Reclassifying a Case

In the ESM module, before importing a case to ARISg database, you can reclassify a classified E2B case (case that is already classified by the application automatically) manually by providing a valid AER number of the existing case in ARISg. For example, when a particular E2B case is received in ESM Server and classified automatically as Initial case, and the user finds that the case is a follow-up of the existing case then the user can reclassify this case as follow-up to the existing case in ARISg by providing the AER number of the existing case.

For the cases that are reclassified to Follow-up or Duplicate, you must provide the AER number of the existing case in ARISg. For cases the are reclassified to Initial, the AER number is generated automatically by the application.

Note: You can reclassify the case manually only if you have access privilege for the Import View. The access privilege for Import View is set in the ARISg Admin (ARISg Admin > Security menu > Roles & Privileges > ESM tab > Screen Privileges section). For more information on setting the ESM roles and privileges, refer the ARISg Administrator's guide.
Manual reclassification is not applicable for Error cases.

For more information on automatic case classification, refer the Automatic Case Classification in ESM Server section.

When you perform manual reclassification for a classified case, the original classification identity (Automatic classification performed by the application) of the case is lost as the Company Number (CN) and Authority Number (AN) is copied from the AER number of the selected case to the reclassified case.

If you manually re-classify a case received through EDC, the value in the Other field (AER.OTHER_NUMB column) of the selected AER is used (that is, World Wide ID is copied) for reclassification instead of value in Company Number (CN) and Authority Number (AN) columns.

You also can reclassify a case that is already reclassified manually. For example, if you select a case 'A' that is Follow-up to AER1 and you reclassify case 'A' as Duplicate to AER2 then you also can reclassify the case 'A' as Follow-up to AER1.

The possible reclassification options for a received E2B case are:

• Reclassification from Initial to Follow-up

• Reclassification from Initial to Duplicate

• Reclassification from Follow-up to Initial

• Reclassification from Follow-up to Duplicate

• Reclassification from Duplicate to Initial

• Reclassification from Duplicate to Follow-up

• Reclassification from Follow-up to Existing

You also can reclassify a Duplicate case of one AER to Duplicate of another AER and Follow-up case of one AER to Follow-up of another AER.

Note: When you reclassify a initial case to a follow-up case, if a follow-up case is received for the reclassified case then the received follow-up case is classified as Initial case.
During the second level import for a case reclassified as Follow-up, the application does not perform the automatic classification. Instead, the application uses the classification set during the case reclassification and CN/AN of the ICSR file is not imported to ARISg database. For example, if you reclassify as a classified case (That was classified as Initial) as Follow-up and import the case to ARISg then the application uses Follow-up as the case classification.
If a case is reclassified as a Follow-up of an existing AER that has both CN and AN then the new version created after second level import also have same CN and AN. But, the acknowledgement generated for this case contains only the AN.
During the second level import for a case reclassified as Duplicate, the application does not perform the automatic classification. The case is imported as Duplicate instead of importing as Follow-up, and CN/AN of the ICSR file is not imported to ARISg database.
During the second level import for a case reclassified as Initial, the application does not perform the automatic classification. The case is imported as Initial, and CN/AN of the ICSR file is not imported to ARISg database.

To reclassify a case:

1. From the ARISg menu, click ESM > E2B import section > Import Section.
   The Import Section page > E2B (R2) tab appears.

Import Section Page

2. Click for the safety report that you want to reclassify.

The Re-Classification page appears. On this page, you can view the current classification and AER number for the selected case.

Re-Classification page

3. Refer the following field description table for more information on the fields and the task that you can performs on this page:

Re-Classification page Field Description Table

4. From the Classification drop-down, select the classification category to reclassify the current case with the selected AER number.

Note: As the AER number is generated automatically for a Initial cases, the Search fields and the Selected AER Number field are not displayed if you select Initial option from the Classification drop-down.

5. In the AER Number field, enter the AER number of the existing case in ARISg to which the selected case must be reclassified and click Search.

Or

Click Search to view and select the AER number from the available cases in ARISg.

The latest version of the approved AERs with the receipt date less than or equal to the receipt date of the current case are displayed from the ARISg database.

For example, if the receipt date case A and B is August 7, 2011, receipt date of case C and D is August 9, 2011, and receipt date of case E is August 10, 2011 and you select case D for reclassification then search result display the AERs of cases received on August 9, 2011 (case C) and cases received before August 9, 2011 (case A and B). The case E is not displayed as the receipt date of case E is greater than the case D.

Re-classification page- Search Result

6. Click select link for the AER number to which you want to reclassify the case.

The selected AER number is displayed in the Selected AER Number field.

7. Click Re-classify to reclassify the case to the selected classification category with the selected AER number.

Confirm Re-classification dialog appears.

Confirm Re-Classification dialog

8. In the Confirm Re-classification dialog, enter the valid reason for reclassifying the case manually and click OK to reclassify the selected case.

After reclassifying the safety report or message, the message "Successfully Re-Classified" is displayed with Details link at the top left corner of the Import Section page.

9. Click the Details link to view the details of the message and the associated safety reports that are successfully reclassified.

The reclassified case is displayed on the Import Section page > E2B (R2) tab and in the reclassification column, the reclassified icon () is displayed for the case.

For the cases reclassified to Follow-up or Duplicate, the original Company number (CN) or Authority number (AN) of the received E2B case is removed and the CN or AN from the selected AER number is copied.

If the selected AER number has multiple AER version then the CN or AN is copied from the latest AER version that contains CN or AN. For example, if the selected AER number has three version, and Version 0 contains CN or AN, version 1 also contains CN or AN, and version 2 does not contain CN or AN then the CN or AN is copied from the Version 1.

If the selected AER number does not contain CN/AN then the CN/AN from the received ICSR file is used in the new version of the selected AER.