Viewing Archived Cases

In agXchange ESM, you can set the automation rule to archive the cases whenever:

An acknowledgment is sent.
An acknowledgment is received.
A case is exported.

If the archive request in queue fails to process the case then the ESM server picks the next valid request from the queue to process.

The failed archive request is processed in the subsequent pooling cycles in ESM Server based on the maximum number of attempts set on the ESM Configuration page (ARISg Administration > ESM menu > Setup > ESM Configuration).

Note: For failed requests, the maximum number of attempts can be set between 3 and 99.

The ESM server tracks the failure attempts of archive request based on the value in ATTEMPT_COUNT column in the E2B_MESSAGE_QUEUE and E2B_UNSTRUCTURED_DATA tables. If the case in the queue cannot be processed then attempt count will be incremented until maximum attempt defined in the ESM property file is reached.

If a request is failed to process in the next pooling cycle then that request is re-ordered with date modified and attempt counts by the ESM server so that other cases are picked for processing up in the order.

While processing the failed requests in the subsequent pooling cycles, the ESM server will re-arrange the requests such that the request with least attempt count is picked first. If the attempt count is same for multiple requests then the requests are processed based on the date modified.

When attempt count reached maximum number of attempts set on the ESM Configuration page, an alert is sent to the relevant user to notify that the archive request is not processed.

For example, if the maximum number of attempts is set as 50 then the ESM server will process the failed request until it get processed before next 50 pooling cycles and while processing the request for the 50^th time, if request fails then an alert is sent to the relevant user to notify that the archive request is not processed.

If archive request reached maximum attempt count then a notification e-mail is sent to the user who performed import operation, and to alert e-mail ID specified on the Alerts and Notifications page (ARISg administration > ESM menu > Alert configuration).

In case of automation, notification e-mail is sent to alert e-mail ID specified on the Alerts and Notifications page.

You can set the automation rule to archive the cases in the ARISg Admin > ESM menu > Setup > General tab.

You also can manually archive the cases (both export and import cases) for which transactions are complete.

For more information on archiving the cases manually, refer the following sections:

In the E2B archived cases section, you can view the cases (both export and import cases) that are archived automatically and manually. You can search for the archived cases based on the various criteria.

To view archived cases:

In the ARISg menu, click ESM > E2B Import or E2B Export section > Archived Cases Section.

The Archive Section: Advanced Search appears.

Click the E2B (R2), E2B (R3), eMDR (R2), eVAER (R3) or MIR tab to search for the archived cases in the corresponding format.

Archived Cases page for exported cases

Refer the following field description table to enter or select various search options to view the archived cases:

Archive Section - Advanced Search Field Description Table

Field	Description
Archive Section	Select the option to view the archived cases for export or import transactions. The available options are: Archive Section - Export: Select this option to view the archived cases for export transaction. Archive Section - Import: Select this option to view the archived cases for import transaction.
Message type	Select the message type if you want to search the archived cases based on the selected message type. The available message types are: All ichicsr backlog backlogct psur ctasr ctics dsuricsr camricsr sapicsr master recoded master-recoded Note: Select 'All' to retrieve all the message type cases. This field is not available when you perform search from the eMDR (R2) tab.
Message Number	Enter the message number associated to the case to search the archived cases based on the specified message number.
Receiver or Sender	If the Archive Section - Export option is selected in the Archive Section drop-down, select the name of the receiver organization who has received the exported cases. or If the Archive Section - Import option is selected in the Archive Section drop-down, select the name of the sender organization who has sent the imported cases. Note: For Japanese transmission, enter the Receiver Interchange Id in this filed.
Sent Between Dates or Received between dates	If the Archive Section - Export option is selected in the Archive Section drop-down, select the date range in the From Date field and To Date field to search for the archived cases that were sent to the authority or partner between the specified date range. or If the Archive Section - Import option is selected in the Archive Section drop-down, select the date range in the From Date field and To Date field to search for the archived cases that are received between the specified date range.
Archived Between Dates	Select the date range in the From Date field and To Date field to search for the cases that are archived between the specified date range.
AER Details Under this section, you can search the ICSR cases based on either one or a combination of the following search criteria.
AER No.	Enter the unique AER number of the archived case that you want to view.
Medicinal Product	Enter the name of the medicinal product that caused the adverse event. Application retrieves the archived cases that are associated with the specified product name.
Primary Source Country	Select the primary source country where the adverse event is first registered. Application retrieves the archived cases that are first registered in the specified country.
Primary Source Reaction	Enter the primary source reaction that caused the adverse event. Application retrieves the archived cases that are associated with the specified reaction.
Seriousness	Select the severity of the adverse event. The available options are: Serious Not serious Both Bases on the selected seriousness, application retrieves the ICSR cases.
MHLW Report Type or Safety Report ID	If the Archive Section - Export option is selected in the Archive Section drop-down, select the MHLW report type from the following options: Local Infection case report (PMS) Local Adverse Event case report (PMS) International Infection case report (PMS) International Adverse Event case report (PMS) Research Report For Infection (PMS) Research Report For Adverse Event (PMS) Measures Report for Discontinuation, Callback, and Disposal of Drugs (PMS) Local Infection case report (IND) Local Adverse Event case report (IND) International Infection case report (IND) International Adverse Event case report (IND) Research Report for Infection (IND) Research Report for Adverse Event (IND) Measures Report for Discontinuation, Callback, and Disposal of Drugs (IND) Quasi-drug Research Report Cosmetics Research Report Request for Nullification reports Application retrieves the archived cases that are associated with the selected MHLW report type. or If the Archive Section - Import option is selected in the Archive Section drop-down, enter the unique identification number of the archived safety report to search the archived case. This field is not available when you perform search from the eMDR (R2) tab.

Click Search.

The Archived Cases: Export Section page > E2B (R2), E2B (R3), eMDR (R2), eVAER (R3) or MIR tab or Archived Cases: Import Section page > E2B (R2) tab appears.

Archived Cases - Export Section page

Note: Application displays 20 records per page based on the parameter configured in the ARISg Admin ESM > Setup > ESM Config.

Refer the following field description table for more information on the fields, icons and the tasks that you can perform on Archived Cases: Export Section page.

Archived Cases - Export Section page Field Description Table

Field	Description
S	The status of the cases. Following icons represents the status of the cases: Successful icon: Indicates that the exported case was received and loaded successfully by the recipient. Load with Error icon: Indicates that the exported case was received and loaded with error by the recipient Incomplete icon: Indicates that the exported case was incomplete. Parsing Error icon: Indicates that the recipient could not extract the exported case due to parsing error.
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. For example: IL-AER-097 (0.0). Click AER number link to view the AER details in the AER Details window. For more information, refer to Viewing AER Details section. 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.
Receiver	The name of the receiver organization who has received the current exported case.
Sent	The date on which the case is transmitted to the recipient.
ICSR MDN	In this field, you can view the date on which Message Disposition Notification (MDN) message is generated for the current case 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.Date	The Ack date on which the acknowledgment was received for the current case.
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 View	Click to view the acknowledgement details for the current case. Click to view the acknowledgment in XML view. For more information, refer to Viewing Acknowledgements Details section. Click to download the acknowledgement in XML format. Note: Application does not display acknowledgements for cases that are manually archived or archived on export.
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. Refer the Working with MHLW E2B Reports section for more information.
View	Opens the exported case in the following report format. Click to view the case in E2B xml format. Click to view the case in ICHE2B form view format. This option is not applicable for the archived eMDRs. For more information refer to Viewing ICSR Files.
A	The status of the attached document for a case. The following icons represents the status of the attached document: Successfully Processed - Indicates that the attached file was successfully processed. Partially Processed - Indicates that at least one of attached files was processed successfully, and processing of one or more attached files failed due to warning. Error - Indicates that the documents attached during the distribution were not processed and merged due to error. Warning Message - Indicates that the attachment was processed partially with warning message. Click the attachment icon to open the Attachment Details window. The attachment detail window displays the Safety Report Identification, MDN, Acknowledgement MDN, Attach icon, and Acknowledgement Icon for the attached document. Click respective link to view the Attach MDN, Ack MDN 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.
Note: If an automation rule is created with the parameter "archive on export" and "assigned to a receiver", then there are no acknowledgement entries for the cases. The cases are also listed in the archive section. For "archive on export" and "assigned to a receiver"cases, there is no transmission ack code value. A blank column is displayed in the listing of archive and ack.

Archived Cases - Import Section page

Refer the following field description table for more information on the fields, icons and the tasks that you can perform on Archived Cases: Import Section page > E2B (R2) tab.

Archived Cases - Import Section Field Description Table

Field	Description
T	Indicates that the case contains truncated data.
S	The status of the case. The icons representing the status of the cases are as follows: Successful icon: Indicates that the case was imported successfully. Load with Error icon: Indicates that the case was imported and loaded with error. Incomplete icon: Indicates that the imported case was incomplete. Parsing Error icon: Indicates that the imported case data was not extracted due to parsing error.
Message Number	The message number associated to the case. Click the message number link to view the message details in the AER Details window. For more information, refer to Viewing AER Details section. Note: The Message Number hyperlink is disabled if the imported case contains a 'Parsing Error'. The AER details are not available for such cases.
Sender	The name of the sender organization who has sent the imported case.
Received	The date on which the case was received for import.
ICSR MDN	In this field, you can view the date on which Message Disposition Notification (MDN) message is generated for the current ICSR file. Click MDN date link to view the MDN message on the MDN Message window. For more information, refer the Viewing MDN Messages section.
Ack Recv date	The Ack date on which the acknowledgement was sent. If the acknowledgment generated for the case is not exported to the sender and the Suppress ACK check box is selected for the sender company unit then the acknowledgment is marked as suppressed. The Suppressed Acknowledgment icon () displayed in this field to indicate that the acknowledgment is suppressed.
Ack MDN	The ACK-MDN is the official receipt date on which the acknowledgement message for the MDN was transmitted through the ESTRI Gateway.
Ack View	Click to view the acknowledgement details. Click to view the acknowledgement details XML view. For more information, refer to Viewing Acknowledgements Details section. Click to download the acknowledgement in XML format.
View	Opens the exported case in the following report format. Click to view the case in E2B xml format. Click to view the case in ICHE2B form view format. For more information refer to Viewing ICSR Files. Note: The icon is disabled if the imported case contains a 'Parsing Error'. The AER details are not available for such cases.

Note: When the user archives a transaction, before receiving MDN for ACK the system will not archive the transaction, and the particular transaction will neither be in ACK section nor in the Archived section. Once the MDN is received for the transaction then the transaction will be archived and it is available in archived section.