Buttons/Icons
Name
Description
To be processed by ESM icon
Click to view the cases distributed but not yet processed by ESM Server.
Ready to be Exported
Click to view the cases that are ready for export in ESM.
Case awaiting Ack.
Click to view the exported cases that are awaiting acknowledgment.
Error Section
Click to view the error cases that are not exported due some missing information or parsing error.
Ack with parsing error
Click to view the acknowledgments received with parsing error for the exported ICSRs or the acknowledgments generated with parsing error for the imported ICSRs.
Successful Ack
Click to view the acknowledgments received successfully for the exported ICSRs or acknowledgments generated successfully for the imported ICSRs.
Incomplete Ack
Click to view the incomplete acknowledgments received for the exported ICSRs or incomplete acknowledgments generated for the imported ICSRs.
IA not updated
Click to view the cases for which informed authority record is not yet updated.
Ready to be Imported
Click to view the cases that are ready for importing into ARISg database.
Cases Re-processed (Export cases)
View the number of export cases that are getting reprocessed.
Cases Re-processed (Import cases)
View the number of import cases that are getting reprocessed.
Easy View
Click to view the case in a user-friendly readable format and E2B Printable format.
/
MedWatch Report view
Click to view the case as a PDF document in MedWatch format.
/
CIOMS Report view
Click to view the case as a PDF document in CIOMS-I Format.
/
E2B form view
Click to view the case in the E2B ARISg easy view format.
/
E2B XML View
Click to view the case in the E2B XML view format.
This icon is displayed for message number in Import Section and AER numbers in Export Section.
R2 View
Click to view R3 xml data in R2 xml format.
E2B XML View
Click to view the case in the E2B XML view format.
This icon is displayed for Safety Report IDs in Import Section.
Acknowledgement
Click to view the acknowledgment in E2B View.
View Log
Click to view the Import Log Details page.
Transaction Details
Click to view the Transaction History page.
Back
Click to return to the previous page.
Receiver’s details
Click to view the contact information of the Receiver for a case.
Follow up
Indicates that the case is a follow up case.
Compare ICSR
Click to compare the E2B case in the Import Section with the existing case (case in ESM import section, archive section and the imported cases in ARISg).
Append to Existing
Click to mark a follow-up case as appending existing of a latest version of the existing case in ARISg.
Import Safety Report
Click to import the selected ICSR file into ARISg system. For more information on importing a ICSR file, refer the Importing a Case section.
Reject Safety Report
Click to reject the selected ICSR file in the ARISg system. For more information on rejecting a ICSR file, refer the Rejecting a Case section.
Don Not Import
Click to mark an incoming E2B file as Do Not Import. If you mark an incoming E2B files as Do Not Import, the case is not imported to ARISg database and the positive acknowledgment is generated and sent to the sender so that the sender do not send the same file again. For more information on marking the a received ICSR file as Do Not Import, refer the Marking a Case as Do Not Import section.
Don Not Import All
Click to mark all the selected message number and the associated safety reports as Do Not Import.
Import Message
Click to import all the selected Message Number and their corresponding ICSR files into ARISg System. For more information on importing selected message numbers, refer the Importing a Case section.
Reject Message
Click to reject all the selected Message Number and their corresponding ICSR files in the ARISg System. For more information, refer the Rejecting a Case section.
Can be Imported/Rejected/DNI
Indicates that case can be Imported, Rejected or mark as Do Not Import.
Rejected
Indicates that case is rejected.
Imported
Indicates that case is Imported.
Not Imported
Indicates that the case is not imported as the case is marked as Do Not Import.
Unapproved Version Exist in the Database
Indicates that the unapproved version of the case exist in ESM server queue.
This icon is displayed against the cases that are imported from the Import Section but unapproved version of the case exists in the ESM server queue.
Upload
Click to upload an ICSR file from the local drive.
Batch Import
Click to import the selected messages and their corresponding ICSR files.
Batch Reject
Click to reject the selected messages and their corresponding ICSR files.
HPID Search
Click to search the HPID records.
Successful
Indicates that the ICSR file is imported or exported successfully in ESM
or
Indicates that the case acknowledgment successfully generated for imported case or successfully received for the exported case.
Note: This icon is available in Archived Case - Export/ Import Section and Acknowledgements - Exported/ Received ICSRs page.
Parsing Error
Indicates that the case acknowledgment is generated or received with an SGML parsing error or individual ICSR report field error.
Incomplete
Indicates that the incomplete case acknowledgment is generated or received as the case could not pass the DTD validation and parsing by the ESM application.
Load with Error
Indicates that the case acknowledgment is generated or received and loaded into target database with error.
Suppressed Acknowledgment
Indicates that the acknowledgment generated for an imported case is marked as suppressed as it is not exported to the sender.
Warning
Indicates that the case acknowledgment is generated or received with a warning.
Re-Classification
Click to reclassify a case.
For more information, refer the Reclassifying a Case section.
Re-Classified
Indicates that the case is reclassified.
Bulk Export
Click to export the multiple selected cases from the Export Section.
Ichicsr
Indicates that the message type of the case is Ichicsr.
backlog
Indicates that the message type of the case is backlog.
backlogct
Indicates that the message type of the case is backlogct.
psur
Indicates that the message type of the case is psur.
ctasr
Indicates that the message type of the case is ctasr.
cticsr
ICSRs expedited report from interventional clinical trials.
dsuricsr
ICSRs non-expedited report during interventional clinical trials.
camricsr
ICSRs expedited reported as per guidance for Canada Access to Medicines Regime and submitted to Canada Vigilance Database (CVD).
sapicsr
ICSRs expedited reported as per guidance for the Special Access Programme submitted to Canada Vigilance Database (CVD).
Others
Indicates that the case as a custom mapped message type other than the above listed Message Types.
master
Message type of cases processed by merging two-or-more cases into one Master Case created from identified duplicates
recoded
ICSRs that are updated due to recoding activities.
master- recoded
Master cases that are updated due to recoding activities.
Help
Click to open the ESM help window for the current page. In the help window, you can view the description of the fields, buttons and icons for the current page.
For example, if you click this button on the Import Section page then the help window Import Section page is displayed.
Case Transmission (Case Export)
Transmits cases in a batch. Select the check
box corresponding to the cases that you want to export and click
.
Note: Batch export of the backlog/psur/ctsar message type cases must not exceed 100.
Printable Version
Click to generate the printable view for a listing page with all the cases listed without pagination.
This button is available on the following ESM listing pages:
Import Section
Export Section
Case Awaiting Acknowledgment
Acknowledgments
Archived Cases
Deleted Cases
Error Section
Click to print the current page in plain text format. For better appearance, change the format type to landscape in the Printer Properties dialog box.
Archive
Click to archive the selected acknowledgements
and the corresponding ICSRs. Select the check box corresponding
to the Acknowledgements
that you want to archive and click .
Delete
Click to delete the selected records.
Search
Click to search the record based on the specified criteria.
Advanced
Click to open the advanced search page.
Clear Locks
Click to clear locks for the selected cases.
Delete
Click to delete the corresponding record.
Download
Click to downloads the ICSR file into your local drive in a SGML or XML format.
Truncation
Indicates that the case contains truncated data.
Note: This feature is available only for acknowledgements of imported ICSRs and archived imported ICSRs.
Local Data Entry
Indicates that the case has Local Data Entry privilege.
Click to edit the local information related to the case, before submitting the case to the affiliates.
Successfully processed
Indicates that the attached document is processed successfully for the case.
Partially processed
Indicates that the attached document is processed partially for the case.
Error
Indicates that the attached document for the case is processed with error.
Warning message
Click to view the error message for a case on the Error Section page.
Delete Reason
Click to view the reason for deleting a case. This icon is available only on the Deleted Cases page.
Refresh
Click to refresh the current page.
Report - A
Indicates that the case is a local infection case report (PMS).
Report - B
Indicates that the case is a local adverse event case report (PMS).
Report - c
Indicates that the case is a international infection case report (PMS).
Report - D
Indicates that the case is a international adverse event case report (PMS).
Report - E
Indicates that the case is a study report on infectious disease (PMS).
Report - F
Indicates that the case is a study report on adverse event (PMS).
Report - G
Indicates that the case is a safety report of discontinuation, callback and disposal of drugs (PMS).
Report - H
Indicates that the case is a local infection case report (IND).
Report - I
Indicates that the case is a local adverse event case report (IND).
Report - J
Indicates that the case is a international infection case report (IND).
Report - K
Indicates that the case is a international adverse event case report (IND).
Report - L
Indicates that the case is a study report on infection disease (IND).
Report - M
Indicates that the case is a study report on adverse event (IND).
Report - N
Indicates that the case is a safety report of discontinuation, callback, and disposal of drugs (IND).
Report - O
Restricted Study Report: This report is the study report on adverse event caused by post marketed drug which is an import prohibited or restricted drug in Japan and has restricted purpose of use.
Report - P
Cosmetic Study Report: This report is the study report on adverse event caused by cosmetic products.
Report - AA
Indicates that the case is a local infection case report (PMS) relevant to MHLW reports for E2B (R3) submission.
Report- AB
Indicates that the case is a local adverse event case report (PMS) relevant to MHLW reports for E2B (R3) submission.
Report – AC
Indicates that the case is an international infection case report (PMS) relevant to MHLW reports for E2B (R3) submission.
Report – AD
Indicates that the case is an overseas adverse event case report (PMS) relevant to MHLW reports for E2B (R3) submission.
Report – AE
Indicates that the case is a research report for infections (PMS) relevant to MHLW reports for E2B (R3) submission.
Report – AF
Indicates that the case is a research report for adverse reaction (PMS) relevant to MHLW reports for E2B (R3) submission.
Report – AG
Indicates that the case is a measure report of overseas manufacture discontinuation, Recall and discard of drugs (PMS) relevant to MHLW reports for E2B (R3) submission.
Report – DA
Indicates that the case is a local infection case report (IND) relevant to MHLW reports for E2B (R3) submission.
Report – DB
Indicates that the case is a local adverse reaction case report (IND) relevant to MHLW reports for E2B (R3) submission.
Report – DC
Indicates that the case is an overseas infection case report (IND) relevant to MHLW reports for E2B (R3) submission.
Report – DD
Indicates that the case is an overseas adverse reaction case report (IND) relevant to MHLW reports for E2B (R3) submission.
Report – DE
Indicates that the case is a research report for infection (IND) relevant to MHLW reports for E2B (R3) submission.
Report - DF
Indicates that the case is a research report for adverse reaction (IND) relevant to MHLW reports for E2B (R3) submission.
Report - DG
Indicates that the case is a measures report of overseas manufacture discontinuation, recall and discard of drugs (IND) relevant to MHLW reports for E2B (R3) submission.
Report - BC
Quasi-drug Research Report: This report is the research report on adverse event caused by post marketed drug which is an import prohibited or restricted drug in Japan and has restricted purpose of use relevant to MHLW reports for E2B (R3) submission.
Report - BD
Cosmetic Research Report: This report is the Research report on adverse event caused by cosmetic products relevant to MHLW reports for E2B (R3) submission
Standard DTD
Indicates that the xml file is in standard doctype format.
Custom DTD
Indicates that the xml file is in custom doctype format.
E2B R3 DTD
Indicates that the xml file is in E2B R3 format.
HL7 R1 DTD
Indicates that the xml file is in HL7 R1 format.
MIR PDF Report
The MIR report in PDF format. The MIR PDF report is available in Export section, Cases Await Acknowledgemnt and Archive section.