Generating Transaction Report

You can generate the transaction reports for exported or imported cases based on the Status, Report Criteria, Transaction status, Transmission between Dates, receiver, and sender criteria.

To generate transaction reports:

In the ARISg user menu bar, click ESM menu > Reports section > Transaction Report.

The Reports: Transaction page appears.

Reports - Transaction Page, Selection criteria report

Click the E2B (R2), E2B (R3), eMDR (R2), eVAER (R3) or MIR tab to generate the transaction report of the cases corresponding to E2B (R2), E2B (R3), eMDR (R2) or eVAER (R3) format respectively.
Refer the following field description table to enter or select various fields available on the Reports: Transaction page > E2B (R2), E2B (R3), eMDR (R2), eVAER (R3) or MIR tab.

Reports - Transaction Field Description Table

Field	Description
Status	In this field, you can select the value to generate transaction report for active or archived cases. The available options are: Active: Select this option to generate the transaction report for the cases that are currently active in agXchange ESM. Archived: Select this option to generate the transaction report for the cases that are currently archived in agXchange ESM. Active and Archived: Select this option to generate the transaction report for both active and archived cases in agXchange ESM. Note: By default, 'Active and Archived' is displayed.
Reports Criteria	Select one of the following options to generate transaction report for exported or imported cases: Export: Select this option to generated transaction report for exported cases corresponding to E2B (R2), E2B (R3) or eMDR (R2) format. Import: Select this option to generated transaction report for imported cases corresponding to E2B (R2) format. Note: By default, 'Export' is displayed.
E2B Acknowledgement Status	In this field, you can select the option to generate the report based on the E2B acknowledgement status. The available options are: No Acknowledgement (this option is displayed only for export cases): Select this option to generate report for the export cases for which acknowledgement is never received. Not yet received (this option is displayed only for export cases): Select this option to generate report for the export cases for which acknowledgement is not yet received. All Reports Loaded into Database: Select this option to generate report for the export or import cases for which safety reports are successfully loaded into ARISg database. ICSR Error, not all Reports Loaded into Database: Select this option to generate report for the export or import cases for which safety reports are loaded into ARISg database with error. SGML/XML parsing error, no data extracted: Select this option to generate report for the export or import cases for which no data is extracted due to parser error.
Message Type	Select the message type based on which you want to generate the report for export or import cases. The available options are: All : By default this option is displayed and will generate the report for cases with ALL message type. ichicsr: Select this option to generate the report for the cases with ichicsr message type. backlog: Select this option to generate the report for the cases with backlog message type. backlogct: Select this option to generate the report for the cases with backlogct message type. psur: Select this option to generate the report for the cases with psur message type. ctasr: Select this option to generate the report for the cases with ctasr message type. cticsr: Select this option to generate the report for the cases with cticsr message type. dsuricsr: Select this option to generate the report for the cases with dsuricsr message type. camricsr: Select this option to generate the report for the cases with camricsr message type. sapicsr: Select this option to generate the report for the cases with sapicsr message type. 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. This filed is not available on the Reports: Transaction page > eMDR (R2) and eVAER (R3) tab.
MDN Status (this field is displayed only for export cases)	Select the MDN status based on which you want to generate the report for export cases. The available options are: Not yet received MDN: Select this option to generate the report for the export cases for which MDN is yet to be received. Received MDN: Select this option to generate the report for the export cases for which MDN is received.
Message Number (this field is displayed only for export cases)	Enter the message number of the case for which you want to generate the transaction report.
AER Number (this field is displayed only for export cases)	Enter the AER number of the case for which you want to generate the transaction report.
Reported Term (this field is displayed only for export cases)	Enter the reported term to generate the transaction report for the cases that are associated with the specified term.
Product (this field is displayed only for export cases)	Enter the name of the medicine, medicinal product or medical device to generate the transaction report for the cases that are associated with the specified product.
Protocol (this field is displayed only for export cases)	Enter the protocol name to generate the transaction report for the cases that are associated with the specified protocol.
Primary Source Country (this field is displayed only for export cases)	Select the primary source country where the adverse event case is first registered. Application generates the report for the cases that are associated with selected primary source country.
Recipient	Enter the name of the receiver unit who receives the case. Application generates the report for the cases for which specified recipient is set as receiver. Only the transmissions made to that recipient are considered.
Sender	Enter the sender unit name who transmits the case. Application generates the report for the cases for which specified sender is set as sender unit. Only the transmissions made by the sender organization are considered.
Date Distributed (this field is displayed only for export cases)	Under this section, select the date range in the From Date field and To Date field to generate report for the cases that are distributed (from ARISg) between the selected date range.
Date Informed (this field is displayed only for export cases)	Under this section, select the date range in the From Date field and To Date field to generate report for the cases for which informed authority date is updated between the selected date range.
Received Date (this field is displayed only for import cases)	Under this section, select the date range in the From Date field and To Date field to generate report for the cases received (from authority or business partner) between the selected date range.
Seriousness (fields under this section are displayed only for export cases)
Death?	Select the seriousness from the following options: Yes: Select this option to generate the report for the cases for which seriousness is set to Yes for the Resulted in Death? field. No: Select this option to generate the report for the cases for which seriousness is set to No for the Resulted in Death? field.
Life threatening?	Select the seriousness from the following options: Yes: Select this option to generate the report for the cases for which seriousness is set to Yes for the Life threatening? field. No: Select this option to generate the report for the cases for which seriousness is set to No for the Life threatening? field.
Disability or permanent damage?	Select the seriousness from the following options: Yes: Select this option to generate the report for the cases for which seriousness is set to Yes for the Disabling/Incapacitating? field. No: Select this option to generate the report for the cases for which seriousness is set to No for the Disabling/Incapacitating? field.
Congenital anomaly/Birth Defect	Select the seriousness from the following options: Yes: Select this option to generate the report for the cases for which seriousness is set to Yes for the Seriousness Congenital? field. No: Select this option to generate the report for the cases for which seriousness is set to No for the Seriousness Congenital? field.
Hospitalization	Select the seriousness from the following options: Yes: Select this option to generate the report for the cases for which seriousness is set to Yes for the Caused/Prolonged Hospitalization? field. No: Select this option to generate the report for the cases for which seriousness is set to No for the Caused/Prolonged Hospitalization? field.
Other Serious (Important Medical Events)	Select the seriousness from the following options: Yes: Select this option to generate the report for the cases for which seriousness is set to Yes for the Other Seriousness? field. No: Select this option to generate the report for the cases for which seriousness is set to No for the Other Seriousness? field.

Note: Transactions awaiting acknowledgement are not displayed in the Transaction Reports.

Click Generate.

The Reports: Transaction listing page > E2B (R2), E2B (R3), eMDR (R2), eVAER (R3) or MIR tab appears with a list of cases retrieved based on the specified criteria.

Below is a sample of the Reports: Transaction listing page for import cases:

Reports - Transaction Listing - Import Cases

Below is a sample of the Reports: Transaction listing page for Export cases:

Reports - Transaction Listing - Export Cases

Note: Application displays the MDN field if Cyclone Interchange is selected as ESTRI Gateway.

Refer the following field description table for more information on the fields, icons and the tasks that you can perform on Reports: Transaction listing page > E2B (R2), E2B (R3), eMDR (R2), eVAER (R3) or MIR tab.

Reports - Transaction Field Details Table

Field	Description
S	The status of the cases. Following icons represents the status of the cases: Successful icon: Indicates that the case was loaded into database successfully. Load with Error icon: Indicates that the case was loaded into the database with error. Incomplete icon: Indicates that the case was incomplete. Parsing Error icon: Indicates that the case data was not extracted due to parsing error.
AER Number (Ver. Loc Ver) or Message Number	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. or The message number associated to the case. Click AER number or message number link to view the AER details in the AER Details window. For more information, refer to Viewing AER Details section. Note: Application displays 'Message Number' if the 'Report Criteria' is specified as 'Import'. The message number link is disabled for an Imported case with Load Status as 'Parsing Error', as no AER details are available for such a case. When a record contains more than one AER, then the first AER Number is displayed followed by [+] sign.
Receiver or Sender	The name of the receiver organization who receives the case. Or The name of the sender organization who has sent the imported case. Note: Application displays 'Sender' if the 'Report Criteria' is specified as 'Import'.
Sent Or Received	The date on which the ICSR is sent. Or The date on which the case was received for import. Note: Application displays 'Received' column if the 'Report Criteria' is specified as 'Import'.
ICSR MDN	The ICSR MDN is the official receipt date on which the safety message is successfully transmitted to the authorities through the ESTRI Gateway.
Ack Date	The Ack date on which the acknowledgment was received for the exported case. Or The Ack date on which the acknowledgment was sent for the imported case.
File	Opens the 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.
Ack	Click to view the acknowledgement details for the current case. For more information, refer to Viewing Acknowledgements Details section.
Details	Click to view the transaction history for the case. For more information, refer the Viewing Transaction History section.

Click to view the printable version of the report.

Transaction Report (Printable version)

To print the report, click .

Click at the top left corner of Reports - Transaction Listing page.

The Transaction Report page in PDF format appears.

Transaction Report - PDF View, Page 1

Transaction Report - PDF View, Page 2

Mapping of Data on the Transaction Report

The mapping of data on the Transaction Report is described in the following table:

Report Column/ Field Name	Referenced Table/ Field	Page / Field Name	Description
Status	Not Applicable	Reports: Transaction/ status	The 'Archived' status of the transactions is printed. Note: Only acknowledged cases are considered.
Report criteria	Not Applicable	Reports: Transaction/ Report criteria	The report criteria is printed.
Transaction status	Not Applicable	Reports: Transaction/ Transaction status	The status of the transaction is printed.
Receiver	Not Applicable	Reports: Transaction/ Receiver	The name of the receiver is printed.
Sender	Not Applicable	Reports: Transaction/ Sender	The name of the sender is printed.
Date Submitted (from)	Not Applicable	Reports: Transaction/ Transmission between	The period for which the report is generated, is printed.
Date Submitted (To)	Not Applicable	Reports: Transaction/ Transmission between	The period for which the report is generated, is printed.
Message Number	Active and Archived: E2B_ICSR_ARCHIVE/ MESSAGE_NUMBER E2B_MESSAGE_QUEUE/ MESSAGE_NUMBER Archived: E2B_ICSR_ARCHIVE/ MESSAGE_NUMBER Active: E2B_MESSAGE_QUEUE/ MESSAGE_NUMBER	Not Applicable. The data displayed in this field is extracted internally and displayed in the report.	The message number is printed.
ICSR	Not applicable	Not Applicable. The data displayed in this field is extracted internally and displayed in the report.	The count of AERs in a particular message number, is printed.
Receiver	Active and Archived: E2B_ICSR_ARCHIVE/ RECEIVER_NAME E2B_ORGANIZATION/NAME Archived: E2B_ICSR_ARCHIVE/ RECEIVER_NAME Active: E2B_ORGANIZATION/NAME	Not Applicable. The data displayed in this field is extracted internally and displayed in the report.	The name of the receiver is printed.
Sender	Active and Archived: E2B_ICSR_ARCHIVE/ SENDER_NAME E2B_ORGANIZATION/NAME Archived: E2B_ICSR_ARCHIVE/ SENDER_NAME Active: E2B_ORGANIZATION/NAME	Not Applicable. The data displayed in this field is extracted internally and displayed in the report.	The name of the sender is printed.
Date Sent or Date Rcvd	Active and Archived E2B_ICSR_ARCHIVE/ TRANSMISSION_DATE E2B_MESSAGE_QUEUE/ TRANSMISSION_DATE Archived: E2B_ICSR_ARCHIVE/ TRANSMISSION_DATE Active: E2B_MESSAGE_QUEUE/ TRANSMISSION_DATE	Not Applicable. The data displayed in this field is extracted internally and displayed in the report.	The date on which the ICSR is sent or received, is printed. Note: 'Date Rcvd' is displayed if the 'Report Criteria' is specified as 'Import'.
Ack. Rcvd. Date	Active and Archived E2B_ICSR_ARCHIVE/ E2B_MESSAGE_ACK/ ACK_MESSAGE_DATE Archived: E2B_ICSR_ARCHIVE/ Active: E2B_MESSAGE_ACK/ ACK_MESSAGE_DATE	Not Applicable. The data displayed in this field is extracted internally and displayed in the report.	The date on which the acknowledgement is received or sent, is printed. Note: Ack.Sent Date is displayed if the 'Report Criteria' is specified as 'Import'.
Status	Active and Archived: E2B_ACK_ARCHIVE/ TRANSMISSION_ACK_CODE E2B_MESSAGE_ACK/ TRANSMISSION_ACK_CODE Archived: E2B_ACK_ARCHIVE/ TRANSMISSION_ACK_CODE Active: E2B_MESSAGE_ACK/ TRANSMISSION_ACK_CODE	Not Applicable. The data displayed in this field is extracted internally and displayed in the report.	The load status of ICSR as specified in the Acknowledgment, is printed.
Archived	Active and Archived E2B_ICSR_ARCHIVE. ARCHIVE_DATE Archived: E2B_ICSR_ARCHIVE. ARCHIVE_DATE Active: Not applicable	Not Applicable. The data displayed in this field is extracted internally and displayed in the report.	The date on which the transaction is archived, is printed. Note: For 'Active' cases, this field is blank.
Archived by	Active and Archived: E2B_ICSR_ARCHIVE/ USER_ID_ ARCHIVE Archived: E2B_ICSR_ARCHIVE/ USER_ID_ ARCHIVE Active: Not applicable	Not Applicable. The data displayed in this field is extracted internally and displayed in the report.	The 'User ID' of the user who archived the transaction, is printed. Note: For 'Active' cases, this field is blank.

Viewing Transaction History

On the Reports - Transaction listing page > E2B (R2), E2B (R3), eMDR (R2), eVAER (R3) or MIR tab, you can view the transaction history for the imported or exported cases.

To view the transaction history:

Click in the Details column for a case.

The Transaction history page appears.

Transaction History

Transaction History Field Details Table

Field	Description
Message number	The message number associated to the case.
Sender	The name of the sender organization who transmitted the case.
Receiver	The name of the receiver organization who receives the case.
Message Sent Date Or Message Received Date	The date on which the message is sent or received. Note: Application displays 'Message Received date' if the 'Report Criteria' is specified as 'Import'.
MDN Received	The date on which MDN is received.
Acknowledgement Received Date Or Acknowledgement Sent Date	The date on which the acknowledgement is received or sent. Note: Application displays 'Acknowledgement sent Date' if the 'Report Criteria' is specified as 'Import'.
Load Status	Indicates if the ICSR or eMDR file is successfully loaded, loaded with error or not loaded due to parsing error..
Archive Date	The date on which the case is archived.
User Archived	The unique identification of the user who archived the case.
E2B Message Type	The type of E2B message that the case is associated with. This field is not applicable for the export cases (MDRs) corresponding to eMDR (R2) format.
Number of Cases Sent	The number of AERs associated with the message.
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.
Version	The AER version number for the case.
ARIS Distribution Date	The date on which the case is distributed from ARISg.
Distributed By	The name of the user who distributed the case from ARISg.

Note: For an imported case, the 'Number of cases sent' table is not displayed if the 'Load Status' of the ICSR is 'Parsing Error'. No AER details are available for such a case.