6 Reports: Compliance and Aggregate Reports

6.1.1.1.1 Storing 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.

6.1.1.1.2 Understanding Follow-up Reports

Follow-up reports are created when significant follow-up information is entered for the case. This is indicated by entering follow-up information in the General Information section of the General tab and when one of the following happens:

• Data for a case changes

• Update information for a case has been entered

• 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.

6.1.1.1.3 Viewing a Summary of Expedited Regulatory Reports

6.1.1.1.4 User Options

Several common features are available in the Expedited Reports section.

Lock State Header Options

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—Descriptions

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—Field Descriptions

6.1.1.1.5 Scheduling Reports

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 -> 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.

4. Click OK to schedule the report.

5. Save the case to save the report.

Schedule New Expedited Reports dialog box—Fields and Field Descriptions

Auto-scheduling Reports

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

2. Select Regulatory Reports > Auto Schedule or Auto Schedule Device.

3. Reports that qualify as per Reporting Rules defined in Console are populated.

4. If the checkbox, Suppress Auto-scheduling is marked for an Agency in the Reporting Destination codelist, the system does not schedule reports (Initial, Follow-up, Amendment, Nullification) for that Agency during Auto-scheduling (via AG services, Clicking on Auto-scheduling, Auto-scheduling of f/p reports for a manually submitted report). However, reports can be manually scheduled to the Agency that is set for Suppress Auto-scheduling.

Follow-up scheduling for eVAERS

If the case was previously submitted to a Reporting Destination as VAERS report to an Agency and if the reporting destination configured earlier with VAERS is changed to eVAERS report, then:

• The system schedules the next eVAERS as a Follow-up report to VAERS instead of scheduling (auto or manual) as Initial eVAERS if Case has received follow-up information.

• If the case has amendment as follow-up data, then:

  • Type of report is displayed as Initial(A1) if the last report submitted to Agency was Initial report (in VAERS)

  • Type of report is populated as F/U# <Number>(A1) if the last report submitted to Agency was a follow-up report (in VAERS)

• The follow-up numbering displayed in the Case Form -> Regulatory Reports Seq field is incremented from the previously submitted VAERS report. If the follow-up of the case is an amendment, the follow-up numbering uses the Amendment number.

If the case with previously submitted VAERS report is deleted and then if the transition happens from VAERS to eVAERS, customers may use the existing practice to indicate the nullification of the previously submitted VAERS report.

6.1.1.1.6 Generating Reports

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.

5. The system generates the selected 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 -> 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.

6. The system automatically generates the report.

6.1.1.1.7 Approving Reports

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.

   Refer to Report Routing to understand how you can route a report to another state.

6.1.1.1.8 Creating Unscheduled Expedited Reports

1. Select Reports -> Expedited -> Compliance.

   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.
   F / LT	Denotes Fatal / Life Threatening If the case is both F and LT, only F is displayed. If the case is neither F nor LT, No is displayed.
   7/15	Displays 7 if the report is due within 7 days Displays 15 if the report is due in more than 7 days

   
   

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.

6. The system generates the unscheduled expedited report.

Batch Print or Create Reports—Fields and Field Descriptions

6.1.1.1.10 Expedited Reporting Rules Algorithm

The expedited reporting rules algorithm affects the following:

• Suppression of Duplicate Reports

• Blinded/Forced Distribution

• Letter Placeholder for the IND Cover Letter

Suppression of Duplicate Reports

You can suppress duplicate expedited reports to be scheduled at the reporting destination level, according to the following criteria:

• The Suppress Duplicate Reports option only applies to drug reports. It does not apply to device reports.

• This option does not reduce the number of reporting rules the system evaluates. However, it does prevent the system from scheduling and generating expedited reports that match the duplication criteria.

• When you select Suppress Duplicate Reports, the system uses the following attributes to determine whether the reports are duplicates of other reports:

  • Report Form

  • Reporting Destination

  • Aware Date

• If two or more duplicate reports have different due dates (regardless of license type), the system schedules the report with the earliest due date.

Blinded/Forced Distribution

The system enables you to configure the Blinding Study option for products in the case.

• When you check this checkbox, the system blinds the study products for the report being sent to the reporting destination in a manner similar to the Bulk Reporting dialog box option.

• If you select either of the Blind Study product options (Reporting Rules or Bulk Reporting), the system blinds the study product information on the report form.

• The system blinds only active blinded studies. It does not blind the following case reports even if the Blind Study product is selected

  • Open Label Studies

  • Study is eligible for unblinding - If the Study is Unblinding checkbox is not kept as unchecked in study configuration, the user will be able to see the complete case data even if he/she has protection enabled.

• In cases where expedited reports are due, the system permits the user to force-distribute the reports based on user-defined reporting rules, even if case processing is incomplete.

• When you select the Force Distribution rule, the following occurs:

• If a case encounters a rule where a report is due is locked, the system schedules the report based on the rule and does the following:

  • Generates the report on the due date.

  • Dynamically replaces the current case comment with the force distribution case comment.

  • Transmits the report based on the preferences defined by the reporting destinations.

  • Displays the status in the Worklist Bulk Transmit/Transmit ICSR dialog boxs.

• The AG Service Force Reporting process for expedited reports completes the process by:

  • Checking the reports required for force distribution

  • Locks the case (if it's not already locked)

  • Generates the reports and makes sure it is ready for transmission

• The notes for the Case Locking/Unlocking are the same as those defined as the common profile value for the Forces Distribution option; System is the user.

Letter Placeholder for the IND Cover Letter

• You can define a placeholder for the IND_SIMILAR_EVENTS table. The system uses data from this table to populate the Case Number, Protocol Number, Subject ID, and Adverse Event terms for previously submitted cases reporting the same events.

• If no reports were submitted, the system prints None Submitted instead of the table.

  The placeholder only prints this information when it is used in the cover letter for the Regulatory Report. The system uses the license associated with the scheduled report to track other cases where the same product license was previously submitted for the same events in the current case.

6.1.1.2.1 Periodic Report—Fields and Field Descriptions

6.1.1.2.8 Report Generation Status

The Report Generation Status tab is displayed for users who have been configured by the Argus Safety administrator in Argus Console, under Access Management > Groups > Menu > Reports > Periodic Reports and for users who have access to the System Library.

Field	Description
Run At Date	Displays the date and time when the report generation started. For English users, it is displayed in DD-MMM-YYYY HH:MM:SS (GMT offset) format. For Japanese users, it is displayed in YYYY/MM/DD 00:00 (GMT offset) format
Status	Displays the current status of report generation in the form of hyperlinks, with the options listed below: Executing Error Pending Generated On clicking the Generated status, the Periodic Report is displayed. On selecting any status other than Generated, the Background Periodic Report Execution Status dialog box is displayed, as shown below: This dialog box displays the different stages of Periodic Report status. A grey tick mark is denotes Pending state, a Green tick mark denotes Completed State, and a Red cross mark denotes an Error.
Context Menu > View Report	This option is displayed in the context menu only when PDF/CSV/RTF Report Creation is Generated. On clicking View Report, the selected report is displayed. Applicable only for Periodic reports.

The Report Status screen displays the report outputs for the logged in user with the last report run as the first report. The reports can be filtered using:

• Report Name

• Draft/Final

• Report Type

• Scheduled By

• Scheduled On

• Run At Date

6.1.1.4.1 Submitting Reports

Before you can mark a report as submitted, the report must first be approved.

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

2. Open the Regulatory Reports tab in the Case Form.

3. When the system opens the Regulatory Reports details for the selected case, click the icon associated with the report you wish to approve.

4. Select View Report Details.

   Note:

   The Case Nullification Date is the date when the case is deleted, the Case Nullification Reason is the comment entered when the case is logically deleted in Argus.

5. Select Submitted from the State list in the Routing tab and click Route.

6. When the system opens a dialog box, enter the required details and click OK.

7. The report is approved.

Viewing Submitted Reports

Use the following procedure to view submitted reports.

1. Select the Reports -> Compliance -> Submitted Reports.

2. When the system opens the Submitted Reports page, enter the appropriate search criteria and click Search.

3. The system displays the Search Results.

Submitted Reports—Fields and Field Descriptions

6.1.1.4.2 Submitted Reports Search Results—Fields and Field Descriptions

6.1.1.4.3 Unsubmitting Reports

Cases that are archived while unsubmitting reports can be reopened from the Archived Case dialog box.

1. Enter the password and notes required in the Archived Case dialog box.

2. When the system opens the Report Unsubmit dialog box, enter the reason for unsubmitting the report and click OK.

3. The system unsubmits the report.

6.1.1.4.4 Lock State Header Options

Click the Lock State header row. A pop-up window appears, with the following sorting options:

• Lock State

• SUSAR

• Exp/Per

These options enable you to sort cases based on the case categorization.

6.1.2.2.1 Creating a Case Data Analysis Report

1. Select Reports -> Aggregate Reports -> Case Data Analysis.

2. In the Case Data Analysis Report view, select the information that must appear in the report.

3. In Row1, select the field the system uses to group cases by row.

4. In Column1, select the data the system uses to group cases by column.

5. In Row2, select the field by which each Row1 item will be categorized.

6. In Column2, select the field by which each Column1 item will be categorized.

7. Select a product family to which the report applies, if appropriate.

8. In Selection for Row1, select the value for row 1 by which the report must be restricted.

9. Specify an advanced condition, as appropriate.

10. Select Report Number of Cases or Report Number of Events, depending on the number of cases or the number of events to be entered in the report.

11. If you select Report Number of Events, you can specify the kind of events (serious listed, non-serious listed, serious non-listed, or non- serious non-listed) that will appear in the report.

12. Select whether only the top few items should be displayed and enter the number of items that should be displayed.

13. Check the Show% of Total checkbox to specify the percentage in each cell in the report.

14. Check the Blinded checkbox to hide blinded information in the report. This field is unchecked and disabled for a restricted user.

15. Check the Use Case Search Results checkbox to limit the Case Data Analysis only to the cases present in the Case Search dialog box.

16. Specify a date range for the cases that will appear in the report.

17. Enter a title for the report.

18. Click the Share this report with other users if there is a need to share the report/report output to other users. Note that the report may contain sensitive data. By default, the report is shared with all users. You can restrict it through Group, where the allowed user groups can be selected. When a report is shared for a user group, only members of that group and the report creator can access the report further.

19. The report can be used in the periodic report using Make available for use in Periodic Reports.

20. The Case Data Analysis report, in addition to the PDF and CSV format, supports the chart format too.

    This report output can be selected via Report Display Type field. The following chart types are available:

    • Bar Graph

    • Line Chart

    • Area

    • Pie

    • Donut

    • Stacked

      Note:

      The chart reports are run in sync and available only the user's browser and not stored in the database.

21. The Print button, executes and stores the report output which can be viewed under the system reports library.

22. The memorize button saves the report in the application. It does not execute the report.

6.1.2.3.1 Creating a CIOMS II Line Listing Report

1. Select Reports ->Aggregate Reports -> CIOMS II Line Listing.

2. On the CIOMS II Line Listing Criteria tab, select information for the header, footer, product family, advanced condition (if any), cases to include, and date.

3. Select either the Case Creation Date or Case Receipt Date radio button and specify a date range to run the report.

   Note:

   If you perform a search and return a list of cases to the Case Search screen, the Use Case Search Results is visible. Checking this box will disable all selection criteria with the exception of Include Unlocked Cases. For example, the Advanced Condition and Date Range will be disabled.

4. In the Line Listing tab, add or remove the appropriate fields.

5. In the Grouping tab, add or remove elements, insert a page break and change the sort order (if desired).

6. Click Memorize to open the Memorized Report dialog box.

7. Click Print to execute and save the report.

8. This report can be shared with other users of Argus and the sharing can be restricted through the User Group selection.