Configuring Reporting

The Reporting Configuration screen enables you to modify the options available for reporting. Select System Configuration > System Management to view the Common Profile Configuration screen

Tip:

The Common Profile folder appears in a tree-view on the left panel. The components are categorized as folders. Each folder contains all the field labels associated with that section.

To configure the fields associated with the Reporting section, click the Reporting folder in the left panel. The configurable fields associated with Reporting appear in the right panel.

Field Descriptions

The following table lists the fields available under Reporting:

Field or Control Name	Description
Allow User to regenerate reports	The available options are Yes and No.
Determine the minimum length of the routing comment text length on report routing dialog	The available options are: No routing comment will be required Minimum length of text required

Use the following procedure to configure reporting.

1. Select the option for Determine the minimum length of the routing comment text length on report routing dialog.
2. Enter the numeric value in the Minimum length of text required text-box, if applicable.
3. Click Save to save the changes made to this screen.

Configuring E2B

This screen enables you to configure the E2B fields and items for E2B. Select System Configuration > System Management to view the Common Profile Configuration screen

Tip:

The Common Profile folder appears in a tree-view on the left panel. The components are categorized as folders. Each folder contains all the field labels associated with that section.

To view the list of field names associated with the E2B section, click the E2B folder in the left panel. The field names associated with E2B appear in the right panel.

Field Descriptions

The following table lists the fields available under E2B:

Field or Control Name	Description
Auto Accept Notes	Enables you to enter notes (up to 190 characters). It is required for these notes to be entered for the acceptance of the E2B. The notes entered here, are automatically provided during E2B acceptance.
Blind status during E2B report generation	The available options are: Blinded Unblinded
Default DTD	Enables you to select the Default DTD from the drop-down list box.
Default view for E2B(R3)	Specifies the default view of E2B(R3) reports in the ICSR viewer. Decoded, HL7, and XML are the available options.
Default viewing format of the E2B report (used in E2B(R2) reports)	The available options are: SGML CIOMS MEDWATCH DECODED VIEW
Default viewing format of the E2B(R3) report	The default viewing format of the E2B(R3) report will be applicable to MFDS E2B(R3) and NMPA E2B(R3) reports.
Drug assessment method (used by E2B/Interchange module)	Enables you to incorporate the drug assessment method used by E2B/Interchange module.
File attachments allowed for ICH E2B(R3) Profile	Verifies the applicable files that can be attached with an E2B(R3) report generated using the ICH profile.
File attachments allowed for EMA E2B(R3) Profile	Verifies the applicable files that can be attached with an E2B(R3) report generated using the EMA profile.
File attachments allowed for MFDS E2B(R3) Profile	Verifies the applicable files that can be attached with an E2B(R3) report generated using the MFDS profile.
File attachments allowed for NMPA E2B(R3) Profile	Verifies the applicable files that can be attached with an E2B(R3) report generated using the NMPA profile.
Onset Date Calculation	Enables you to configure if the onset date is to be calculated based on any suspect drug or on the primary suspect drug only.
Send E2B nullification report	Enables you to send an E2B nullification report. You can select whether to automatically schedule it or to not send the report.
Enable stripping of line breaks in attachment data for EMA E2B(R3) profile	Enables you to strip line break characters in encoded attachment data. The parameter applies only to the EMA E2B(R3) Profile and has 'Yes' and 'No' values. The default value is 'Yes'.
Regional Drugs Dictionary	Enables you to select one from a drop-down list. The list values will emulate the WHO dictionaries list in Case Form Configuration > Drugs drop-down.

Use the following procedure to configure E2B:

1. Enable the check-box option for Drug assessment method (used by E2B/ESM module), if required.
2. Select the option for Blind status during E2B report generation.
3. Select the option for Perform length check of Argus fields against E2B standard.
4. Select the option for Default viewing format of the E2B report (used with Electronic Submission Module (ESM)).
5. Select the option for Default DTD.
6. Select the required radio button under Onset Date Calculation, as applicable.
7. Enter the comments for the automatically generated notes, when an E2B is accepted, under Auto Accept Notes.
8. Click Save to save the changes made to this screen.

Configuring eMDR

The eMDR Reporting Configuration screen enables you to modify the options available for eMDR reporting.

Select System Configuration > System Management to view the Common Profile Configuration screen.

To configure the fields associated with the Reporting section, click the Reporting folder in the left panel. The eMDR sub-folder is displayed in the left panel. Click this sub-folder to configure the reporting options. The configurable fields associated with eMDR appear in the right panel.

Field Descriptions

The following table lists and describes the fields available under eMDR:

Field or Control Name	Description
Default Timeframe for draft eMDR generation	Displays a time frame that the Draft report generation required for populating G7 (gtypeofreport). Without this information, eMDR throws a validation error and the report cannot be generated. The default setting for this parameter is 5. The allowed values for this parameter are 5, and 30. Based on the value entered, the corresponding NCI code is populated for data element Type of Report (G7) in eMDR.
File attachments allowed for eMDR	Verifies the files that are attached to an eMDR. Only configured file types are allowed to be attached to an eMDR.
Default view for eMDR	Specifies the default view of eMDR in ICSR viewer.

Configuring eVAERS

The eVAERS Reporting Configuration screen enables you to modify the options available for eVAERS reporting.

Select System Configuration > System Management to view the Common Profile Configuration screen.

Tip:

The Common Profile folder appears in a tree-view on the left panel. The components are categorized as folders. Each folder contains all the field labels associated with that section.

To configure the fields associated with the Reporting section, click the Reporting folder in the left panel. The eVAERS sub-folder is displayed in the left panel.

Click this sub-folder to configure the reporting options. The configurable fields associated with eVAERS appear in the right panel.

Field Descriptions

The following table lists and describes the fields available under eVAERS:

Field or Control Name	Description
Default view for eVAERS	Enables you to select either XML View or HL7 view as the default view for eVAERS.
File attachments allowed for eVAERS	Enables you to specify the types of files which are allowed as attachments for eVAERS.
Allowed file size for eVAERS (in MB)	Enables you to specify the maximum file size (in MB) allowed in eVAERS.

Expedited Reports Configuration

The Expedited Reporting Configuration screen enables you to modify the options available for expedited reporting. When configuring expedited reporting rules, be aware of the following:

• If the user does not have permission to access Advanced Conditions on the Expedited Reporting Rules, the system does the following:

  • Displays the advanced condition name instead of displaying a blank.
  • Does not permit the user to modify or view advanced condition details.
  • Disables the Adv Condition button.
• The system enables you configure the Blinding Study Products option for those included in the case (default unchecked).
  • The system track updates to this field in the audit log.
  • The Reporting Rules reports print the new options
• For cases where expedited reports are due, you can force-distribute expedited reports even if processing is incomplete.
• The reporting rules have a Forced Distribute XXX days before due check box. The default is unchecked.
  • If you checks the Force Distribute option, the # of days before due field is entered and automatically checks the Auto Distribute check box on the reporting rule (grayed out).
  • You can enter the number of days from 0 - # of days defined within the time frame.
  • If you enters a value greater than the defined time frame, the system displays the following message: Please enter a value less than the Time Frame defined for the Reporting Rule.
  • If you has not checked Force Distribute, the system disables the days before due.
• The system tracks updates made to the new Argus Console fields in the audit log.
• The system prints the new fields on the Reporting Rules report.

Select System Configuration > System Management to view the Common Profile Configuration screen.

Tip:

The Common Profile folder appears in a tree-view on the left panel. The components are categorized as folders. Each folder contains all the field labels associated with that section.

To configure the fields associated with the Reporting section, click the Reporting folder in the left panel. The Expedited sub-folder opens in the left panel.

Click the Expedited sub-folder to configure the expedited reporting options. The configurable fields associated with Expedited Reporting open in the right panel.

Field Descriptions

The following table lists and describes the fields available under Expedited Reporting:

Field or Control Name	Description
Active moiety report scheduling evaluation (a report scheduled against a product/license that shares ingredients with a product in a case)	The available options are: Enable Disable (default)
Allows Bulk Reporting screen to show Unlocked Cases for Final Report	The available options are: Report by Form and Bulk Report By Case will filter final reports by Locked Cases only Bulk Report By Form and Bulk Report By Case will allow selection of unlocked cases to be submitted as Final
Allows Bulk Reporting screen to show Generated Reports Only	Enables the administrator to allow the Bulk Reporting screen to display only the generated reports.
Nomenclature System on EU Device Vigilance Form	Nomenclature system (Preferable GMDN)" box of EU Device Vigilance Form. By default, this common profile switch is set to 'GMDN'.
Default name of Regulatory Agency for Draft Expedited English Reports	This enables you to select the Default Name of the Regulatory agency from the drop-down list.
Text to display as comment when a downgrade report is scheduled	This enables you to enter the text to display when a downgrade report is scheduled.
Auto Distribution Transmission Comments	Enables you to enter transmission comments of up to 2000 characters, for Expedited Reports Transmission. These comments are auto-distributed, based on Expedited Reporting Rules or Reporting Destinations.
Auto Distribution Submission Comments	Enables you to enter submission comments of up to 2000 characters, for Expedited Reports Transmission. These comments are auto-distributed, based on Expedited Reporting Rules or Reporting Destinations.
Print Case Version of Expedited Reports (x.y.z)	This switch enables you to enable or disable the printing of the case version of expedited reports.
SQL mapping for CIOMS/CERFA/MHRA Spontaneous/EU EMEA Spontaneous/Spanish Clinical/Spanish Spontaneous Literature Report Source (Parameters: P_CASE_ID)	For more details on the default mapping, refer to the Mapping Document.
Allow Generation of report	If you select Only when previously scheduled reports are submitted or marked for "submission not required" (default), the system retains the existing check for the previous reports that are in the Submission decision complete state. For example, the previous report has been either marked as Submitted or as Submission not required before a report can be generated. When the Even when previously scheduled reports are neither submitted nor marked for "submission not required" option is selected and the Create as Follow-up option is selected in Argus Console > System Configuration > System Management (Common Profile Switches) > Case Form Configuration > Report Generation section, the system removes the existing check for the previous reports that are in a Submission decision complete state. For example, the previous report has been either marked as Submitted or as Submission not required and the report can be generated irrespective of the previous report state (Generated, Approved, New Data Available states). Note: When a previous report is in a Deleted state, it can be removed on subsequent case save and the current report can be generate. When a previous report is set to the Disapproved state, no further follow-ups are scheduled. When a previous report is set to the No Longer Required state, Only when previously scheduled reports are submitted or marked for “submission not required” option determines you to mark the report to Submission not required to generate the current report. Even when previously scheduled reports are neither submitted nor marked for "submission not required" option lets you generate the current report, but the change to the No Longer Required state of the previous report does not determine you to mark the report for Submission not required. Note: When you generate a report while the previous report is waiting a submission decision, the initial or follow-up sequence numbering in the Regulatory Reporting tab does not synchronize consistently with the report type data output within the report itself (for example, Type of Report/G7 in Medwatch).

Use the following procedure to configure expedited reports.

1. Select the option for Active moiety report scheduling evaluation (a report scheduled against a product/license that shares ingredients with a product in a case).
2. Select the option for enables Bulk by Form to show Unlocked Cases for Final Report.
3. Select the option for Default name of Regulatory Agency for New Draft Expedited Reports from Analysis Tab of the Case Form from the drop-down text-box.
4. Enter the text in the Text to display as comment when a downgrade report is scheduled text-box, if applicable.
5. Enter the transmission comments in Auto Distribution Transmission Comments.
6. Enter the submission comments in Auto Distribution Submission Comments.
7. Select whether to enable or disable printing the case version of expedited reports in Print Case Version of Expedited Reports (x.y.z).
8. Click Save to save the changes made to this screen.

BIP Reporting

Oracle Argus Safety uses the BI Publisher reporting technology for the PMDA (R3) Paper reports and Flexible Aggregate reports (DSUR, PBRER and PMAR). This screen contains the common fields that are needed for integrating the BI Publisher server with Argus Safety.

Select System Configuration > System Management to view the Common Profile Configuration screen.

To configure the fields associated with the Reporting section, click the Reporting folder in the left panel. The BIP Reporting sub-folder is displayed in the left panel.

Click this sub-folder to configure the reporting options. The configurable fields associated with BIP Reporting appear in the right panel.

Field Descriptions

The BIP Reporting fields are grouped into Common and Aggregate reporting.The following table lists and describes the fields available under these sections:

Common

The fields under this section are common to both PMDA (R3) Paper Reports and Flexible Aggregate Reporting. These fields are critical to authenticate Oracle Argus Safety with BI Publisher.

Field or Control Name	Description
BIP Common User	Enables you to enter the name of the BIP common user.
BIP Common User Password	Enables you to enter the password of the BIP common user.

Aggregate Reporting

The fields under this section are applicable only to Flexible Aggregate Reports.

Field or Control Name	Description
Persist data in BIP Aggregate Temp Tables	Enables you to select whether to persist data in BIP Aggregate Temporary Tables. The available options are: Yes No
Number of days for which data of BIP Aggregate Temp Tables should be persisted	Enables you to specify the number of days for which data in BIP Aggregate Temporary Tables should be persisted.

Expedited BfArM Reports Configuration

The Expedited BfArM Reporting Configuration screen enables you to modify the options available for expedited BfArM reporting.

Select System Configuration > System Management to view the Common Profile Configuration screen.

To configure the fields associated with the Reporting section, click the Reporting folder in the left panel. The Expedited- BfArM sub-folder is displayed in the left panel.

Click the Expedited-BfArM sub-folder to configure the expedited BfArM reporting options. The configurable fields associated with Expedited - BfArM Reporting appear in the right panel.

Field Descriptions

The following table lists and describes the fields available under Expedited - BfArM Reporting:

Field or Control Name	Description
Causality Value on BfArM Report	The available options are: beh.Azrt Hersteller Arznel.Komm
Value of field "Grunderkrankung" on the BfArM/PEI form	The available options are: Do not output suspect and concomitant product indication in this field Output additional suspect and concomitant product Events & Indications.

Use the following steps to configure the expedited BfArM reports.

1. Select the option for Causality Value on BfArM Report.
2. Select the option for Value of field Grunderkrankung on the BfArM/PEI form.
3. Click Save to save the changes made to this screen.

Expedited Canada Reports Configuration

The Expedited Canada Reporting Configuration screen enables you to modify the options available for expedited Canada reporting.

Select System Configuration > System Management to view the Common Profile Configuration screen.

Tip:

The Common Profile folder appears in a tree-view on the left panel. The components are categorized as folders. Each folder contains all the field labels associated with that section.

To configure the fields associated with the Reporting section, click the Reporting folder in the left panel. The Expedited- Canada sub-folder is displayed in the left panel.

Click on the Expedited-Canada sub-folder to configure the reporting options. The configurable fields associated with Expedited - Canada Reporting appear in the right panel.

Field Descriptions

The following table lists and describes the fields available under Expedited- Canada Reporting:

Field or Control Name	Description
SQL used to populate the "Health Canada assigned company identification number" field on the Canadian Device report form	This field enables you to enter the associated SQL syntax.
SQL used to populate the "Establishment License Number" field on the Canadian Device report form	This field enables you to enter the associated SQL syntax.
SQL used to populate the "Device Identification No" field on the Canadian Device report form	This field enables you to enter the associated SQL syntax.
SQL used to populate the "Age of Device" field on the Canadian Device report form	This field enables you to enter the associated SQL syntax.
SQL used to populate the "How long was the device in use?" field on the Canadian Device report form	This field enables you to enter the associated SQL syntax.
Offset from GMT used to calculate Canada date/time fields (in hours)	This switch enables the GMT offset to the Submitted dates getting printed in Canadian Device Form.
SQL used to populate the "If "preliminary" only, anticipated date for the final report" field on the Canadian Device report form	This field enables you to enter the associated SQL syntax.
SQL used to populate the "Name of Health Care Facility" field on the Canadian Device report form	This field enables you to enter the associated SQL syntax.
SQL used to populate the "Name and Address for Manufacturer(A7)" field on the Canadian Device report form	This field enables you to enter the associated SQL syntax.
SQL used to populate the "Is there a new drug submission for this drug under review in Canada" field on the Canadian Expedited ADR report form	This field enables you to enter the associated SQL syntax.
SQL used to populate the "Is there a clinical trial application for this drug under review in Canada" field on the Canadian Expedited ADR report form	This field enables you to enter the associated SQL syntax.
SQL used to populate the "Is there an ongoing clinical trial for this drug in Canada" field on the Canadian Expedited ADR report form	This field enables you to enter the associated SQL syntax.
SQL used to populate the "Report ADR occurred in Phase I-IV Study" field on the Canadian Expedited ADR report form	This field enables you to enter the associated SQL syntax.
SQL used to populate the "Report ADR occurred in Phase I-III Study" field on the Canadian Expedited ADR report form	This field enables you to enter the associated SQL syntax.

Use the following procedure to configure Expedited Canada reports.

1. Enter the SQL syntax for SQL used to populate the "Is there an ongoing clinical trial for this drug in Canada" field on the Canadian Expedited ADR report form.
2. Enter the SQL syntax for SQL used to populate the "Is there a clinical trial application for this drug under review in Canada" field on the Canadian Expedited ADR report form.
3. Enter the SQL syntax for SQL used to populate the "Is there a new drug submission for this drug under review in Canada" field on the Canadian Expedited ADR report form.
4. Enter the SQL syntax for SQL used to populate the "Report ADR occurred in Phase I-III Study" field on the Canadian Expedited ADR report form.
5. Enter the SQL syntax for SQL used to populate the "Report ADR occurred in Phase I-IV Study" field on the Canadian Expedited ADR report form.
6. Click Save to save the changes made to this screen.

Expedited CIOMS Reports

The Expedited CIOMS Reporting Configuration screen enables you to modify the options available for expedited CIOMS reporting. Select System Configuration > System Management to view the Common Profile Configuration screen.

Tip:

The Common Profile folder appears in a tree-view on the left panel. The components are categorized as folders. Each folder contains all the field labels associated with that section.

To configure the fields associated with the Reporting section, click the Reporting folder in the left panel.

The Expedited- CIOMS sub-folder is displayed in the left panel. Click the Expedited-CIOMS sub-folder to configure the expedited CIOMS reporting options.

The configurable fields associated with Expedited - CIOMS Reporting appear in the right panel.

Field Descriptions

The following table lists the fields available under Expedited- CIOMS Reporting:

Field or Control Name	Description
CIOMS Form Selection	This enables you to select the CIOMS form to be used across the application for Expedited Reporting / Periodic Reporting.
CIOMS report format to use	The available options are: Standard Custom When Custom is selected, a second version of the CIOMS form is used. This form is almost identical to the Standard form. The only difference is that the Custom form includes superscripts in the label text for boxes 15, 16, 18 and 19. The superscript is simply an asterisk (*) to draw the user's attention to the following footnote also included in the Custom form: *Boxes 15, 16, 18, and 19 on page 1 contain first dose regimen information for suspected product #1 and #2. Suspected Drug(s) information is continued on Additional Information page, if applicable. Thus, the Custom form simply provides you the option to clearly identify fields that have overflow information on the Additional Information page.
Print Patient ID, Study ID, Center ID in 26. REMARKS section of the CIOMS form	Enables you to print the Patient ID, Study ID and Center ID fields in the "26. REMARKS" section of the CIOMS form.
Print Medically Confirmed in the 26. REMARKS section of the CIOMS form	Enables you to print Medically Confirmed in the 26. REMARKS section of the CIOMS form.
Print World Wide Number in the 26. REMARKS" section of the CIOMS form	Enables you to print World Wide Number in the "26. REMARKS" section of the CIOMS form.

Use the following procedure to configure the expedited CIOMS reports.

1. Select the Print Patient ID, Study ID, Center ID in the "26. REMARKS" section of the CIOMS form checkbox to print these fields in the CIOMS form.
2. Select the Print Medically Confirmed in the "26. REMARKS" section of the CIOMS form checkbox to print this field in the CIOMS form.
3. Select the Print World Wide Number in the "26. REMARKS" section of the CIOMS form checkbox to print this field in the CIOMS form.
4. Select the option for CIOMS report format to use.
5. Select the relevant CIOMS form, from CIOMS Form Selection.
6. Click Save to save the changes made to this screen.

Expedited MedWatch Reports Configuration

The Expedited MedWatch Reporting Configuration screen enables you to modify the options available for expedited MedWatch reporting.

Select System Configuration > System Management to view the Common Profile Configuration screen.

Tip:

The Common Profile folder appears in a tree-view on the left panel. The components are categorized as folders. Each folder contains all the field labels associated with that section.

To configure the fields associated with the Reporting section, click the Reporting folder in the left panel. The Expedited- MedWatch sub-folder is displayed in the left panel.

Click the Expedited-MedWatch sub-folder to configure the expedited MedWatch reporting options. The configurable fields associated with Expedited - MedWatch Reporting appear in the right panel.

Field Descriptions

The following table lists the fields available under Expedited- MedWatch Reporting:

Field or Control Name	Description
Value for Field E4 on MedWatch	Select the applicable value from the available options.
Data to print on follow up MedWatch Device form	The available options are: All information (initial and follow-up) is displayed. (Previous Behaviour). Only Display changed information from the initial report.
Number from LM_REF_TYPES.REF_TYPE_ID for Reference Type containing Legacy Case Number (to print MedWatch forms)	This field enables you to select the required option from the drop-down list.
SQL used to print the BLA #	Enables you to enter the SQL query used to print the BLA#.
SQL used to print Unique Identifier (UDI #) in MedWatch Device Form	Enables you to enter the SQL query used to print the UDI# in MedWatch Device Forms.
License number on MedWatch Drug Report	The available options are: Print License # only for the scheduled license on MedWatch Drug Report Print all available license numbers for Drug as determined by the scheduled license
License number on MedWatch Drug Report	This field enables you to select the option for License number on MedWatch Drug Report.
SQL mapping for MedWatch Literature Box 3. Report Source (Parameters: P_CASE_ID)	SQL mapping for the field: "This type includes cases from literature" for MedWatch. For more details on the default mapping, refer to the Mapping Document.
Value for Field G8 on MedWatch	Select the applicable value from the available options.

Use the following procedure to configure expedited MedWatch reports.

1. Select the option for the Value for Field E4 on MedWatch.
2. Select the option for the Data to print on follow up MedWatch Device form.
3. Select the required option for Number from LM_REF_TYPES.REF_TYPE_ID for Reference Type containing Legacy Case Number (to print MedWatch forms) from the drop-down list box.
4. Select the option for License number on MedWatch Drug Report.
5. Add an SQL for BLA# and UDI#, if there is a need to change the default logic for these fields in MedWatch report.
6. Click Save to save the changes made to this screen.

Configuring MedWatch

The MedWatch Configuration screen enables you to modify the customizable fields on the MedWatch form. Select System Configuration > System Management to view the Common Profile Configuration screen.

Tip:

The Common Profile folder appears in a tree-view on the left panel. The components are categorized as folders. Each folder contains all the field labels associated with that section.

To view the list of field names associated with the MedWatch Configuration section, click the MedWatch Configuration folder in the left panel.

The field names associated with MedWatch Configuration appear in the right panel.

Field Descriptions

The following table lists and describes the fields available under MedWatch Configuration:

Field or Control Name	Description
Firm Name as it Should Appear at the Top of Each Page	Enables you to enter the name of the reporting firm on the MedWatch form.
Use Manufacturer of the License Used for Report scheduling	Enables you to use the manufacturer of the license that was used for report scheduling, by checking this checkbox.
Date of FDA Approval to Appear on the First Page	Enables you to enter the FDA approval date of the manufacturer.
Disclaimer to appear at the Bottom of the First Page	Enables you to enter a brief disclaimer.
Default text to appear on Block H10	Enables you to enter default text.
Address to be printed at the bottom of Second page of MedWatch Device Form	Enables you to enter the address to be printed at the bottom of Second page of MedWatch Device Form. The default address is as follows: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]
Reset MedWatch Numbering	Enables you to reset the sequence number that appears on the MedWatch form for the manufacturer.
Mfr. Site FDA Number	Displays the FDA number for the Manufacturer Site which submitted the MedWatch 3500 Device report in the year.
Year	Displays the year of report submission.
# of Reports	Displays the number of submitted reports for products associated with a Manufacturing Site in that year.
Reset Number	Enables you to reset the Sequence Number.

Use the following procedure to configure the MedWatch form options.

1. Enter the Firm Name as it Should Appear at the Top of Each Page.
2. Enter the Date of FDA Approval to appear on the first page.
3. Enter the Disclaimer to appear at the bottom of the first page.
4. Enter the Default text to appear on Block H10.
5. Click Reset MedWatch Numbering to reset the sequence number that appears on the MedWatch form, for the manufacturer as required.

Periodic Reports Configuration

The Periodic Reporting Configuration screen enables you to modify the options available for periodic reporting.

Select System Configuration > System Management to view the Common Profile Configuration screen.

Tip:

The Common Profile folder appears in a tree-view on the left panel. The components are categorized as folders. Each folder contains all the field labels associated with that section.

To configure the fields associated with the Reporting section, click the Reporting folder in the left panel. The Periodic sub-folder is displayed in the left panel.

Click the Periodic sub-folder to configure the periodic reporting options. The configurable fields associated with Periodic Reporting appear in the right panel.

Field Descriptions

The following table lists and describes the fields available under Periodic Reporting:

Field or Control Name	Description
Determine Primary Event for use in ICH PSUR/CTPR report	The available options are: Primary Event (Left Most Diagnosis or the left-most Event if there is no Diagnosis on the Case Form). Most severe event for the product (First left most Diagnosis Related Serious Event with most weight on Diagnosis then relatedness and then seriousness).
Listedness grouping logic for ICH PSUR/CTPR report output	The available options are: Primary Event (refer to Inclusion criteria of event for a product in the PSUR/CTPR switch). Case level Listedness
Seriousness grouping logic for ICH PSUR/CTPR report output	The available options are: Primary Event (refer to Inclusion criteria of event for a product in the PSUR/CTPR switch). Case level seriousness
Inclusion Criteria for cases in the ICH PSUR/CTPR report	The available options are: Evaluate seriousness, listedness, relatedness, fatal across all diagnoses/events against product When this option is selected, the case inclusion criteria logic in ICH PSUR/CTPR scans all the diagnoses in the case and matches all the Seriousness, Listedness, Relatedness, Fatal values for the diagnosis in the case against the product(s) for which the report is being run, with the corresponding values selected by you in the Report configuration. When there are no diagnosis in the case, the system scans all the events in the case and matches all the Seriousness, Listedness, Relatedness, Fatal values for the events in the case against the product(s) for which the report is being run, with the corresponding values selected by you in the Report configuration. When multiple products are configured in the report, a match of all the Seriousness, Listedness, Relatedness and Fatal values against even one product-diagnosis is considered as a match for including the case. Evaluate case inclusion based on following seriousness, listedness, causality option groups - Case Inclusion criteria for the ICH PSUR/CTPR report based on Seriousness OR Case Inclusion criteria for the ICH PSUR/CTPR report based on Causality OR Case Inclusion criteria for the ICH PSUR/CTPR report based on Listedness.
Determine Possible Causality from the causality score	This field enables you to enter a numeric value.
Determine Probable Causality from the causality score	This field enables you to enter a numeric value.
On PSUR, NDA, IND, Medical Review List Reports	The available options are: Use Initial Receipt Date for date range search Use Safety Date for date range search
Print footnote 'Non-Serious Listed' for non-serious listed cases in ICH PSUR report	The available options are: Yes No
Assessment of Listedness and Causality when both Licenses and Studies are selected in CTPR	The available options are: Based on selected liscenses Based on selected studies

Use the following procedure to configure periodic reports.

1. Select the option for Inclusion Criteria for cases in the ICH PSUR report.
2. Select the option for Print footnote Non Serious Listed for non-serious listed cases in ICH PSUR report.
3. Select the option for Inclusion criteria of event for a product in the PSUR.
4. Enter the value for Determine Possible Causality from the causality score.
5. Enter the value for Determine Probable Causality from causality score.
6. Select the option for On PSUR, NDA, IND, Medical Review List Reports.
7. Click Save to save the changes made to this screen.

Scheduling Reports Configuration

The Scheduling Reports Configuration screen enables you to modify the options available for scheduling reporting. Select System Configuration > System Management to view the Common Profile Configuration screen.

Tip:

The Common Profile folder appears in a tree-view on the left panel. The components are categorized as folders. Each folder contains all the field labels associated with that section.

To configure the fields associated with the Reporting section, click the Reporting folder in the left panel. The Scheduling sub-folder is displayed in the left panel.

Click the Scheduling sub-folder to configure the scheduling report options. The configurable fields associated with Scheduling Reports appear in the right panel.

Field Descriptions

The following table lists and describes the fields available under Schedule Reports:

Field or Control Name	Description
Report Scheduling	The available options are: Report Scheduling will be run by the Middle Tier Service All report scheduling will be done locally on the client machine
Enable separate scheduling of device reporting rules from drugs and vaccines	The available options are: Yes No
Report Scheduling Causality Operand	Enables you to select from the causality operands AND/OR to use for scheduling a report.

Use the following procedure to configure scheduling.

1. Select the option for Report Scheduling.
2. Select the option for Enable separate scheduling of device reporting rules from drugs and vaccines.
3. Select the operand to use for scheduling a report from Report Scheduling Causality Operand.
4. Click Save to save the changes made to this screen.