4 Reports

4.1.2.1 Additional Expedited Report Updates

The Expedited reports which are faxed to the PMDA need to be identified by which receiver is sending the information. This is done by the Additional Header information on the report output.

• The following profile switches are added to Console > System Configuration > Argus J > Reporting. These switches are specific to the Enterprise:

  #	Field Label	Field Length
  1	Marketed: Form 1,2	40
  2	Marketed: Form 3,4	40
  3	Marketed: Form 5,6	40
  4	Investigational: Form 1,2	40
  5	Investigational: Form 3,4	40
  6	Investigational: Form 5,6	40

  
  

  These switches are depicted in the following figure:

  
  

• The Reporting Destination Configuration has an Include FAX Header on PMDA Paper Reports Argus J user-specific checkbox on the Agency Configuration tab.

  
  

• This checkbox is enabled only when FAX is selected as the Preferred Method and is reset to disabled and blank when Preferred Method is set to something else.

• By default, this field is unchecked for existing and newly created Reporting Destinations.

• You can mark this option for a Reporting Destination and the changes made to this flag are audit logged and printed as part of Codelist Maintenance Print PDF.

• Fax header is printed only if the Include FAX Header on PMDA Paper Reports is marked for that Reporting Destination.

  
  

• Text entered in the Common Profile Switch is printed on the first page of the PMDA Paper Report:

  • Fax header text is printed in MS Mincho font of size 16.

  • Fax header text is printed in the line below the Report Format Number and is aligned to the left.

    Figure 4-2 Fax Header in R2 Paper Report

    
    

    Figure 4-3 Fax Header in R3 Paper Report

    
    

  • If you clear the Fax Header Text for the PMDA Paper reports in the Common Profile Switch, the header is left blank in the report.

    Note printed on PMDA Paper Reports > Marketed Forms 1, 3 and 5 is removed as it is a data entry description (for FAX as well as when sent through Email ) Report	Note to be removed (English Translation)
    Marketed Form 1	Note: Format No.2(1) to (5) have to be attached
    Marketed Form 3	Note: Form 4 should be attached together.
    Marketed Form 5	Note: Attach Form 6 together.

    
    

    The following figure depicts the PMDA Paper Report Sample:

    
    

• PMDA Marketed Form 1 and 2, and PMDA Investigation Form 1 and 2 Paper Report generation logic are enhanced to be in synchronization with CIOMS and MedWatch reports for different type of users.

  User	Description
  Restricted	User for whom Console > Access Management > Argus > User > "Protect from Printing Unblinded Information" is checked.
  Non-Restricted User	User for whom Console > Access Management > Argus > User > "Protect from Printing Unblinded Information" is not checked.
  Blinded Study Case	Case with a blinded study which is still not eligible for unblinding irrespective of the fact that the blind for the case is broken or not it shall be considered as a blinded case.
  Blinded Report	The report for which the configured Blind Study Product is marked as Yes.

  
  

  • When a restricted user generates/prints the report for a Blinded Study Case (Blinded report and Not Blinded report), if the "Blind in PMDA AE Paper Report" checkbox is selected, the profile elements are printed as blinded.

  • When a Non-Restricted user generates:

    Blinded Report: The application generates/prints a report as a Blinded Study Case, if the "Blind in PMDA AE Paper Report" checkbox is selected, and the profile elements are listed as blinded.

    Not Blinded Report: A "Do you want to hide Unblinded Information?" dialog box appears.

    If you select "No", the report is printed without blinding the any information.

    If you select "Yes", the report is printed after blinding the profile elements for which "Blind in PMDA AE Paper Report" checkbox is selected.

  • For blinding B.4.K.2.1 MEDICINALPRODUCT and B.4.k.2.2 ACTIVESUBSTANCENAME, the report is printed in the following format:

    B_<Blinded Study Name>(B_<Study Level CCN)>)

  • Blinded G.k.2.2 & G.k.2.3.r.1/ G.k.2.3.r.2(a,b)/ G.k.2.3.r.3(a,b) are printed as:

    • G.k.2.2 MEDICINALPRODUCT—Prints <Study Level CCN> for the PMDA Paper report forms 1-2.

      For blinded output, when CCN from J2.12 tag is printed for G.k.2.2, J2.12 is suppressed, so that it is not repeated in the same field.

    • G.k.2.3.r.1/ G.k.2.3.r.2(a,b)/ G.k.2.3.r.3(a,b) ACTIVESUBSTANCENAME—Prints <Generic Name from Case form> for the PMDA Paper report forms 1-2.

      In case G.k.2.3.r.1 is required to be printed along with G.k.2.3.r.2 or G.k.2.3.r.3, for blinded output, the application prints <Generic Name from Case form> only once without repeating in place of G.k.2.3.r.2 or G.k.2.3.r.3.

    • For blinded output, products that are only study drugs are blinded. All non-study drugs in the case are not blinded in the Paper Form.

  • Blinding J.10/J2.11 (mhlwadmicsrreporttimesevent) element is governed based on the "Blind in PMDA AE Paper Report" in ESM Mapping and "Blind J.10/J2.11 in PMDA AE Paper" of the License for which the report is scheduled (PMDA E2B R2 or PMDA E2B R3 respectively).

    a. If in PMDA Profile, for J.10/J2.11 "Blind in PMDA AE Paper Report" is unchecked, then irrespective of the value the checkbox "Blind J.10/J2.11 in PMDA AE Paper " for the corresponding License against which the report (blinded or not blinded) is scheduled, and also irrespective of the Blinded status of the case, J.10/J2.11 is not be blinded for both Restricted as well as Non-Restricted user.

    b. If in PMDA Profile, for J.10/J2.11 "Blind in PMDA AE Paper Report" is checked:

    i. If the checkbox "Blind J.10/J2.11 in PMDA AE Paper " " for the corresponding License against which the report is scheduled is checked then irrespective of the Blinded status of the case when a restricted user prints/views the PMDA Paper Report Form 1-2 MKT/INV the application always Blinds the J.10/J2.11 data in the report, and when Non-Restricted user prints/views the PMDA Paper Report Form 1-2 MKT/INV:

    * Blinded Report: The application prints/views the PMDA Paper Report Form 1-2 MKT/INV, and always Blind the J.10/J2.11 data in the report.

    * Not Blinded report: The application prompts a "Do you want to hide Unblinded Information?" dialog box. If you select "No", then the report is printed without blinding the J.10/J2.11, but if select "Yes", then the report is printed after blinding the J.10/J2.11.

    ii. If the checkbox "Blind J.10/J2.11 in PMDA AE Paper " " for the corresponding License against which the report is scheduled is un-checked, and the case is a blinded study case, when a restricted user prints/views the PMDA Paper Report Form 1-2 MKT/INV the application Blinds the J.10/J2.11 data in the report, and when Non-Restricted user prints/views he PMDA Paper Report Form 1-2 MKT/INV:

    * Blinded Report: The application prints/views the PMDA Paper Report Form 1-2 MKT/INV, and always Blinds the J.10/J2.11 data in the report.

    * Not Blinded report: he application prompts a "Do you want to hide Unblinded Information?" dialog box. If you select "No", then the report prints without blinding the J.10/J2.11, but if you select "Yes", then the report prints after blinding the J.10/J2.11.

    iii. If the checkbox "Blind J.10/J2.11 in PMDA AE Paper" for the corresponding License against which the report is scheduled is un-checked and the Case is not a blinded study case, irrespective of the restricted and Non-Restricted user J.10/J2.11 is not blinded.

  • You can now print the submitted Blinded PMDA Paper Report from Reports > Compliance > Submitted Reports using Print Submitted Report without getting the following error:

    "Cannot print PMDA Paper Report for J E2B (Report Form Id = <report form id>, Case Num = <case num>) as user does not have access to blinded information."

4.1.2.2 Printed Paper Reports—Formatting Details

The general guidelines while printing the data in the paper form:

• Prints textual values instead of the coded values to aid human readability.

• If the number of rows to be printed in a multi-record section does not fit a page, then the same section is continued to the next page along with the table header until all the records are printed completely.

• If a non-repeatable field value exceeds the space available in the page, it is continued to the next page to print the overflowing value (like in MS word) until the full value is printed completely. All other fields are printed as per the format.

• The separators are used as:

  • Comma ','—Multi byte

  • Bracket '(' and ')'—Multi byte

  • Colon ':'—Multi Byte

  • Dash '-'—Single byte

• Null flavor printing is also supported in Paper Forms.

• True/False is printed in all forms as Yes/No respectively.

• A form starts only in a new page in the PDF irrespective of previous page data.

  For example, if Form 2 Page 1 data is printed from page 3 of a report till page 4, then Form 3 Page 2 data is printed starting from page 5 and not from page 4 itself.

• If the "Include FAX Header on PMDA Paper Reports" checkbox under the Reporting Destination > Agency Information tab is checked, then the Fax header is printed in the report as configured in the common profile switches for the respective PMDA paper report under Console > System Configuration > Argus J > Reporting.

  • Text entered in Common Profile Switch is printed on the first page of the PMDA Paper Report.

  • Fax header text is printed in MS Mincho with font size 16.

  • Fax header text is printed in the line below the Report Format Number and is aligned to the left.

• The page number is printed in the Footer (center aligned) for each page.

  Format: <Current Page Number>/<Total Number of pages>

• The report page number for each page (other than the main page 1, 3, and 5) is printed in the first table within the label .

  Format: Report page number<space>/<space>Total pages in that report

4.2.7.1 Format

The system allows the definition of PSR reports for products. The purpose is to define a fixed set of PSR reports for PRIMARY AGENCY (the various regulatory authorities as optional) and then associate products with these reports. The PSRs can then be scheduled automatically.

PSR applies only for Japanese licenses.

• The system contains a configuration screen to define a PSR report. A new menu item, Reports > Periodic Reports > PSR/ReSD Reports is created. When this is clicked, the following page is displayed.

  
  

PSR Main Window

• If the report is being currently opened by another for modification, the system displays the following message:
  The report which is selected is being used by XXXX and cannot be modified.
  where XXX is the full user name of the user has opened it.

• The labels and buttons related to the CSV files and FD validation reports are hidden in the Edit and View Report dialog box invoked for the PSR Report (Paper format), CSPR, and Seiyakukyo reports.

• The Create from Template button that is available on Argus E PSUR and CTPR section is not added for Japanese PSR, ReSD configuration.

• This page displays a list of the PSR reports stored in the system.

  • You can add a new report by clicking on the New Report button.

  • The Copy button makes a copy of an existing report:

    When you copy an existing PSR Report, all the configuration of the report including timeframe rows are copied.

    Report Name of new copy has copy of in front of the name.

    When the configuration is copied, the past dates in the schedule frequency, JAD, IBD, and Assigned date are also copied as read-only. The other sections of the copied configuration are editable.

    When you copy an existing non-submitted PSR report, all the configuration including timeframe rows are copied. As the original report is non-submitted, all the timeframe rows are retained as non-editable or editable as they were in the original PSR. The JAD, IBD, and Assigned Date become editable or non-editable depending upon if there are timeframe rows in the copied PSR which are non-editable.

  • The Modify button displays the report definition.

  • The Delete button allows you to delete a report after displaying the following confirmation message:
    Proceeding to Yes will remove the report configuration. Proceed?

  • Clicking Print, results in displaying a new dialog prior to report preview allowing you to select from several preview or direct export options: Word output.

• The Delete option is only available if there are no final reports generated for the Periodic Reports. The Delete option only hides the report from the list.

• In the recently executed Periodic Report section, a link is available for the last executed report only if the Report is still available on the Report Server.

• Clicking New or Modify in the above screen displays the PSR Configuration Window.

• Once the state of the report is changed to Submitted, you cannot update the configuration of that PSR. This is done by disabling the OK button. For example, when the state is un-submitted, the report is editable again. In addition, when the non-editable configuration is opened, the following warning message is displayed:
  This configuration is not modifiable because the status of this Periodic Safety Report is Submitted
  When you click OK, this displays the Configuration window.
  When you click Cancel, the configuration window is not displayed.

• When the status of the report is Submitted, only the configuration page is printed.

• The Copy can be done any time while the configuration exists.

  When you create PSR after 2nd time, the new copy of the configuration is required. You can then modify the content to print the current PSR.

• Before saving the PSR configuration, Report Name, Primary Agency, Product Selection, and at least one time frame need to have a value entered.

  When these are not entered, the following messages are displayed:
  
  When Report Name is not entered:

  Report Name is not entered

  When Primary Agency is not entered:

  Primary Agency is not entered

  When selected product is not available:

  Product is not selected

  When At least one time frame is not entered:

  Investigation time frame is not configured

  The following message is displayed along with the above error:

  It is necessary to enter above information in order to save the configuration

• When Modify, Copy, Delete, or Print button is clicked without a selection of report, a pop-up is displayed to select a report.

4.2.7.2 PSR /ReSD Details

4.2.7.2.1 Subject of Report

Field Name	Description
Report Name	Manually Input a Name for the Report. It is displayed in the Reports > PSR Reports dialog box.
Report Category	Manually Input a Name for a Report Category. It is displayed in the Reports > PSR Reports dialog box.
Primary Report Agency	This list contains the Regulatory Authorities configured in List Maintenance > Regulatory Authorities (LM_REGULATORY_CONTACT table). If there is no Japanese Authority name configured, the English name is listed. The system allows you to select multiple agencies from the List of Agencies such that the report can be submitted to multiple agencies at the same time.The primary agency can be defined in this drop- down.When Japanese Message Profile is not configured in Console J for the selected Primary Agency, or when you add the agency with PMDA E2B R3 (or R2) in the Report Configuration, an error message is displayed as: Selected Primary Agency doesn't have configured Message Profile (I or J) in Argus Console > Reporting Destination/EDI. Once you click OK, the selection of the Primary Agency goes back to the previous selection. This check is executed when you try to go to the other tab, or click OK to save the configuration.
Report Number	Manual entry text field that allows you to enter a report number.
Print all configuration criteria on separate cover page	Check box to print out the configuration of this report when the report is printed. When this is clicked, the Configuration page is printed at the beginning of the PSR/ReSD word print output. The page numbering of the PSR/ReSD does not include the Configuration page.

4.2.7.2.2 Product Selection

Field Name	Description
Available Ingredients	This list contains the Ingredients used for the products configuration. It is stored in the LM_PF_INGREDIENT_J table once a product has been configured. The system allows filtering the Ingredients within the available list of Ingredients by a entering the Ingredient name and clicking the Filter button. The search is performed in Japanese ingredient name only. If the name is blank, enter English ingredient name.
Filter
Indication	This list contains the Indication configured for the product containing the ingredient in C5 section. Use this to narrow down the products displayed in C8.The system allows to multi-select Indications using the standard Windows functionality of CTRL+CLICK.If Japanese name is not available, the English name is displayed.
Available Products	This list is auto-populated once the Ingredient has been selected and displays all products from the LM_PRODUCT J table, containing the ingredient selected in C5 section. The format is Product name (Formulation, Concentration concatenated with the Concentration Units). If Japanese name is not available, the English name is displayed. The withdrawn products are displayed as well.
Selected Ingredients	When an ingredient has been selected, all products containing that ingredient are displayed in Available Products section. Multiple Ingredients can be selected at once to form a PSR product family.
Formulation	This list contains the formulation configured for the product using the ingredient in C5 section (LM_FORMULATION table). Use this to narrow down the products displayed in C8.The system allows to multi-select formulations using standard Windows functionality of CTRL+CLICK.If Japanese name is not available, the English name is displayed.
Selected Products	This list contains products that are selected from the Available Products list (C8). When at least one product is selected, the field has a blue background color. If the license is not withdrawn at the starting date of the PSR investigation timeframe, include the license in PSR and ReSD.

Additional Information

• When no Japanese ingredients, indication, or formulation is configured in the Console, the English names are displayed.

• If the product is added or deleted in the Product Selection section before the PSR/ReSD status is marked as Submitted, it displays a warning pop-up:
  If the content of selected product is changed, IBD, JAD, and Assigned date can possibly be changed. Do you want to proceed?).

• If you add or delete the products in the Product Selection section before the first PSR report is marked as Submitted, it updates the IBD, Japan award date, and Assigned Date based on the new product set.

• When you copy an existing submitted PSR report, and JAD, IBD, Assigned dates are non-editable (you have not clicked the RESET button yet) and If you change the product selection, JAD, IBD and Assigned dates do not change. When this occurs, the following warning message is displayed:
  Because the configuration has the record of past investigation period, JAD, IBD, and Assigned Date for scheduling configuration will not be changed by modifying the Selected Products. It is necessary to use the Reset button and re-configure the investigation period if new PSR needs to be created based on modified product selection.

• All the forms printed as PSR and ReSD have only the information regarding the selected product in this configuration window.

4.2.7.2.3 Periodic Safety Report/ReSD

Field Name	Description
Forms configuration	This field represents the main title of the UI.
Periodic Safety Report	This radio button is available to select either PSR or ReSD, so that you can create PSR and ReSD independently.This is selected as Default
Re-examination Submission Dossier	This radio button is available to select either PSR or ReSD, so that you can create PSR and ReSD independently.
Data counting configuration
Count Configuration
Exclude events which don't meet the condition from the past data	When this is checked, the events that were reported in the past PSR, but do not meet the condition at the end of current investigational timeframe are subtractedEvent was downgradedReport was nullifiedWhen this occurs, following message is printed under the first table of form 3: Among the Events that were count in the past report, there are nullified/became non-reportable during this investigational time frame. This is not checked by default.
Exclude events which were reported by Paper report form	When this is checked, the events that were reported by Paper Form during the investigational time frame are excluded.This is not checked by default.
Exclude Incompletion report from output	When this is checked, the events reported as incompletion report during the investigational time frame are excluded.This is not checked by default
PSR Report Form 3
Form 3 Selection (Check box)	If this is checked, PSR Form3 is printed.This is checked by default.
Print Only the Term Preferred Term (Radio Button)Lower Level (Radio Button)	This field allows you to decide which term (PT or LLT) is to be printed on the form3.PT is selected by default.
Classify based on SOC	If this is checked, the PSR Form 3 PT/LLT section is grouped by SOC. In this case, the name of the SOC is listed at top of the section, and --- is used for separator between SOC and PT/LLT. Bold line is used for separating the groups.This is checked by default.
Print the report content as Case Listing in the separate paper	When this is checked, the case listing of the report content is printed out on a separate paper. All the configuration reflects the case listing.This is not checked by default.
PSR Report FORM 4
Form 4 Selection (Check box)	If this is checked, the PSR Form4 is printed.This is checked by default.
Print Only the Term	This field allows you to decide which term (PT or LLT)is to be printed on the form4.PT is selected by default.
Order SOC Alphabetically (Check box)	If this is checked, the SOC is printed in alphabetical order. If not checked, the SOC order is same as that of the MedDRA order.This is not checked as default.
Non-Serious Unlisted PSR Report
Drug Non-Serious, Unlisted PSR	This field represents the title of the section.
Paper ReportFD Report	Radio buttons:When Paper Report is selected, Paper report format is generated.When FD Report is selected, CSV report format is generated.When FD report is selected, both 7-1 and 7-2 forms are checked in the checkboxes and these cannot be edited. Paper Report is selected by default.
PSR Report FORM 7 - 1
Form 7-1 Selection (Check box)	If this is checked, the PSR Form7-1 is printed.This is checked by default.
Print Blank Form	By checking this, the blank form is printed.This is not checked by default.
PSR Report FORM 7 - 2
Form 7-2 Selection (Check box)	If this is checked, the PSR Form7-2 is printed.This is checked by default.
Print the report content as Case Listing in the separate paper	When this is checked, the Case listing of the report content is printed out on a separate paper.This is not checked by default.
Separate Page Numbering (Check box)	When this is checked, the Page number is independent (starts from 1) for each form.This is checked by default.
Use Current Case VersionUse DLP Case Version	This radio button control is only displayed if DLP is enabled. Use Current Case Version is selected by default.Based on the PSR Configuration for DLP, the report is executed accordingly using latest Case Revision or using the DLP Case Revision.
ReSD Report FORM 4
Form 4 Selection (Check box)	If this is checked, the ReSD Form4 is printed.This is checked by default.
Print Only the Term Preferred Term (Radio Button)Lower Level (Radio Button)	Allows you to decide which term (PT or LLT) you want to print on form4.PT is selected by default.
Classify based on SOC	If this is checked, the PSR Form 3 PT/LLT section is grouped by SOC. In this case, the name of the SOC is listed at the top of the section, and --- is used as separator between SOC and PT/LLT. Bold line is used for separating the groups.This is checked by default.
Print the report content as Case Listing in the separate paper	When this is checked, Case Listing of the report content is printed out on a separate paper.This is NOT checked by default.
ReSD Report FORM 5
Form 5 Selection (Check box)	If this is checked, the ReSD Form5 is printed.This is checked by default.
Print Only the Term	Allows you to decide which term (PT or LLT) is to be printed on form4.PT is selected by default.
Order SOC Alphabetically (Check box)	If this is checked, the SOC is printed in alphabetical order. If this is not checked, the SOC order is same as that of the MedDRA order.This is not checked by default.
ReSD Report FORM 7
Form 7 Selection (Check box)	If this is checked, the ReSD Form 7 is printed.This is checked as default.
ReSD Report FORM 8
Form 8 Selection (Check box)	If this is checked, the ReSD Form 8 is printed.This is checked by default.
ReSD Report FORM 9
Form 9 Selection (Check box)	If this is checked, the ReSD Form 9 is printed.This is checked by default.
ReSD Report Tabulations
Tabulations	If this is checked, all the tabulations in the section are checked and included in the print.This is checked by default.
Tabulation for Unlisted Events	When checked, this tabulation is included in the print.This is checked by default.
Tabulation for Listed Events	When checked, this tabulation is included in the print.This is checked by default.
Case Overview Tabulations	When checked, this tabulation is included in the print.This is checked by default.
Overdose Tabulation	When checked, this tabulation is included in the print.This is checked by default.
Accident Exposure Tabulation	When checked, this tabulation is included in the print.This is checked by default.

Additional Information

• Separate page numbering always follow the previous form of PSR and ReSD. The following is the order of the page numbering sequence:

  PSR Form 3, 4, 7, 7-2, ReSD Form 4, 5, and 789

• When you select PSR, ReSD using the radio button, the system selects all the forms available for each set of report automatically (PSR - above table 1, 7, 10, and 13) (ReSD - above table 15, 20, 23, 25, 27, and 29). By default, PSR is selected and PSR forms are selected.

• If the radio button is used to select the PSR form, the previously checked forms on the ReSD are unchecked. If the radio button is used to select the ReSD form, the previously checked forms on PSR are unchecked. While the PSR is selected, the ReSD section is disabled. While ReSD is selected, PSR section is disabled.

• If you close the configuration and opens again, the configuration on the UI remains as it was at the time of the last operation.

• All the forms format are based on the Novartis PSR form sample.

• You are not allowed to change the configuration parameters for PSR Form 3, 4 and ReSD Form 4, 5; if there are any past (non-editable) timeframe rows. If there are past timeframe rows in the scheduling frequency table, configuration of the PSR Form 3, 4 and ReSD form 4, 5 is non-editable.

• When you check the Print the report content as Case Listing in the separate paper, the Case Line Listing along with the report content is printed on a separate paper.

  • The Case Listing is printed only for the current timeframe for PSR form 3, ReSD Form 4 and PSR Form 7-2.

  • This line listing is independently printed (using separate page) regardless of the Configuration Printing check box status. If you checked the option to print out the configuration content and Case Listing, the Case Listing is appended after the configuration content.

  • The order of the print is Configuration > Form 3 Line Listing > Form 7-2 Line Listing > All the actual reports

  • The Case Line Listing report does not follow the Separate Page option. The Case Line listing is always separated and starting from page 1 for each form.

PSR Form 3 Case Line Listing

#	Field Name	Description
1	PSR/ReSD Case Line Listing	This field represents the section title.
2	Periodic Safety Report	This field represents the 2nd title.
3	Periodic Safety Report form #3	This field represents the title for Form 3 section.
4	Types of adverse event	The List of AEs are printed using exactly the same rule and order as that of the PSR Form 3.
5	Case Number	All the reported AE's case numbers are printed in this field. These case numbers are separated by comma.
6	Number of AEs reported during this timeframe	Number of the AEs available also on the PSR form 3 for this report's investigational timeframe.

PSR Form 7 Case Line Listing

#	Field Name	Description
1	PSR/ReSD Case Line Listing	This field represents the section title.
2	Non Serious, Unlisted Periodic Safety Report	This field represents the 2nd title.
3	List of non-serious, Unlisted adverse event	This field represents the title for Form 7-2 section.
4	(form 7 body)	This section is always same as the PSR form 7.
5	Case Number	The Argus case numbers are added using this field.

ReSD Form 4 Case Line Listing

#	Field Name	Description
1	PSR/ReSD Case Line Listing	This field represents the section title.
2	Re-examination submission dossier	This field represents the 2nd title.
3	ReSD Form #4	This field represents the title for Form 4 section.
4	Types of adverse event	List of AEs are printed using exactly the same rule and order as that of PSR Form 3
5	Case Number	All the reported AE's case numbers are printed in this field. These case numbers are separated by comma.
6	Number of AEs reported during this timeframe	Number of the AEs available also on the ReSD form 4 for this report's investigational timeframe.

4.2.7.2.4 Scheduling

Field Name	Description
Delivery quantity	This field represents the title of the section. This section displays the delivery quantity information for each timeframe row, when that row is clicked.
Clear All	When you click this button, all the entered information on this UI is cleared (The data entered by you only. For example, the Delivery Quantity and Delivery Unit for all the products in the Delivery Quantity section is removed but the product names remain in each row.When this is clicked, a confirmation window with the following message is displayed: If you continue, the entered information is erased. Do you want to continue?. The content in the UI is deleted when you enter OK.No actions are taken on the table if you select Cancel in the message window.
Products	Product names used in this PSR appear as default. The names can be changed only at first report generation. From second report, names are read-only unless they are newly added.The maximum text length is 70.
Delivery quantity during this period	This field represents the text entry for numbers.The maximum text length is 12 (including the decimal point and number). Only numeric character and decimal point are allowed.
Unit	Type ahead functionality with console J Unit (J). For the units data that does not have unit(J), if unit (J) is not available, the field is left blank.You can change the unit only at first report generation.
Total Amount	Text entry for number. Only when the entered units are the same, the calculated total from above is displayed in this field. Maximum text length is 15 (including the decimal point and number). Only numeric character and decimal point are allowed.
Entering the Delivery Quantity	Delivery quantity table is entered into the report only when this is checked. This is unchecked by default. If this is not checked, the Delivery section of the report is blank (unchecking does not delete the values in UI).

4.2.7.2.5 Security

4.2.7.2.6 Printing PSR / ReSD

Field Name	Description
Report Batch Printing
Run at	You can specify the time of Reporting using this field. The date entry is in Japanese.
Run Now	This field represents the Print now option.
Print As	You can select printing option from Final, Draft, Internal, or Other.
Other
Due Date	Automatically populate the calculated value by using the due days.

Generating the Document

Generation of the document is executed using the following process:

1. Click View Report in the Reports > Compliance > Periodic Reports.

2. Check-out the report from the View and edit PSR/ReSD pop-up.

3. Edit the checked-out word document

4. Check-in using the same View and edit PSR/ReSD pop-up.

5. Publish the PDF file (converting from the checked-in word doc)

Printing Requirements

• The system allows you to Print the Report and update the Report output in the Word document.

• The change of the configuration for the same investigation timeframe can be done multiple times only before the status is changed to Submitted. The changes in the configuration after the Submitted status of the PSR is applied on the next investigational time period.

• From the Reports > Compliance > Periodic Reports, selecting View Report allows you to View the PSR/ReSD Report in Word document to upload the report.

  • When the J user opens Reports > Compliance > Periodic Reports from the menu, the Japanese UI is displayed for Periodic report list. The pop-ups for the PSR View and Edit are Japanese.

    
    

    Field Name	Description
    Trade Name	The J UI displays available Japanese data. When Japanese data is not available, the English data is displayed.The Trade Name section displays the multiple trade names using comma separated list of the selected products.The Trade Name displays the original product selected: English or Japanese. If PSUR was created for the English product names, the English product name is used in the list. If the PSR is created with the Japanese product names, the Japanese product name is used in the list.If the selected product in the PSR does not have the Japanese Trade name, the English trade name is displayed for that PSR.
    Destination	The Japanese UI displays the available Japanese data. When Japanese data is not available, the English data is displayed.When Destination is not available, display No specific receiver.
    Description	The Japanese UI displays the available Japanese data. When Japanese data is not available, the English data is displayed.
    Due Date	English date format is DD-MMM-YYYY.Japanese date format is YYYY/MM/DD
    Status	Status appears in Japanese in the Japanese UI, and in English in English UI and can have the following possible values: Deleted Scheduled Generated Approved Disapproved Submitted New Data Available No Longer Required

    
    

• The report output is in Word Document. This works in the similar way as ePSUR publishing where you are allowed to edit the Word output outside the system and once generated, can publish the FINAL Word Document.

  • When the report is generated and never checked out, the center button display Check-out to let you revise the document. At this time, Publish button is disabled.

  • Check-out can be executed by one user only. Other users cannot check in the checked-out files.

  • Once the check-out is executed, the Check-out button is changed to the Check-in button. This button is used to check-in the revised checkout file.

  • When the file is checked-in, the center button is changes to the Check-out button.

  • When the file is not checked-out or not published, you can check-in/check-out the file as many times as you want.

  • When the file is not checked-out or not published, the group which has the access rights to this report can execute the check-in, check-out, and publish.

  • The View button is always enabled (regardless of the check in/check out status). It displays the latest updated Word document or the PDF after final Publish.

  • The Publish button is enabled after at least one time of the check-in action. The Publish button is disabled when the document is checked-out.

  • Once the final Word file is created, the Word document is saved in the repository. All the past PSR word output are saved. When you update the Word document and uploads it, the system overwrites the automatically generated document in the database.

  • Once the Publish button is executed and the PDF file is created, the Check-Out button is grayed out and disabled.

  • Once the document is checked-in, the Check-in button is changed to Check-out, and the Publish button is enabled to publish the PDF report from the Word document.

  • The Publish button converts the checked-in Word document to the PDF file.

  • Once Publish is done, the Word document is no longer available. The Check-in / Check-out button is disabled only when the PSR is published and the label is changed to Check-out.

    
    

• When the Check-in button is clicked, the following pop-up is displayed to specify the file name. This can be done by either specifying the file name in the text box, or selecting the location using the Browse button.

  
  

• If the data is changed manually in the Word document, this change is not applied to the next report. The report needs to be changed again.

• The configuration of the PSR/ReSD can be edited while the PSR is checked-out. The change is affected only when the PSR is created again.

4.2.7.2.7 Deleting PSR / ReSD

Click Yes in the prompt shown below to delete the PSR/ReSD report.

4.2.8.1 Format

The system allows configure and output J-DSUR defined by the PMDA for products. The purpose is to define a fixed set of J-DSUR for PRIMARY AGENCY (the various regulatory authorities as optional) and then associate products/studies with these reports. The J-DSUR can then be scheduled automatically.The J-DSUR applies only for Japanese licenses.Argus J is capable of output J-DSUR Form 1 and Form 2.

• The system contains a configuration screen to define a J-DSUR report. A new menu item, Reports > Periodic Reports > J-DSUR ) has been created. When this is clicked, the following page is displayed.

  
  

  J-DSUR Main Window

• If the report is being currently opened by another user for modification, the system displays the following message:
  The report which is selected is being used by XXXX and cannot be modified.
  where XXX is the full user name of the user who has it opened.

• The Create from Template button that is available on Argus E PSUR and CTPR section, is not added for Japanese PSR, J-DSUR configuration.

• This page displays a list of the CSPSR/J-DSUR reports stored in the system.

  • You can add a new report by clicking the New Report button.

  • The Copy button creates a copy of an existing report.

    When you copy an existing CSPSR Report, all the configuration of the report including timeframe rows are also copied, and the CSPSR report gets converted to J-DSUR.

    When you copy an existing J-DSUR Report, all the configuration of the report including timeframe rows are also copied.

    The Report Name of the new copy has Copy of in front of the name.

    When the configuration of already Submitted report is copied, the past dates in the schedule frequency, CSPSD, and Assigned Date are also copied as read-only. Other sections of the copied configuration are editable.

    When you copy an existing non-submitted J-DSUR report, all the configuration including timeframe rows is also copied. As the original report was non-submitted, all the timeframe rows are retained as non-editable or editable as they were in the original J-DSUR.

  • The Modify button displays the report definition.

  • The Delete button allows you to delete a report after displaying the following confirmation message:
    Proceeding to Yes will remove the report configuration. Proceed?.

  • Clicking Print results in displaying a new dialog box prior to Report Preview allowing you to select from several preview or direct export options: Word output.

• The Delete option is only available if there are no Final Reports generated for the Periodic Reports. In any case, the Delete option only hides the report from the list.

• The generated last executed report is available from a link that fetches the report from the database.

• Clicking New or Modify displays the J-DSUR Configuration Window.

• Once the state of the report is changed to Submitted, you are not able to update the configuration of that J-DSUR. This is achieved by disabling the OK button. For example, when the state is un-submitted, the report is editable again. In addition, when the non-editable configuration is opened, the following warning message is displayed:
  This configuration is not modifiable because the status of this J-DSUR is Submitted.
  When you click OK, the Configuration window is displayed. When you click Cancel, the Configuration window is not displayed.

• When the status of the report is Submitted, only the Configuration page is printed.

• Copy can be done any time while the configuration exists.

  When you create J-DSUR after the second time, the new copy of the configuration is required. You can then modify the content to print the current J-DSUR.

• Before saving the J-DSUR configuration, Report Name, Primary Agency, Product Selection, and at least one timeframe need to have a value entered.

  Else, the following error messages are displayed:
  
  When Report Name is not entered:

  Report Name is not entered

  When Primary Agency is not entered:

  Primary Agency is not entered

  When selected product is not available:

  Product is not selected

  When atleast one time frame is not entered:

  Investigation time frame is not configured

  When Assigned Date is not entered:

  Assigned Date is not entered.

  Following message is displayed along with the above error:

  It is necessary to enter above information in order to save the configuration

• When the Modify, Copy, Delete, or Print button is clicked without a selection of report, a pop-up is displayed to select a report.

• If any one Submitted report is present, the Report Configuration is non-editable even if it has multiple generated reports with different states.

• If you print an existing CSPSR report, it displays only the configuration details.

4.2.8.2 J-DSUR Details

4.2.8.2.1 Subject of Report

Field Name	Description
Report Name	Manually Input a name for the report that is displayed in the Reports > CSPSR Reports dialog box.
Report Category	Manually Input a name for a Report Category that is displayed in the Reports > CSPSR Reports dialog box.
Primary Report Agency	This list contains the Regulatory Authorities configured in List Maintenance > Regulatory Authorities (LM_REGULATORY_CONTACT table). If there is no Japanese Authority name configured, the English name is listed. The system allows you to select multiple agencies from the List of Agencies so that the report can be submitted to multiple agencies at the same time.The primary agency can be defined in this drop-down list.When Japanese Message Profile is not configured in Console J for the selected Primary Agency, the following error message is displayed: Selected Primary Agency doesn't have configured Message Profile (I or J) in Argus Console/Reporting Destination/EDI. Once you click OK, the selection of the Primary Agency goes back to the previous selection. This check is executed when you try to go to the other tab, or click OK to save the configuration.
Report Number	Manual entry text field that allows you to enter a report number.
Print all configuration criteria on separate cover page	This field represents the check box to print the configuration of this report when the report is printed. When this is clicked, the Configuration page is printed at the beginning of the CSPSR Word print output. The page numbering of the CSPSR does not include the Configuration page.

If the Japanese Agency Name is not configured in the Console, the English name is displayed on the screen for that agency.

4.2.8.2.2 Product Selection

Field Name	Description
Available Ingredients	The system allows filtering the Ingredients within the available list of Ingredients by entering the Ingredient Name and clicking the Filter button.The search is performed in Japanese ingredient name only. If the name is blank, then enter English ingredient name.
Indication	This list contains the Indication configured for the product containing the ingredient in C5 section. Use this to narrow down the products displayed in C8.The system allows to multi-select Indications using standard Windows functionality of CTRL+CLICK.If Japanese name is not available, display the English name
Available Products	This list is auto-populated once the Ingredient has been selected and displays all products from LM_PRODUCT J table, containing the ingredient selected in C5 section. The format is Product name (Formulation, Concentration concatenated with the Concentration Units). If the Japanese name is not available, the English name is displayed. The withdrawn products are displayed as well.
Selected Ingredients	This list contains the Ingredients used for the Products Configuration. It is stored in the LM_PF_INGREDIENT_J table once a product has been configured. When an ingredient has been selected, all products containing that ingredient are displayed in Available products (C8) section. Multiple Ingredients can be selected at once to form a CSPSR product family.
Formulation	This list contains the formulation configured for the product using the ingredient in C5 section (LM_FORMULATION table). Use this to narrow down the products displayed in C8.The system allows to multi-select formulations using standard Windows functionality of CTRL+CLICK.If Japanese name is not available, the English name is displayed.
Selected Products	This list contains products that are selected from the Available Products list (C8). When at least one product is selected, the field has a blue background color. If the license is not withdrawn at the starting date of the J-DSUR investigation timeframe, include the license in J-DSUR. Data Entry Discipline: When the new product is available because the new product with the same ingredient released in the J-DSUR, you need to manually set up the new configuration. When no Japanese ingredients, indication, or formulation is configured in the Console, the English names are displayed.When you copy an existing submitted J-DSUR report, the Assigned dates remain editable. In such a scenario, if you change the product selection, the Assigned dates do not change. All the forms printed as J-DSUR have only the information regarding the selected product in this Configuration window.When a product is moved to Selected Products field, but this does not have the Clinical Compound Number, the following error message is displayed: Selected product doesn't have a Clinical Compound Number. It is necessary that the study product license has at least one Clinical Compound Number in order to include in the report. If License # as well as Clinical Compound Number is not available, then for J users, if Trade Name (J) is available then it will display <License Authorization Country> (<License Type>) <Trade Name (J) from Console J>. Else <License Authorization Country> (<License Type>) <Trade Name from Console> is displayed.
Available Studies	Lists the available studies.
Selected Studies	Lists the selected studies.

Available/Selected Studies multi-select shuttle controls

• Available Studies field dynamically lists all the company configured studies in Console, which consists of the selected J-DSUR products. The Study ID (J) value from Console > Study Configuration must be listed.

• These 2 shuttle controls have Add, Add All, Remove, and Remove All buttons to Select/Remove studies between Available and Selected Studies fields.

• If any product is added/removed from the Selected Product field, the Available and Selected Studies fields are also updated dynamically.

• The Selected Studies field is displayed in blue background, same as that of the Selected Products fields.

• If Selected Studies fields do not contain any study, clicking on OK button displays the following error message and brings the focus back on the Selected Studies field:

  At least one domestic study must be selected in order to proceed with the configuration.

4.2.8.2.3 J-DSUR

#	Field Name	Description
1	Forms configuration	This field represents the main title of the UI.
2	J-DSUR	This field represents the title of the set of configuration forms.
	J-DSUR Form 1
3	Report form - Clinical Trial Safety Update Report Overview	This field represents the title of the form to be configured.
4	Print Blank Form	This checkbox is used to print the blank form.
	J-DSUR Form 2
5	Report form - Serious AE Case Occurrence Status Listing	This field represents the title of the form to be configured.
6	Number of subject: Study__	This is a manual data entry (Numeric only) field. You can enter total number of subject for this entire clinical study for domestic.The Maximum digits for this number is 7 for both fields.
7	Order SOC Alphabetically (Check box)	If this is checked, the SOC is printed in alphabetical order (alphabetically based on their English names). If not checked, the SOC order is same as that of the MedDRA order.
8	Include foreign AE marked as "Not include for the report in Japan" (Check box)	When this is checked, the system includes AEs in the foreign cases that have flags for Not include for the report in Japan (available in the Case Form > Event tab)
9	Use Current Case VersionUse DLP Case Version	This radio button control is only displayed if DLP is enabled. Use Current Case Version is selected by default.Based on the J-DSUR configuration for DLP, the report is executed accordingly using latest case revision or using the DLP case revision.
10	Separate Page Numbering (Check box) Note: When separate page numbering is not used, it always follows the previous form of J-DSUR. Order of the page numbering sequence is following: J-DSUR Form Cover, Line Listing	When this is checked, the page number becomes independent (starts from 1) for J-DSUR Line Listing.
11	Print the content of the report as case listing on separate page	If this is checked, Case Listing of the J-DSUR Line Listing content is printed on a separate page. Note: The Case Listing is printed after the configuration content, and using following style guide template for listing.
12	OK
13	Cancel

StyleGuide_CaseList.doc

#	Field Name	Description
1	Periodic Safety Report - Case Line List	Static text
2	Clinical Study Serious Event Case Periodic Report	Static text
3	Serious AE, etc. Case Occurrence Status Line Listing	Static text
4	AE, etc. Case classification	Static text
5	AE, etc. Case Count	Static text
6	This investigation period	This column has the same output as the printed J-DSUR
7	Cumulative Total	This column has the same output as the printed J-DSUR
8	Case Number	Case Numbers that have counted events are listed with the comma used as a separator.
9	Clinical Study	Static text. This section only considers the cases, which contain the studies configured as Selected Studies in the Product Selection tab.
10	SOC	This field has the same output as the printed J-DSUR.The Case Listing is not printed for this section.
11	Event sectopm	This field has the same output as the printed J-DSUR.The Case listing is printed for this section.
12	This investigation time frame: YYYY?MM?DD????YYYY?MM?DD? - TBD	This field has the same output as the printed J-DSUR.
13	Terms for AE: MedDRA/J version ( ) was used.	This field has the same output as the printed J-DSUR.

4.2.8.2.4 Scheduling

Field Name	Description
Clinical Study Plan Submit Date	This is a manual data entry text field. It is an editable text field. If OK is clicked, the new value remains in the field. If Cancel is clicked, the original value is replaced with the entered value in the field.CSPSD is an editable field, if the J-DSUR is not in Submitted state and it does not have any previous non-editable timeframes.Once a J-DSUR is marked as Submitted, this field becomes non-editable.
Report is due ___days after specified end date	This option allows you to specify the due date of the J-DSUR, xx days after the end date specified for the scheduling period. The value entered in this field is added to the current end date and displayed in the printing UI as due date.
Group	This option allows you to specify which Argus group is responsible for the Periodic report, once scheduled by the application. The report appears on the designated group's worklist for Reports.
Frequency of the schedule
Start Date	This field is a date entry field for the reporting timeframe starting period. It allows you to enter the starting date of each J-DSUR timeframe starting period. The first Report Timeframe Start Date is auto-calculated as per the Assigned Date. The Start Date for the first timeframe is editable till the report is submitted. Start Date of the new row always has the next date of the previous End Date pre-populated as read-only, and End Date can be added only one at a time.The Start Date of the J-DSUR is auto-populated and reset as per the Assigned Date value, only if the first timeframe row (first start as well as end date) is editable. The Start Date of the J-DSUR is not updated based on the Assigned date, if this first timeframe row is non-editable.Whenever Start Date is auto-updated and end date is already specified, the system displays the following warning message: Start Date for the reporting period has changed. Please update the End Date accordingly.When you enter the Start Date which is older than the latest End Date (previous row), the system displays the following error message: Start Date must be same day, or after the latest end date. By clicking OK, the wrong Start Date is removed. Note: The J-DSUR contains the number of events from Submitted to the Japanese Agencies and non-reportable events within the Reporting Period.
End Date	This field is a date entry field for the reporting timeframe ending period. It allows you to enter the ending date of each J-DSUR timeframe starting period. This is an editable field.When you enter the End Date which is earlier than the same timeframe's Start Date, the system displays the following error message: End date must be after the Start Date By clicking OK, the wrong end date is removed. Note: The J-DSUR contains the number of events from Submitted to the Japanese Agencies and non-reportable events within the Reporting Period.The System does not allow you to edit the previous reporting period and only allows to edit the current reporting period.
Add	You can add editable row by clicking this button. You can add only 1 reporting timeframe which can remain in Editable state in a J-DSUR in single configuration. All the previous reporting timeframes are always in non-editable state.By default, in a freshly configured J-DSUR (non-submitted, non-copied), there is no timeframe row to begin with until you add one row using the Add button.Whenever the first timeframe row is added, the Start Date is auto-populated based on the Assigned Date.When you generate a J-DSUR, it is generated based on the last editable timeframe row.Once the report is marked with the Submitted status, all the timeframe rows are marked as Non-editable.If you do not have any editable timeframe row available in the J-DSUR, only then Add button is enabled. Else, it is always disabled.The Add button adds editable fields for Start and End date. Each row has a number that starts from 1 and is incremented for each timeframe.
Delete	You can delete the editable row by clicking this button. The Delete button cannot delete the non-editable row. For removing previous non-editable rows, you can use the RESET button. This makes sure that you do not delete any timeframe rows which J-DSUR has already submitted. When this is selected, the following warning message is displayed to confirm the operation: Would you like to delete the highlighted row?
Reset	When this button is clicked, all the existing timeframe rows (editable as well as non-editable) are deleted. Else, the past Start and End date records are non-editable. When the Reset button is clicked, the following warning message is displayed: By using Reset, all the past data will be removed. Do you want to proceed? If you click OK, proceed with the reset. If you select Cancel, leave the past data in the schedule table.When you make copy of a configuration, the Assigned Date, CSPSD, and CTPCSD are non editable unless the Reset button is used.

4.2.8.2.5 Security

4.2.8.2.6 Printing CSPSR

Generating the Document

The generation of the document is executed using the following process:

1. Click View Report in Reports > Compliance > Periodic Reports

2. Check-out the report from the View and edit J-DSUR pop-up.

3. Edit the checked-out Word document

4. Check-in using the same View and edit J-DSUR pop-up

5. Publish the PDF file (converting from the Checked-in Word document)

Printing Requirements

• The system allows you to print the report and update the report output in the Word document. The watermark is printed on the report when the Draft, Internal or <Other> is selected for printing.

• The change of the configuration for the same investigation timeframe can be done multiple times only before the status is changed to Submitted. The changes in the configuration after the Submitted status of the J-DSUR is applied on the next investigational time period.

• From the Reports > Compliance > Periodic Reports, selecting View Report allows you to view the J-DSUR Report in the Word document to upload the report.

  • When J user opens Reports > Compliance > Periodic Reports from the menu, Japanese UI is displayed for Periodic report list. The pop-up for the J-DSUR view and edit is in Japanese.

    
    

    #	Field Name	Description
    1	PERIODIC REPORTS	Lists the Periodic Reports.
    2	View All	Enables you to view all the reports.
    6	Trade Name	The Japanese UI displays available Japanese data in this field. When Japanese data is not available, the English data is displayed.
    7	Destination	The Japanese UI displays available Japanese data. When Japanese data is not available, the English data is displayed.When Destination is not available, No Specific Receiver is displayed.
    8	Description	The Japanese UI displays available Japanese data in this field. When Japanese data is not available, the English data is displayed.
    9	Due Date	The English date format is DD-MMM-YYYY.The Japanese date format is YYYY/MM/DD.
    10	Status	The Status appears in Japanese in Japanese UI, and in English in English UI and can have the following possible values: Scheduled Generated Approved Disapproved Submitted New Data Available No Longer Required

    
    

  • Trade Name section:

    The Trade Name section displays the multiple trade names using comma separated list of the selected products.

    The Trade Name displays the original product selected: either English or Japanese. If PSUR was created for the English product names, the English product name is used in the list. If the J-DSUR is created with Japanese product names, the Japanese product name is used in the list.

    If the selected product in the J-DSUR does not have the Japanese Trade Name, the English Trade Name is displayed for that J-DSUR.

• The report output is a Word Document. This works in the similar way to ePSUR publishing where you are allowed to edit the Word Output outside the system and once generated, can publish the FINAL Word Document.

  • When the report is generated and it has been never checked out, the center button displays Check-out to revise the document. At this time, the Publish button is disabled.

  • Check-out can be executed by one user only. Other users cannot check-in the checked-out files.

  • Once the check-out is executed, the Check-out button is changed to the Check-in button. This button is used to check- in the revised checkout file.

  • When the file is checked-in, the center button becomes the Check-out button.

  • When the file is not checked-out or not published, you can check-in/check-out the file as many times you want.

  • When the file is not checked-out or not published, the group which has access rights to this report can execute the Check-in, Check-out, and Publish.

  • The View button is always enabled (regardless of the Check-in/Check-out status). It displays the latest updated Word document or the PDF after final Publish.

  • The Publish button is enabled after the check-in has been performed atleast once. The Publish button is disabled when the document is checked-out.

  • Once the final Word file is created, the Word document is saved in the repository. All the past J-DSUR Word outputs are saved. When you update the Word document and upload it, the system overwrites the automatically generated document in the database.

  • Once the Publish button is executed and the PDF file is created, the Check-Out button is disabled.

  • Once the document has been checked-in, the Check-in button is changed to Check-out, and the Publish button is enabled to publish the PDF report from the Word document.

  • The Publish button converts the checked-in word document to the PDF file.

  • Once Publish is done, the Word document is no longer available. The Check-in/Check-out buttons are disabled only when the J-DSUR is published and the label is changed to Check-out.

    
    

• When the Check-in button is clicked, the following pop-up is displayed to specify the file name. This can be done by either specifying the file name in the text box, or selecting the location using the Browse button.

  
  

• If the data is changed manually in the Word document, this change is not applied to the next report. You need to change the report again.

• The configuration of the J-DSUR can be edited while the J-DSUR is checked-out. The change is affected only when the J-DSUR is created again.

4.2.8.2.7 Deleting A J-DSUR

Click Yes on this dialog box to delete the report configuration.

Click No to exit without deleting.

4.2.8.3 J-DSUR - Cover

Summary: The J-DSUR Cover is the cover page of the J-DSUR Line Listing, and output includes the information of the configured product. This form does not contain any particular case data.

Additional Information

• This cover page has Japanese license information only.

• If all the information is the same through all the numbered items, enter the numbers with one information. When there is no data available, skip the data and only print the serial numbers for which the values are present.

• If the license is withdrawn before the Start Date of the J-DSUR time frame, all the product information as well as the license information is not displayed.

• The overflow data is printed on the next page on the copy of this cover page that does not have any data other than the overflow data.

• For Ingredient Name, Indication, Study Development Phase, Amount, and Formulation, if source console values are not configured, fields on the paper form are left blank.

4.2.8.4 J-DSUR - Form 2

Summary: J-DSUR - Form 2 is the report of events that are serious (both Reported and Not Reported) during the specified investigational time period for Study drugs (including Study for partial change of the Marketed drugs).

• The past record is included in the report as cumulative Total Number of SOC and Terms.

• The number of the serious events which are either Reported or Not Reported to the PMDA within one investigational timeframe is the content for the report.

• Regardless of Incomplete or Complete report, all the events during the investigational timeframe are listed.

• If there are multiple events in one case, count each Reportable event separately. For example, if there are 2 same PTs available in the same case, the count is 1 SOC and 2 PTs.

• A case is included in the report for the current timeframe only if a significant Japanese follow-up is received for the case in the same timeframe. If there are no significant updates for the case, this case is not counted for the current period.

• If there are multiple follow-up updates (Significant or Non-significant) to a qualifying case in the same investigational time frame, count the events based on latest information on the events in the case and exclude the Deleted events during the timeframe. If the event is entered as Serious, but later in the same timeframe, this is changed as Non Serious, this event is not counted.

• The MedDRA version is the latest MedDRA J version at the time of report creation.

• The configured products that fall in DRUGCHARACTERIZATION = 1 (SUSPECTED) or 3 (INTERACTION) are collected. 2 (Concomitant) is not included.

• The date cut off for the data inclusion is based on the case's Japan first information Aware Date (in PMDA > General tab of the Case Form). If this is a follow-up case, the Aware (latest significant follow-up) Date.

• The Serious events must be Related events to be included in the list.

• An event which is included in the past J-DSUR report is included in the Cumulative Total section of the count in the report.

• For identifying the Japanese license, the license authorization country in the license configuration in Console is used. For the count of the foreign data, all configured products that have the same ingredients (regardless of the existence of Japanese license in this family) is considered as the target.

• When the End Date is set as past date, any updates/new data that meet above condition in between the End Date and the current date are not included in this line listings. The data is the latest in the given timeframe, and not between the investigational timeframe Start Date and the Report Generation Date. This is achieved when you have enabled DLP and has configured the Use DLP Case Version radio option for J-DSUR configuration.

• If there is 0 count on any counting numbering sections of the Line Listing, - is printed.

• From 2nd and subsequent pages, the table header rows are repeated at the top of the each page.

Basic Data Retrieval Rule:

Cumulative Total:

• In J-DSUR, the Cumulative Total is the count of Serious AEs that are collected between the Assigned Date and the end of the current investigation timeframe.

Investigation Time Frame

The Serious AEs from the cases collected in this investigation timeframe from among the cases retrieved by Cumulative Total.

4.2.8.4.1 Domestic Serious AE, etc. Case Occurence Status Line Listing

Field Name	Description
Serious AE, etc. Case Occurrence Status Line Listing	This field represents the title of the paper form.
Attached paper form	This field represents the header of the paper form.
Information Source	This field represents the title of the row.
Clinical Study	This field represents the title of the column. This column has data only from the report source: Clinical study and Incident Country = Japan. It only considers the cases which contain the studies configured as Selected Studies in the Product Selection tab.
Investigation Time Frame	This field represents the title of the row.
This investigation period	This field represents the title of the column. This column collects count information in this investigation period only.
Cumulative Total	This field represents the title of the column. This column collects total number of count information in the entire reporting period starting from the first Assigned Date to the end of current investigation period.If the configuration is set (checked for Exclude the event count from the cumulative total if the event doesn't meet the condition), events that were reported in the past but as the condition has been modified in the current timeframe they no longer meet the condition, are removed.
This investigation period	This field represents the title of the column. This column collects count information in this investigation period only.
Cumulative Total	This field represents the title of the column. This column collects the total number of count information in the entire reporting period starting from the first Assigned Date to the end of current investigation period.
This investigation period	This field represents the title of the column. This column collects count information in this investigation period only.
Cumulative Total	This field represents the title of the column. This column collects the total number of count information in the entire reporting period starting from the first Assigned Date to the end of current investigation period.
Number of subjects	This information is captured from the J-DSUR tab.
AE, etc Case classification	This field represents the title of the column.
AE, etc. Case Count	This field represents the title of the column.
SOC name in Japanese	The SOC count is the count of cases (not AEs). The number is collected for this inv. Period and the total of entire J-DSUR time.
PT names	All the serious AEs are counted and entered for this inv. Period and entire J-DSUR time.
This investigation time frame: YYYY/MM/DD	This investigation timeframe is entered using the Japanese date format.
Terms for AE: MedDRA/J version ( ) was used.	The used MedDRA/J version must be entered in the brackets.

4.2.9.1 Configuration Screen

• A new menu item - Individual Report Common Line List is added in Console > Groups > Menus section for the Argus Groups for Seiyakukyo report.

  • It is added under Reports > Periodic Reports right after J-DSUR menu option.

  • It is marked enabled by default for Administrator Group.

  • It is marked enabled by default during New Argus group creation.

  • It is only displayed if Console > System Management > Enabled Modules > Japanese module is enabled.

  • The following options are available

    • Include listed and unlisted events

    • Include unlisted events only (default option)

      
      Description of the illustration ''fig7.jpg''
      
      

• A new menu item - Individual Report Common Line List is added under Argus Safety > Reports > Periodic Reports menu.

  • It is added under Reports > Periodic Reports right after the CSPSR menu option.

  • This menu item is only available in Argus Safety if following conditions are met:

    Console > Access Management > Users > User Type of the current user is configured as ARGUS J USER.

    Console > System Management > Enabled Modules > Japanese module is enabled.

    Console > Access Management > Groups > Menus section for Argus Groups has Reports > Individual Report Common Line List marked Enabled for at least one user groups for the current user.

• Clicking on this menu in Argus Safety displays the existing Periodic Reports Library screen, which lists all the configured Seiyakukyo reports available in the system.

  • The functionality of this screen remains the same as existing except for the following:

    The page breadcrumb for the Periodic Reports Library screen for Seiyakukyo is displayed as:
    Reports > Periodic Reports > Serious, Unlisted AE Individual Case Communication Line List

    The screen name for this screen is displayed as Serious, Unlisted AE Individual Case Communication Line List.

    When you click the Open button for a submitted Seiyakukyo report whose configurable becomes non-editable, the following warning message is displayed:
    This configuration is not modifiable because the status of this Individual Case Communication Line List is Submitted

• Clicking New or Open buttons on Periodic Report Library screen for Seiyakukyo reports displays the Configuration screen for Seiyakukyo reports which has 5 tabs similar to the CSPSR Configuration screen with following names. The Page Title text is: Individual Report Common Line List.

  • Subject of Report

  • Individual Report Common Line List

  • Scheduling

  • Security

• The Subject of the Report tab is the same as the existing Subject of the Report tab for CSPSR.

  
  

• The Study Selection tab has the following functionality:

  
  

  Field Name	Description
  Filter	This button is available adjacent to the Available Clinical Compound Numbers textbox to allow filtering the data in the Available Clinical Compound Numbers multi-select list box.When you click this button, the data is refreshed in the Available Clinical Compound Numbers multi-select list box based on the search text specified by you in the textbox.Like search is performed based on the text specified by you. For example, If you have specified ABC as the search text, it performs case-insensitive text for %ABC%.The maximum allowed length of the Filter textbox is 70 characters.
  Available Clinical Compound Numbers	It lists distinct Clinical Compound Numbers for all the licenses which are configured in the Console application.
  Selected Clinical Compound Numbers	This listbox is populated based on your selection and removal of Clinical Compound Numbers by using Add and Remove buttons from/to the Available Clinical Compounds listbox. This is a mandatory field. If it is not specified, and the OK button is clicked, the following error message is displayed: Clinical Compound Number is not selected
  Add	This field allows you to move the selected item(s) from left hand listbox to the right hand listbox.
  Add All	This field allows you to move all the items from the left hand listbox to the right hand listbox.
  Remove All	This field allows you to move all the items from the right hand listbox to the left hand listbox.
  Remove	This field allows you to move the selected item(s) from the right hand listbox to the left hand listbox.
  Classifications for Clinical and Domestic Study Cases	It lists all the Case Classification (J) values from the Console code list. If J is not available, the corresponding English value is displayed. You can select multiple values in this listbox by using Ctrl + Click and Shift + Click combinations. The first option in this list is always displayed as: All Case Classifications These case classifications are used for fetching the case data for Clinical and Domestic study cases reporting in Seiyakukyo report.
  Classifications for Foreign "Ichihen" Study Cases	It lists all the Case Classification (J) value from the Console code list. If J is not available, the corresponding English value is displayed. You can select multiple values in this listbox by using Ctrl + Click and Shift + Click combinations. The first option in this list is always displayed as: All Case Classifications These case classifications are used for fetching the case data for Foreign Ichihen study cases reporting in Seiyakukyo report.

  
  

• Seiyakukyo Report tab has the following functionality:

  
  

  #	Field Name	Description
  1	Individual Report Common Line List	N/A
  2	Common Configuration	N/A
  3	Company Name or Company abbreviation	You can specify the value of the Company Name to be printed in the second column of Seiyakukyo report using this field. The maximum allowed length of this textbox is 60 characters. It allows English as well as Japanese characters.
  4	Section Footer Text	You can specify a text to be printed as footer text at the end of each section in the report output using this field. The maximum allowed length for this textbox is 200 characters. It allows English as well as Japanese characters.
  5	Available Additional Columns (CSV Only)	This field lists all the available additional fields that can be added to the Seiyakukyo report CSV output. These are not applicable to the Word output. The following fields are available in this list in the alphabetical order: ACK Number Blinded / Not Blinded Determined Causality Event Intensity Japan Information Receipt Date LLT MedDRA Version Number of times this report is submitted to PMDA Primary Disease Reported Causality Report Submission Date SOC Study Name
  6	Selected Additional Columns (CSV Only)	It lists all the selected additional fields that are added to the Seiyakukyo report CSV output. These are not applicable to the Word output. You can move items between Available and Selected Additional Columns using the Add and Remove buttons. While adding items, these items are listed in the same order in which they are added. You can move items up and down using Up and Down buttons. The Seiyakukyo report output includes these columns at the end in the same order as specified in this list.
  7	Add	This field allows you to move the selected item(s) from the left hand listbox to the right hand listbox.
  8	Remove	This field allows you to move the selected item(s) from the right hand listbox to the left hand listbox.
  9	Up ^	This field allows you to move the selected item in the Selected Additional Columns, one position closer to top of the list.
  10	Down V	This field allows you to move the selected item in the Selected Additional Columns, one position closer to the bottom of the list.
  11	Clinical and Domestic Study Cases	N/A
  12	Exclude events which were reported by paper report forms	If this checkbox is checked, all the events which are reported through paper reports are excluded. This logic is applicable only for Clinical and Domestic Study cases for which events are reported based on Expedited/E2B reports. It is unchecked by default.
  13	Exclude Incompletion reports	If this checkbox is checked, all the events which are reported through Expedited/E2B reports where the value of J.6 (Mhlwadmicsrcompleteclass) = 1 (Incomplete) are excluded. This logic is applicable only for Clinical and Domestic Study cases for which events are reported based on Expedited/E2B reports. It is unchecked by default.
  14	Include listed and unlisted events (new)	You can specify the criteria for printing the events under Regular and Domestic Study cases category using this field. This radio button is selected by default if the "Include only serious unlisted event" checkbox was not selected for the already configured reports.
  15	Include unlisted events only (new)	You can specify the criteria for printing the events under Regular and Domestic Study cases category using this field. This radio button is selected by default: For all new reports. If the "Include only serious unlisted event" checkbox was selected for the already configured reports.
  16	Foreign "Ichihen" Study Cases	N/A
  17	Include foreign AE marked as "Not include for the report in Japan"	If this checkbox is checked, all the events in the cases which are marked as Not to be reported to Japan in the Case Form Events tab are also included. This logic is applicable only for Foreign Ichihen study cases for which events are reported based on case data directly. It is unchecked by default.
  18	Append CIOMS reports	If this checkbox is checked, the CIOMS reports are created and added at the end of Seiyakukyo report output for all the cases which are printed under Foreign Ichihen Study Cases section.These CIOMS report are printed for the earliest Valid Japanese license for the first suspected product in the case. If the first suspected product does not have a Valid Japanese license, the next suspected product which satisfies this criterion is picked-up in the same order in which they are present in the case. Once the Seiyakukyo is generated as FINAL, these reports are listed in the Case under the Regulatory Reports tab in the similar manner as for English PSUR.These reports are added only in the PDF format (not in CSV), when the Seiyakukyo report is published.These reports are generated at the time of Seiyakukyo generation. The Generation Status dialog box displays the label Generating CIOMS reports for this task during the Seiyakukyo generation process. Although, generated at this stage, these CIOMS reports are visible to users after the Word format is published into PDF format.Even if you modify the Events/Cases printed in the application generated Word/CSV formats of Seiyakukyo report, the application still prints the CIOMS reports based on the application generated case list under Foreign Ichihen Study Cases section.It is unchecked by default.
  19	DLP support	It displays 2 options to allow support of DLP for fetching case data for Foreign Ichihen study case: Use Current Case Version and Use DLP Case Version. This radio button control is only displayed if DLP is enabled. Based on the PSR/CSPSR configuration for DLP, the report is executed accordingly using the latest Case Revision or using the DLP Case Revision. Use Current Case Version is always checked by default.

  
  

• The Scheduling tab is the same as the existing Scheduling tab for CSPSR, except for the following:

  • The following date fields are not displayed as they are not applicable to the Seiyakukyo reports. All the validation checks related to these fields are also not applicable to the Seiyakukyo reports:

    Assigned Date

    Clinical Study Plan Submit Date

    Clinical Trial for Partial Change Plan Submit Date

  • The Start Date of first timeframe is editable as long as this timeframe is not submitted. However, the Start Date of second timeframes and onwards keep following the existing logic of being disabled and pre-populated as next day of the previous timeframe End Date.

    
    

• The Security tab is the same as the existing Scheduling tab for CSPSR:

  
  

4.2.9.2 Report Output Format

• This report prints information from two types of study cases:

  • Clinical and Domestic Study Cases

  • Foreign Ichihen Study Cases

• The report output prints the events from these 2 types as 2 separate sections starting from new pages.

• Within each of these 2 types, the report output prints the events for each of the configured Clinical Compound Numbers starting from new pages as well.

4.2.9.3 Report Output Filter Criterion

• Regular (Clinical) and Domestic Study Cases - All the data is fetched based on the events reported in the Expedited/E2B reports already reported to PMDA.

  • Only the Expedited/E2B reports sent to the reporting destinations which are configured as the Seiyakukyo Configuration > Subject of Report tab > Primary Agency are considered.

  • Only the Expedited/E2B reports whose cases have at least one of their Case Classifications configured as Seiyakukyo Configuration > Study Selection tab > Selected Classifications for Regular and Domestic Study Cases are considered.

  • Only the Expedited/E2B reports that have J.11 (mhlwcompoundnum) element value same as one of the values configured as Seiyakukyo Configuration > Study Selection tab > Selected Clinical Compound Numbers are considered.

  • Only the Expedited/E2B reports that have J.4a (mhlwadmicsrcasenumclass) element value as 8, 9, 10, and 11 (reporting categories - H, I, J, and K) are considered.

  • All Nullification and Downgrade reports are ignored. However, their Initial and Follow-up reports that fall within the Seiyakukyo current timeframe are still considered.

  • If multiple Initial or Follow-up Expedited/E2B reports for any product license (any series of Expedited/E2B reports) fall within the current timeframe, all of them are considered.

  • Only the Expedited/E2B reports that have Report Submission Date (GMT) between and including the Start and End date (after conversion to GMT based on database time zone offset) configured for the current timeframe of the Seiyakukyo report are considered.

  • If the radio option to include Unlisted events only is configures, it includes only those reported events from the Expedited/E2B reports that are unlisted in the case.

    Unlisted - Specified as Unlisted in the case against atleast one Japanese Investigational license (License Drug Authorization Country as Japan) having same clinical compound number as configured in Seiyakukyo report. The Listedness specified as Unknown is not considered.

  • If the radio option to include Listed and Unlisted events is configures, it includes all the reported events (listed and unlisted both).

  • If the checkbox to exclude incompletion reports is checked on the Individual Report Common Line List configuration tab, any Expedited/E2B report that have J.6 (Mhlwadmicsrcompleteclass) element value as 1 (Incomplete) is ignored.

  • If the checkbox to exclude Paper reports is checked on Individual Report Common Line List Configuration tab, all PMDA Paper Expedited reports are ignored.

  • If the same AE/Infection event is reported in multiple eligible reports from the same case, all of them are reported multiple times in the Seiyakukyo report as well.

  • All the events in Seiyakukyo report for Regular (Clinical) and Domestic Study Cases are sorted in the following order:

    • Case ID Number (ascending)

    • Report Submission Date (Old to New)

    • Events as ordered in the expedited/E2B report

• Foreign Ichihen Study Cases - All the data is fetched based on the events present in the case data.

  • Only the cases that have Country of Incidence other than Japan are considered.

  • Only the cases that have at least one of their Case Classifications configured as Seiyakukyo Configuration > Study Selection tab > Selected Classifications for Foreign Ichihen Study Cases are considered.

  • Only the cases that have atleast one of their Japan Information Receipt Date (significant follow-up or initial receipt date) between and including the Start and End date configured for the current timeframe of the Seiyakukyo report are considered.

  • Only the cases that have one of their Japanese licenses as present in the Case Form > Event Assessment tab and have the same Clinical Compound Number configured as Seiyakukyo configuration > Study Selection tab > Selected Clinical Compound Numbers are considered.

  • Only those events from the cases that have the Seiyakukyo products specified as:

    Related - At least one of the As Reported and As Determined Causality in the case is specified as Reportable for this Product Event combination.

    Unlisted - Specified as Unlisted in the case against at least one Japanese Marketed or Investigational license (License Drug Authorization Country as Japan) having same clinical compound number as configured in Seiyakukyo report. The Listedness specified as Unknown is not considered.

    Serious - The event is specified as Serious.

  • All the events in the Seiyakukyo report for Foreign Ichihen Study Cases are sorted in the following order:

    • Case ID Number (ascending)

    • Japan Information Receipt Date (significant follow-up or Initial Receipt Date) (Old to New)

    • Events as ordered in the case

• If the checkbox to include foreign AE marked as Not include for the report in Japan is checked on the Individual Report Common Line List Configuration tab, those events are also included. Else, such events are ignored from the cases.

4.2.9.4 Report Output Field Mappings

4.2.9.5 CSV Output Format

The Seiyakukyo report also supports printing in the CSV format.

• The Seiyakukyo configuration data is not printed in the CSV format. Only the main Seiyakukyo report output is printed in CSV format.

• The Report Title is put as the first value in the first row.

• All the event rows from the report output including the Header row are put in separate rows.

• The MedDRA J version and Section Footer Text are put as separate rows at the end, in the same way as the report output.

• Each cell value for a row is put as individual item within that row in the CSV format.

• All the comma characters and new line characters within a cell value are supported and maintained in the CSV format. It must not break that cell value into multiple items in CSV. This is achieved by using double quote characters for the cell values to escape such characters.

• All the double quote characters within a cell value are replaced by 2 double-quote characters in the CSV format.

• All valid Japanese characters as specified for the PMDA E2B file (Main ESM J SRS > 19.6.1 point # 15 (c)) are supported by this CSV format.

• Different sections related to different case types and Clinical Compound Numbers are separated by a single blank line.

4.2.9.6 Periodic Report Process Flow

The Seiyakukyo Periodic report is handled in the same manner as other Japanese Periodic reports - PSR/ReSD and CSPSR. All the actions that are applicable to the existing Japanese reports are supported for Seiyakukyo Periodic reports as well.

• All the configured Seiyakukyo reports are listed on the Periodic Report Configuration page.

• All the actions supported on the Periodic Report Configuration page for CSPSR are supported for Seiyakukyo reports as well.

  • New Report

  • Copy

  • Modify

  • Delete

  • Print

• The Print dialog box for Seiyakukyo lists 2 output formats in the drop-down adjacent to the Run Now option - Word and CSV. The Word output format is selected by default.

  • Choosing the Word format for the Run Now action and clicking the OK button displays the output of the Seiyakukyo reports in Word format in the similar manner as CSPSR.

  • Choosing CSV format for Run Now action and clicking the OK button displays the Seiyakukyo reports in CSV format.

  • Irrespective of the format - Word or CSV, if the report is executed as Final or Draft, it is available in the same format through the standard - FINAL and DRAFT links in the row for that report on the Periodic Report Library screen. In case, you have executed the report with Internal and other options, it is available in the same format using the DRAFT link on the Periodic Repot Library screen.

  • No Watermark is put on the CSV format output. It is applicable only for the Word format output in the similar manner as CSPSR.

  • If a Submitted report is attempted to be printed in the CSV format, the application displays the following error message with the OK button:
    The report is already submitted. You cannot print this report again in CSV format.
    However, for Word format, it prints the Configuration page only without any error message.

• All the Seiyakukyo reports are also listed on the Reports > Compliance > Periodic Reports screen.

• All the actions supported on Reports > Compliance > Periodic Reports screen for CSPSR are supported for Seiyakukyo reports as well.

• The View and Edit Seiyakukyo dialog box (View Report right-click menu option) from Reports > Compliance > Periodic Reports screen, supports all the actions (in same manner as View and edit J-DSUR dialog box for CSPSR) for Seiyakukyo Word as well as CSV formats.

  • View

  • Check-in

  • Check-out

  • Publish

• The View or Check-out option displays the Seiyakukyo report in the same format (Word or CSV) that is chosen/checked-in by you.

• You are allowed to check-out the report in one format (CSV) and check-in the file in other format (WORD).

• If you click the Publish button and the last checked-in file is in the CSV format, it displays the following warning message with Yes and No buttons:
  As this report exists in CSV format, it will not be converted into PDF format while publishing it. It will be published as it is in CSV format itself. Do you want to proceed?