6 Import ICSR Reports

6.1.1 Search for Duplicate Cases

The Duplicate Search dialog for E2B report allows you to search for possible duplicate cases in the Argus Safety system. You can select different combinations of search criteria. When more than one criterion is selected, only cases that satisfy all criteria are listed. By default, only the fields that are present in the E2B Report are checked for the Duplicate Search.

Use the following procedure to perform a duplicate search.

1. Select Reports -> ICSR Pending Report.

2. When the system opens the Incoming E2B Reports dialog, right-click a case to perform a duplicate search.

3. The system displays the search results at the bottom of the dialog box.

6.1.2 Use the View Differences Report

The View Differences Report enables you to view differences between the following:

• The current XML being imported (a message not yet imported into the database)

• The current case data in the database

• The last imported case.

Click View Differences from the Duplicate Search screen to view the View Differences report. View Differences is available only for follow-up and nullification reports only.

The following table lists and describes the fields in the View Differences report:

6.1.3 View the E2B Report

Use the following procedure to view the E2B Report:

1. Select Reports -> Duplicate Search and right-click to the Duplicate Search dialog box.

2. Click View E2B to view the E2B report in the ICSR Viewer.

6.1.4 Accept Single/Multiple E2B Reports

Use the following procedure to accept single and multiple E2B reports:

1. Select Reports -> E2B Pending to open the Incoming ICSR Report dialog box.

2. When the system opens the Incoming ICSR Report dialog box:

   Select Accept ICSR to accept a single report

   OR

   Select the check boxes for each report and click Accept ICSRs to accept multiple reports.

3. When the system opens the Acceptance of Initial Report Confirmation dialog box, enter the password and any relevant notes.

4. Click OK to accept the case.

   Note:

   Accept ICSRs can be performed only when the system numbering is set to Automatic.

5. If the system is configured to automatically number cases, the system opens the case accepted dialog appears with the generated case number.

6. Click OK to close this dialog.

   Note:

   If the system is configured to manually number cases, you will be prompted to enter a case number for the case that is being accepted.

For PMDA R3:

The case acceptance procedure supports the batch import of the R3 message (unlike PMDA E2B R2).

6.1.5 E2B Initial/Follow-up Intake

During case acceptance, you can access selective acceptance fields in the report.

• The Selective Acceptance feature is enabled only for single initial ICSRs and is a right-click option.

• If you select multiple ICSRs, the system disables this button.

• If you select a single follow-up or nullification ICSR, the system disables this button.

• When the system displays the E2B Difference Report dialog, you can select the elements required to create or update a case without the system displaying the Case Number and Follow-up Number in the difference report dialog for initial reports.

• The following changes have been made to the Initial Intake and the Follow-up Difference Report dialogs:

  • The system displays the decoded view to enable you to select the elements (e.g., US [United States]).

  • The system prints the check box options for the Initial Intake and Follow-up Difference Report dialogs.

  • The label is updated to Select when selecting elements for the Initial Intake and the Follow-up Difference report dialog.

• You must select the following fields before the system will permit you to accept the Initial case. By default, all the fields are selected.

  • Country of Incidence (default and grayed out)

  • Report Type (default and grayed out)

  • Initial Receipt Date (default and grayed out)

  • Any one Product

  • Any one Event Term

• If you fail to select these fields, the system displays the following message:

  E2B cannot be imported as it does not meet minimum Argus requirements.

• The system permits you to print the Initial ICSR report.

• When you click Accept Initial, the system displays the Accept E2B Case dialog. When you complete the data elements and click OK, the system displays the Error/Warning message dialog for any elements you have selected.

• Once you accepts the case as an initial or follow-up case, the system attaches the Source XML (ICSR) and the Initial Selection PDF to the case in the Additional Info tab.

• Initial/Follow-up Source XML

  • Attachment Classification. As specified in the Reporting Destination for the XML source classification.

  • Date. The system date when the case you accepted XML for the case.

  • Description. The acceptance notes you entered for XML.

  • When you click the Source ICSR, you can see the ICSR when opening the ICSR View (E2B Viewer).

• Initial Selection PDF

  • Attachment Classification: As specified in the Reporting Destination for the Selection Source Classification.

  • Date: The system date when you accepted XML for the case.

  • Description: The date you entered acceptance notes for XML.

• Follow-up Source XML

  • When you click the Source ICSR PDF or the E2B Difference Report, you can view the Initial Selection PDF or the E2B Difference Report in a different IE window.

• Once you accept a case as an initial or a follow-up ICSR, the system prefixes the Business Level Acknowledgement Notes with the case number in the following format:

  Imported Case #: XXXXXX

  where:

  XXXXXX is the case number

• The system attaches the current notes sent in the Business Level Acknowledgement.

• If the system receives the ICSR via the physical gateway (configured at the reporting destination level), the system sends a low level ACK to indicate the file was received by the Argus Interchange Service.

• For Auto Accepted ICSRs, the system does not attach the source PDF in the case because the source XML is attached.

• The system places this file in the Physical Out folders as configured for the reporting destination in the E2B Mapping Configuration.

• For EDI received files, the system continues to let the EDI Gateway send the low level ACK as it does currently.

• The Interchange Services does not process the low level ACK received in the Physical In destination folder, but enters any errors in the log file since the file will always be rejected by the Interchange Service.

6.1.6 E2B Follow-up Acceptance for Closed/Locked Cases

• If you try to accept follow-up information for a closed or locked case, the system prompts you to unarchive or unlock the case for processing after entering the password and acceptance notes.

• If the system archives a case while you are accepting the report, the system displays the Case Re-open dialog to enable you to open the case.

• If the system locks a case while you are accepting a report, the system displays the Case Unlock dialog to enable you to unlock the case.

• After the you reopen the case, the system accepts all updates as defined in the follow-up information you selected.

• If the you do not have permission to reopen an archived or locked case, the system displays the following message:

• You do not have permission to Re-open an Archived/Closed case or Locked Case.

• If you select multiple open, locked, or archived cases or if you do not have permission to open the case, the system skips the cases.

• The system does not create follow-up actions for cases that it accepts automatically.

6.1.7 Source XML Received for the Case

Once Argus accepts a case as an initial or follow-up case, the system attaches the source XML (ICSR) and the Initial Selection PDF to the case in the Additional Info tab as follows:

• Initial/Follow-up Source XML

  • Attachment Classification &endash; As specified in the Reporting Destination for XML Source Classification.

  • Date &endash; The system date when the user accepted the case for XML.

  • Description &endash; The acceptance notes entered by the user for XML.

  • When the user clicks the Source ICSR, the system permits the user to view the ICSR by opening the ICSR Viewer (E2B Viewer).

• Initial Selection PDF

  • Attachment Classification. As specified in the Reporting Destination for Selection Source Classification.

  • Date. The system date when you accepted the case for XML.

  • Description. The acceptance notes you entered for XML.

• Follow-up Source XML

  • When you click the Source ICSR PDF or the E2B Difference Report, the system enables you to view the Initial Selection PDF or the E2B Difference Report in a different IE window.

• When you accept the case as an initial or follow-up ICSR, the system inserts the case number before Business Level Acknowledgement Notes in the following format: Imported Case #: xxxx

• If the system receives the ICSR via the physical gateway, it sends a low level ACK to indicate that the file was reviewed by Argus Interchange Services.

  • The system places the file in the Physical Out folders as defined in the reporting destination configured in the E2B Mapping.

  • When the system receives files from EDI, the system continues to let the EDI Gateway send the low level ACK.

  • The Interchange Services does not process the Low Level ACK in the Physical In destination folder but enters any errors in the log file because the file will always be rejected by the Interchange Service.

6.1.8 Import E2B (R3) Messages

• The import process for PMDA E2B R3 imports a single xml file similar to that of a EMA R3 message (unlike PMDA E2B R2 which consists of two files I & J).

• ICSR Import logic for PMDA E2B R3 enables you to import an incoming ICSR file using PMDA E2B R3 profile that consist of only ICH elements i.e. if there are only the ICH elements present in the incoming message, the files would still be imported for ICH elements.

• In the incoming ICSR message for both PMDA E2B R2 and R3, if there is no J2.1a (for R3) and J.4a(for R2) value in the incoming ICSR message then it is considered as Marketed ADR report, and either domestic or foreign is decided based on the COI identified on the data in the incoming ICSR (Primary reporter country or the Reaction occur country).

• Similar to that of PMDA E2B R3 export (same as ICH and EMA) the incoming PMDA E2B R3 messages is expected to be in UTF-8 format rather than the Shift-jis. In case of PMDA E2B R2 (in Argus the encoding is governed based on the Reporting Destination configuration).

• The following are the PMDA E2B R3 specific rules applied to validation logic during import of PMDA E2B R3 file:

  • During validations, the special internal logic of considering the Nullification report as Completion Report (J2.7.1-MHLWADMICSRCOMPLETECLASSR3="completed") is considered applicable for PMDA E2B R3. Additionally, the same logic is extended for the Downgrade report for the PMDA E2B R3 message.

  • The following is the Minimum case creation validation logic for Reaction for PMDA E2B R3 Research & measure (AE, AF, DE,DF, BC, BD, AG, or DG) category of report:

    If the incoming file does not comprise a Reaction than a Dummy relation is used during executing the minimum case validation.

    (For details on the profile switch, refer to Oracle Argus Japan Administrator's Guide).

    (For details on minimum case validation, refer to Oracle Argus Interchange User Guide (English), section ICSR Import Framework.)

  • The following is the COI Identification logic for Minimum case validation:

    If Reporting Category is AE, AF, DE, DF, BC, BD, AG, or DG, then fetch the value based on the availability in the following order:

    a. Fetch COI from the Primary Reporter C.2.r.5= 1.

    b. Fetch COI from E.i.9.

    c. Fetch the country from the First reporter which has valid C.2.r.3 value.

• In the incoming PMDA E2B R3 message file the following date elements might contain the time zone component. In case these date elements contain the time zone offset, then adhere to that time zone offset in the element value while converting it in the GMT.

  • J2.2.1 - Date of Reporting

  • N.1.5 - Date of Batch Transmission

  • N.2.r.4 - Date of Message Creation

  • C.1.2 - Date of Creation

  • C.1.4 - Date Report Was First Received from Source

  • C.1.5 - Date of Most Recent Information for This Report

  Argus supports time component for N.1.5, N.2.r.4, and C.1.2 only.

  In case C.1.4, C.1.5, and J2.2.1 values are in CCYYMMDD precision i.e. without the time component then consider the incoming value to be in GMT and store it without any transformation.

  Sample date formats:

  • 23-Jan-2017 08:30 +3.5

    EMA & PMDA: +3.5 for converting it to GMT: > If Argus support's time, then save the converted date.> If Argus does not support's time, then strip the time from converted date, and save.

  • 23-Jan-2017 08:30

    EMA & PMDA:

    > If Argus support's time, then save the incoming date as-is.> If Argus does not support's time, then strip the time from as-is date, and save.

  • 23-Jan-2017

    EMA & PMDA: Save the date as-is.

• PMDA E2B R3 regulation have introduced as a new concept of Urgent Report (J2.3 (MHLWFLAGFORURGENTREPORT) = 1). The Urgent Report is treated as regular initial or a follow-up report as applicable.

• The application logic for attachment import supports the compression algorithm as per the profile switch "Compression algorithm for file attachments in PMDA E2B R3".

• Similar to that of EMA E2B R3, if the Reporting destination is configured to transmit the Attachments then the PMDA E2B R3 import logic imports all the valid attachments that are allowed to be added into the case form as configured in the profile switch "Case Processing > Valid Attachment File Types".

6.1.9 ICSR Pending Screen for (R3) Report

• Pending screen filter displays an additional value "Urgent Report" in the existing Reports> ICSR Pending > Report type drop-down list.

• The search grid indicates the Urgent reports by appending "(Urgent)" in the "Initial / F-U / Nullification/ Amendment" column after the actual report type. For example, if the Initial report is an urgent report then the column value is displayed as "Initial (Urgent)".

• In the Pending screen context menu, the E2B Viewer displays the same options as in PMDA E2B R3 Report export i.e. it supports the viewing of the PMDA Paper report. Besides, the default view settings for E2B Viewer remains same as for PMDA E2B R3 export.

6.1.10 PMDA E2B R3 ACK

• PMDA E2B R3 Acknowledgment Template profile "ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - PMDA" is available in the application.

• Similar to EMA R3, PMDA E2B R3 supports Batch Acknowledgement transmission. The acknowledgements pertaining to ICSR received in the batch are sent only after processing all the ICSRs present in the XML file.

• The application supports the generation of the low level ACK for the PMDA E2B R3 ICSR message imported in Argus using physical media option at Agency level.

• The application generates PMDA E2B R3 ACK as an XML file with the following file name format (unlike PMDA E2B R2 where it was a SGML):

  A-<Company's Abbreviation>-<Date of Reporting>-<unique number>.xml

  Attribute	Description
  Company's Abbreviation	Code List > Reporting Destination > EDI Tab> Company Identifier
  Date of Reporting	System date in Japan Time zone (using profile switch JPN_OFFSET) "YYYYMMDDHHMIss" format.
  Unique number	This unique number must be alpha-numeric value constructed by concatenating the Case Number and last 2 characters of SAFETYREPORTID tag value (i.e. AA, AB, and AC etc.).For example if the case number is "15JP000236" and Safety Report ID is "JP-SENDER-JAPAN-15JP000236AA" then the Unique number will be "15JP000236AA".In case of a batch ACK, use the case number form the first case of the batch.

  
  

6.2.1 Total Number of Rows Fields

The following table lists and describes the fields in the Total Number of Rows section on the Processed ICSR screen.