reports that are sent by the agency or trading partner. To view the Bulk Incoming Reports:

1. Select multiple reports from the Incoming ICSR Reports screen.

2. Click Accept ICSRs.

Note that:

• The reports that are imported can be a combination of Initial, Follow-up and Nullification reports.

• The only pre-requisite for this dialog box is that Case numbering should be set to auto-numbering and not manually.

• Bulk Incoming Reports does not prevent the duplicate cases to be loaded into the system.

The following table lists Bulk Incoming Reports fields.

Search for duplicate reports

The Duplicate Search dialog box for an ICSR report enables you to search for possible duplicate cases in the Argus Safety system. You can select different combinations of search criteria. When more than one criterion is selected, only cases that satisfy all criteria are listed. By default, the fields that are present in the ICSR Report are checked for the Duplicate Search.

View processed ICSR reports

The Processed ICSR Reports page contains a list of ICSR that are processed successfully or processed with Errors/Warnings.

Track ICSR incoming status

To monitor incoming ICSR:

1. From Utilities, go to ICSR, and select ICSR Receive Status.

2. In the Search Reports section, enter the search criteria, and click Search.

   The search results appear in the Total Number of Rows section.

   If the Agency is selected as Any, the search results display all ICSR messages and acknowledgements for all receivers.

3. Click the Type Icon link to view message options.

View message options

• Click the Type icon to view the options:

  • Any—Displays all the ICSR messages and acknowledgments.

  • MSG—Double-click MSG to view messages in the ICSR Viewer.

  • ACK—Double-click ACK to view the acknowledgement.

When you click any above-mentioned option, the Message Acknowledgement screen appears.

This screen contains all the safety report detail information such as, if the report is loaded or not loaded with error and enables you to monitor message acknowledgements.

Find overdue reports

1. On the Home page, hover over the Worklist menu and click Reports.

2. Click on the field Days Past Due on the right of the Total Number of Rows and if needed click again to show Days Past Due in descending order (arrow pointing downwards).

   
   

3. To view all reports select ALL at top right of the screen.

For details on entering data in each section of the Total Number of Rows tab, see Total Number of Rows link.

What is a scheduled report?

A scheduled report allows the system to calculate a report based on the date received, seriousness criteria, and reporting rule configuration if any. You can schedule any report. The case data within the reports continues to be updated as the case is updated.

What is a generated report?

A generated report creates a draft report for review. The case needs to be locked for the system to generate a report.

What happens when a report is approved?

Approving the report allows the User to sign off the report.

What is the difference between submitting and transmitting a report?

A report can be submitted to a regulatory authority either by printing it off and marking it as submitted, or sending it electronically from within Argus via fax, email or E2B. Transmission is the electronic form of submitting a report.

What happens when manually scheduling a Local Japan report?

On Manual Scheduling of a report by a user, the application identifies if the report is a Local Japan report by matching the Country of the License#, Destination and Report Form chosen by the user in the "Schedule New Report" manual report scheduling dialog box with the "Local Reports Configuration".

If DLP is not enabled for Expedited Report Generation:

1. On the Global lock of a case by a user, the application generates the global reports but does not generate any Local Japan reports.

2. The Local Japan reports shall be generated on subsequent local lock for Japan.

If DLP is enabled for Expedited Report Generation, refer to the chapter in Oracle Argus Safety Japanese User's Guide > 4 Reports.

For a Study-based WHO Drug Report, the application identifies if the report is a Local Japan report by matching only the Destination and Report Form chosen by the user.

For a Study-based WHO Drug Report, the application identifies if the report is a Local Japan report by ignoring the country, matching only the Destination and Report Form chosen by the user and if the Truly Local Case switch returns value > 0.

Note that if AUTO_FOLLOWUP_MANUAL switch is ON, the existing functionality of scheduling a follow-up report for a manual report is retained as is and if the manual report was a local report, the follow-up is treated as a local report.

What happens when auto-scheduling a Local Japan report?

On the Global lock of a case by a user, the application triggers the qualifying reporting rules including the Japan reporting rules and schedule the relevant global and local reports. There are modifications to the Report Generation functionality however, and is explained under section Changes to Report Generation.

On the Local Lock of a case by a user, the Local Reporting Rules for Japan are triggered again as follows, depending on the value in the configuration switch "Case Form Configuration | Auto Regulatory Scheduling":

• If the value is set to Always: The Local Japan reporting rules are triggered on case save during the follow-up cycles of case processing when any of the local fields caused the "Significant" data change. If any of the other fields caused the "Significant" data change, then all the reporting rules are triggered as with the existing algorithm. Also, for the initial case cycle, only local reporting rules are triggered on Local lock.

• If the value is set to Significant: The Local Japan reporting rules are triggered on Local Lock but respecting the existing algorithm to check that Significant Follow-up was added during the prior global lock cycle during the follow-up cycles. For the initial case cycle, as with the existing algorithm, they trigger on Local lock.

• If the value is set to any value other than None, including Manual: A new checkbox called Schedule Local Reports Only will be added under the Total Number of Rows section in the Regulatory Reports tab of the Case Form. This checkbox is visible only when the configuration switch Case Form Configuration > Auto Regulatory Scheduling is not set to None. After the rules are successfully triggered, the application unchecks the checkbox. If the checkbox is unchecked, the application triggers all the qualifying reporting rules keeping the current functionality.

Force Distribution: If force distribute is checked for a reporting rule, the application triggers that reporting rule as per the existing functionality. However, the generation and force distribution of the Local Reports have the following modifications:

a. When a Local reporting rule marked for "Force Distribute" has a local report that has become due, the report is scheduled, generated and force distributed by performing the global and local lock on the case using the existing AG Service Force Reporting process.

i.When a Local report that was already scheduled outside of the force distribution process from a local reporting rule marked for "Force Distribute" has become due, the application does not force generate this report keeping it consistent with the existing functionality.

b. For the above scenario, AG Service uses the one step global/local lock comment "Case Globally and Locally locked for JP." (refer section Routing Comments Log and Case Print) followed by the configured comments under Argus Console ' Reporting ' Expedited screen' Forced Distribution comments.

i. Case Globally and Locally locked for JP. << Forced Distribution comments>>

c. After the report generation is complete, the case gets unlocked globally. AG Service uses the one step global/local unlock comment "Case Globally and Locally unlocked for JP." (refer section Routing Comments Log and Case Print) followed by the configured comments under Argus Console ' Reporting ' Expedited screen' Forced Distribution comments.

i. Case Globally and Locally unlocked for JP. << Forced Distribution comments>>

What components are affected by the expedited reporting rules algorithm?

The expedited reporting rules algorithm affects the following:

• Suppression of duplicate reports

• Blinded/forced distribution

When are follow-up reports created?

Follow-up reports are created depending on the following parameters:

• Data for a case changes.

• Update information for a case has been entered by entering follow-up information in the General Information section of the General tab.

• Depending on the configuration set up by the Administrator, the system analyzes the scheduled reports prior to the data changes to see if they are still required.

• If the system determines that they are not required, the report status is marked as Downgrade. New reports are automatically scheduled, if required.

• If the system determines the report is still needed and needs to be updated, one of two functions can take place depending on the configuration done by the Administrator:

  • The system overwrites the report

  • The system schedules a new report in addition to the old report

• If the system has been configured to overwrite the existing report, the report status becomes New Data Available.

• In the Worklist, the status for this report shows New Data Available for this report. When you re-generate the report, you can select whether or not you would like to re-generate the report with the new data.

• If the system is configured to create a Follow-up report, the previous report remains in its current state and a new report is scheduled with the status of Scheduled.

• If a report has been previously submitted, this report is never deleted under any configuration.

Why can't I view a draft report?

You can only view a Draft report if the relevant case is unlocked.

Why doesn't my draft report print a follow-up number?

The following expedited report forms do not print a Follow-up number when the user selects DRAFT on the Regulatory Reports tab or when he/she selects the Quick Launch Draft option:

• US FDA MedWatch Drug/Device

• US FDA VAERS

• CIOMS I/CIOMS I (Local)

• French CERFA

• Spanish Spontaneous/Clinical

How does the Lock State Column under Reports > Compliance > Expedited allow me to sort my cases?

Click the Lock State header row to sort on the following category of cases. A pop-up window appears, with the following sorting options:

• Lock State

• SUSAR

• Exp/Per

Click the required option to sort cases based on the selected case categorization.

Lock icons

Icon...	Identifies...
	A case marked for a Periodic ICSR submission.
	A locked case.
	An unlocked case
	A SUSAR (Suspected Unexpected Serious Adverse Reaction) case.

Lock icon options

How do I view the status of my Expedited Report?

How do I know if an unscheduled report is due soon or needs to be submitted?

As report scheduling is commonly configured to be executed when significant changes are made to a case, the expedited reports may be delayed if a case never gets locked. You cannot know that a report is late if it has never been scheduled. To address this potential compliance issue Argus Safety assesses case reportability prior to formal report scheduling. Workflow and Expedited Status monitoring screens identify unlocked cases due soon.

• To view a list of unlocked cases with reports due, select Dashboards, and then click Reports Due Soon.

  The Unlocked Cases with Possible Reports Due Soon screen appears.

• The Workflow and Expedited status include another report with cases that have not had reports scheduled but that may generate a report with a due date in the near future. This graph is displayed below the graph detailing the actual case status. The reports included in this sub-dashboard are limited to the filter criteria specified for the main dashboard.

  To view a Worklist with cases of the selected state (red or yellow), click the graphical bar.

Where can I view single reports which have been generated as part of a periodic report?

The Periodic folder contains single case report forms (MedWatch, VAERS or CIOMS) that were generated as part of a Periodic Report.

• Pending Reports by Destination

• Submitted Reports by Destination

• Non-submitted Reports by Destination