6 Importing E2B Reports

Incoming E2B Reports

Incoming E2B Reports can be viewed from the Incoming E2B Report screen. This section includes discussions on the following:

• Searching for Duplicate Cases

• Using the View Differences Report

• Viewing the E2B Report

• Accepting Single/Multiple E2B Reports

Searching 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 -> E2B 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.

Duplicate Search Dialog Box Fields

The following table describes the fields present in the Duplicate Search dialog.

Field	Description
Agency	The name of the primary agency.
Original Case Number	The submitter's original case number.
Message Number	The case message number.
Product Name	The name of any product on XML.
Generic Name	The active substance on XML.
Report Type	The type of report.
Study ID	The unique value that identifies the study.
Receipt Date	The date Argus received the report and saved it in the system.
Center ID	The ID of the center.
Sal.	The salutation, such as Mr. or Mrs.
Suffix	The suffix, if applicable, that follows the name (e.g., Jr., Sr.,III, etc.)
First Name	The first name of the patient.
Last Name	The last name of the patient.
Country of Incidence	The country where the incident occurred.
State	The state where the incident occurred.
Postal Code	The postal code of the area where the incident occurred.
Patient Name	The name of the patient.
Event Desc.	A description of the adverse event.
Initials	The initials of the patient.
Onset Date	The date from the first reaction or adverse event occurred.
Pat. ID	The unique value that identifies the patient.
Age/Units	The age of the patient.
Pat. DOB	The patient's date of birth.
Gender	The gender of the patient.
Reference #	National Regulatory Authority's Report Number, used as a Reference Number.
Journal	The journal name of the literature reference.
Keyword	Select the check box and enter a keyword to be searched, if required.
Title	Select the check box and enter a title to be searched, if required.
Nullification Reason	The reason the case was nullified.
Accept Initial E2B as Follow-Up	Enables you to accept initial E2B as a follow-up to an existing case.
Search	Finds results matching the specified search criteria.
View E2B	Enables you to view the E2B report.
Accept E2B Case	Enables you to accept an E2B case.
Reject E2B Case	Enables you to reject an E2B case.
View Warning	Enables you to view warnings associated with the case.
View Differences	Enables you to view the differences between the XML to be imported (a message that is not yet imported into the database), the current case data in the database, and the last imported case. Note: This button is available only for follow-up and nullification reports.
Case Number	The case number of the case matching the search criteria.
Pat. Initials	Displays the initials of the patient in the case matching the search criteria.
Action	Enables you to view the Case Summary dialog.
Project ID	Displays the Project ID of the case matching the search criteria.
Study ID	Displays the Study ID of the case matching the search criteria.
Date	Displays the date of the case matching the search criteria.
Country	Displays the country name of the case matching the search criteria.
Product	Displays the product name involved with the case matching the search criteria.
Event	Displays the event involved with the case matching the search criteria.
Report Type	Displays the report type of the case matching the search criteria.
Reporter	Displays the reporter involved with the case matching the search criteria.

Note:

The search output is displayed in the Total Number of Rows section. You can click the Action icon to view the Case Summary dialog.

Using 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:

Field	Description
Trading Partner	Enables you to view the name of the Trading Partner sending the E2B report. Note: The Lock/Archive icon displayed with this field indicates the status of the case.
DTD Version	Enables you to view the DTD version of the follow-up E2B report.
Case Number	Displays the sender's original case number for the E2B report.
Follow Up #	Displays the sequence number of the follow-up for the E2B report.
Total Number of Rows	Allows you to select the type of E2B Difference to view from: Current E2B vs. Current Case in Database Current E2B vs. Last Imported E2B Current Case in Database vs. Last Imported E2B
Import	This check box highlights import differences.
E2B Element	Refers to the data elements in the incoming E2B report or in the existing report.
Current E2B	Refers to the data in the incoming XML that has not yet been accepted in the current E2B.
Current Case in Database	Refers to the data in the current case in the database.
Last Imported E2B	Refers to the data showing the last imported E2B.
Accept Follow-up	Allows you to accept follow-up reports with the corresponding fields selected for import.
Reject Follow-up	Enables you to reject follow-up reports for import.
Print List	Provides the difference report in a PDF format.
Close	Enables you to close the window.

Displaying Differences

The differences in the E2B reports are displayed in the following manner:

• Addition - New elements on incoming XML are highlighted in grey.

• Deletion - Deleted elements are highlighted in red.

• Modification - Modified elements are highlighted in yellow.

Viewing 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 E2B Viewer. You can also view an E2B report from the E2B Pending screen by right-clicking on a row and selecting ICSR Viewer.

Accepting Single/Multiple E2B Reports

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

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

2. When the system opens the E2B Pending screen:

   To accept a single report, right-click on it and select Accept E2B

   OR

   To accept multiple reports, select the check boxes for each report and click Accept E2B.

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:

   The acceptance of multiple E2Bs 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.

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 accept 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.

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

• 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 #: XXXXX

  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.

• 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.

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 case is in archived state while you are accepting the report, the system displays the Case Re-open dialog to enable you to open the case.

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

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

• If 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.

Processed E2B Reports

The Processed E2B Reports screen contains a list all processed E2B Reports. Click the Processed E2B Reports tab on the Incoming Reports screen to view the Processed E2B Reports screen.

The Processed E2B screen contains the following:

• Search Criteria

• Total Number of Rows

The following table lists and describes the fields in the Total Number of Rows section on the Processed E2B screen.

Field	Description
Originated Case#	Displays the Originated Case Number of the case.
Initial/F-U/Nullification	Displays the Initial/F-U/Nullification status.
Trading Partner	The name of the trading partner.
World Wide Unique#	The World Wide Unique # for the case.
Import Status - Warnings/Errors	The import status of the case and any associated warnings/errors.
Case # Imported As	The Case Number used when importing the case.
Accepted / Rejected By	Identifies who accepted or rejected the case.
Notes	The case notes.
Interchange Date	The Interchange Date.
Date Imported/Rejected	The date the case was imported/rejected.
ACK Gen	Yellow indicates the case is still pending Orange indicates the case is accepted with warnings / errors Red indicates the user or system rejected the case. Green indicates the case has been successfully imported.
EDI Out	Yellow indicates the system is waiting to send the report out of the EDI / XML or PHY out folders Green indicates the report is already sent out of the EDI / XML or PHY out folders Red indicates that the EDI gateway failed to send the report out of the EDI / XML or PHY out folders.