Reporting Destination

The following is the list of the J Specific Reporting Destination functionality changes:

The Argus Console > Code list > Reporting Destination > EDI (tab) has been enhanced:

  • The PMDA-DEVICE MESSAGE TEMPLATE standard device profile uses similar framework as E2B R3. This profile has elements related to both Form 8 and Form 10 XML report.
  • In the Message Profile drop-down list, the PMDA E2B R3 profile (ICH-ICSR V3.0 MESSAGE TEMPLATE - PMDA) is made available to the users for configuration.
  • In the ACK profile, users can select the PMDA E2B R3 Ack Profile.
  • The following fields in Reporting destination are populated with default values and displayed in the read-only for the PMDA E2B R3 profile (similar to the ICH E2B (R3) profile):
    • Encoding - UTF-8
    • XML Version - 1.0
    • Maximum # of reports to include in the msg-1
    • SGML (Disabled) / XML (Selected)
    • Identification Code (Agency Information and Local company contact Information)
    • Code Qualifier (Agency Information and Local company contact Information)
    • EDI header Required
    • URL for Message Schema and URL for Ack Schema
  • The EDI > Message Profile 2 drop-down list has been blanked and disabled for all the R3 Profiles including PMDA E2B R3 profile. (This drop-down list is only visible to a J user).

The Argus Console > Code list > Reporting Destination > Agency Information (tab) has been enhanced:

  • Check Agency Information > Authorized Representative, if you are an authorized representative.
  • Attachments under Report Transmissions is set as Single(default) and disabled.

To print these fields, go to Reporting Destination > Local Company Contact.