You can view the acknowledgements for the successfully exported cases.
Note: While importing an acknowledgment file for message, if the message number is blank in the acknowledgment file then the acknowledgement is moved to Archived section and appropriate log is added in the import log file.
To view the acknowledgments:
In the ARISg menu, click ESM > E2B Export section > Acknowledgements to open the Acknowledgements received for Exported ICSRs page > E2B (R2) tab.
Click the E2B (R2), E2B (R3), eMDR (R2) or eVAER(R3) tab to view the acknowledgements for the exported cases on the E2B (R2), E2B (R3), eMDR (R2) or eVAER(R3) tab respectively.
Acknowledgement Received for Exported ICSRs Page
Refer the following field description table for more information on the fields, icons and the tasks that you can perform on this page.
Acknowledgement Received for Exported ICSRs Field Description Table
Field |
Description |
Dup. Ack. |
The duplicate acknowledgment
icon ( |
S |
The status of the cases. Following icons represents the status of the cases:
|
AER Number (Ver. Loc Ver) |
The adverse event reaction number of the case. Ver denotes the version of the case and Loc Ver denotes the local version of the case. Click the AER number link to view the corresponding ICSR or eMDR file in XML format. Note: Application displays [+] Icon beside the AER number if the case is exported as part of batch processing. The batch cases are merged as a single case. The AER Number is prefixed with respective message type icon. For more information on message type icons, refer to Buttons and Icons used in ESM Web Interface. |
Receiver |
The name of the receiver organization who has received the acknowledgment for the current exported case. |
Sent |
The date on which the acknowledgement is sent. |
ICSR MDN |
In this field, you can view the date on which Message Disposition Notification (MDN) message is generated for the current ICSR or eMDR file. The ICSR MDN is the official receipt date on which the safety message is successfully transmitted to the authorities through the ESTRI Gateway. Click MDN date link to view the MDN message on the MDN Message window. For more information, refer the Viewing MDN Messages section. |
Ack MDN |
The ACK-MDN is the official receipt date on which the acknowledgement message for the MDN is transmitted through the ESTRI Gateway. |
Ack. Date |
The date on which the acknowledgment is received for the exported case. If the case has a warning, then a warning
icon |
Cases |
The total number of cases associated with current AER number. |
R |
The type of the MHLW report type to which current case is associated with. Click the corresponding MHLW report type icon to generate the MHLW report in PDF or Word format. This field is not displayed for acknowledgements received for the exported eMDRs listed on the eMDR (R2) and eVAER(R3) tabs. Refer the Working with MHLW E2B Reports section for more information. |
View |
Click Click For more information, refer to Viewing Acknowledgements Details section. |
|
Click to download the acknowledgement in XML format. |
A |
The status of the attached document for a case. The following icons represents the status of the attached document:
Click the attachment icon to open the Attachment Details window. The attachment detail window displays the Safety Report Identification, MDN, Acknowledgement MDN, Attachment icon, and Acknowledgement Icon for the attached document. Click on the respective link or icon to view the Attach MDN, Ack MDN, attached document and Ack details. For more information on attachment, refer to Viewing Attachment Details section. |
User Distributed |
Displays the name of the user who distributed the case from ARISg to ESM export section. |
To view the duplicate acknowledgements for an exported case:
On the open the Acknowledgements received for Exported ICSRs page,
click 
icon
for the case for which you want to view the duplicate acknowledgments.
The Duplicate Acknowledgments pop-up window appears.
In the Duplicate Acknowledgments pop-up window, you can view the number of successful and failed duplicate acknowledgements (including archived duplicate acknowledgments) received for the selected case.
Click
to
view the details for a duplicate acknowledgment.
Click Close to close the Duplicate Acknowledgments pop-up window
On this page, you also can manually archive the exported cases for which transactions are completed.
To archive a case manually:
On the Acknowledgements received for Exported ICSRs page, click the E2B (R2), E2B (R3), eMDR (R2), eVAER (R3) or MIR tab, and select the check box for the exported cases that you want to archive.
Click 
.
Note: If the ESM Archive based on Date Informed Field check box (ARISg Administration >Security menu > Users > User Maintenance tab) is selected for the user or company unit (who has distributed the case) then application does not allow you to archive the case until Date Informed field in Informed Authority (IA) record is updated for the case. However, the application will not check if IA is updated or not for negative Acknowledgement cases during archival operation.
If the Re-authenticate for Archive parameter is selected in the ESM Admin > Setup > General tab for archive operations, application prompts the user for re-authentication.
The User Authentication dialog appears.
User Authentication dialog
Enter the log on username and password, and click OK to archive the selected cases.
A message "Successfully 'archived' Selected ICSR (s)" is displayed with Details link.
Click the Details link to view the list of AER number of the cases that are currently archived manually.
The cases that are archived manually are moved to Archive Section. For more information, refer to Viewing Archived Cases.
Note: The application performs Audit trail whenever cases are manually archived based on the security privileges of the user.
is displayed beside the acknowledgment
date.
to view the acknowledgement details in the XML view.
