Reviewing an Export Case

This section explains about the various aspects of reviewing a case before submitting the case to the recipient or an authority.

Reviewing AER Details

On the Export Section page > E2B (R2), E2B (R3), eMDR (R2), eVAER(R3) or MIR tab, click the AER Number link. You can view the AER details for a case in the AER Details window.

AER Details Window

AER Details - Field Description Table

Field Name

Description

Message Number

The message number associated to the case.

A message number is a unique identification number generated for the AER cases, by the application that can contain multiple safety report records or medical device report records. The Message number is a reference for the corresponding AER number and the safety report or device report.

ESM Server generates the message number for each ICSR/ICSRACK and eMDR/eMDRACK files in the following format:

<Account Name><Running Oracle Sequence>

<messagenumb>PFZ0000000001234</messagenumb>

For Example:

If 'PFZ' is the account name for an E2BService and '0000000001234' is the Oracle sequence for the current operation, then the message number generated is 'PFZ0000000001234'.

Number of AERs

The total number of AERs (Safety reports or device reports) associated with the message number.

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).

AER number is automatically generated during data entry in ARISg. The number uniquely identifies an AER in ARISg, and is automatically generated or manually entered based on the option set by the company, while setting the installation parameters in ARISg Administration section.

Ver

The latest version number of the case.

Product Name

The name of the medicine, medicinal product or medical device due to which the adverse event reaction occurred.

Event

The reported term for the adverse event of the case.

Seriousness

The severity of the case.

Latest Received Date

The date on which the safety report is received from ARISg.

 

Reviewing Receiver Details

You can view the information of the receiver who received the case.

  1. In the Export Case page > E2B (R2), E2B (R3), eMDR (R2), eVAER(R3)  or MIR tab, click.
    The Receiver’s Detail page appears.

Receivers Details

  1. To return to the Export Section page, click Close.

Receiver’s Field Details Table

Field

Description

Name

The name of the recipient who receives the case. The recipient can be a regulatory authority or a business partner.

Title

The title of the receiver who receives the case.

Type

The profession of the receiver.

The receiver can be any one of the following types:

  • Distributor

  • Health professional

  • Partner

  • Pharmaceutical Company

  • Regional Pharmacovigilance Center

  • Regulatory Authority

  • WHO Collaborating Center for International Drug Monitoring

Organization

The name of the organization to which the receiver belongs.

Note: System will display "Unit Name (Japanese)" for Japanese cases in export listing.

Department

The name of the department in the organization, to which the receiver belongs.

Address

The address of the receiver.

Phone

The phone number of the receiver.

Phone Country Code

The country code of the phone number.

Fax

The fax number of the receiver.

Fax Country Code

The country code for the fax number of the receiver.

Email Address

The email address of the receiver.

  1. To return to the Export Section page, click Close.

Application displays the following page when case is not available for export.

Export - Error Message Page

Note: Application allows only a single case export for MHLW distribution.