1. Japan User's Guide
  2. Transmit and Monitor ICSR Reports
  3. Transmit E2B Reports
  4. Nullification Reports

Nullification Reports

The system can automatically schedule, generate, and transmit a Nullification Report under the following circumstances:

  • When a case is deleted and an E2B Report is submitted to a reporting destination based on the Profile switch for sending E2B nullifications.
  • When an E2B report is submitted and marked as unsubmitted from Reports | Compliance | Submitted Reports:
    • The Reason for Unsubmitting the report is sent as the nullification reason for the report.
    • If the user selects the Send Nullification on Unsubmission of E2B Reports check box, the system also sends a nullification to the reporting destination where the E2B Report was previously submitted.
    • If the user does not select the Send Nullification on Unsubmission of E2B Reports check box, the system does not send a nullification to the reporting destination where the E2B Report was previously submitted unless the user deletes the case.
    • If a previous nullification for the E2B Report or an unsubmitted report is sent for a case and the case is deleted at a later date, the system does not send a duplicate nullification for the previous report.
    • When the system generates the Nullification report, the system updates the following E2B items with updated values from the previous report.
    Updated E2B Items Update Content

    M.1.4

    System uses a different unique number from that used in the last report.

    M.1.7a

    System enters the message date format.

    M.1.7b

    System enters the message date.

    M.2

    System increments this value every time it transmits the report.

    A.1.3a

    System enters the message date format.

    A.1.3b

    System enters the message date.

    A.1.13

    System enters 1=Yes on the Nullification report.

    A.1.13.1

    System enters the reason for the Nullification report.
  • When you accept a Nullification report, the system creates an Action Item in the case. The action item tells you that the system will delete the case if you click OK on the acceptance dialog for all unarchived cases.
    • Action Item is a type ahead field and its default is blank.
    • The field is populated with values from the action item configured in the code List.
    • You can assign the number of days until the action item is due in the Due In field. The system enables this field after you select an Action Item type.
    • The system calculates the due date as follows: System Date (local client date) + Due In number of days.
    • The system puts the System Date (local client date) in the Date field.
  • When creating the action item, you can select a value from the Code List and the Action Item Description. The system uses the following format: Nullification: xxx

    where:

    xxx is the value entered in the Notes field.

  • By default, the system assigns the action item to the user group in the User Group field.
    • There can be a maximum of 25 user groups in the drop-down list.
    • The system performs a like search when you select a value in the User Group field.
    • If the User Group field is blank, the system does not assign the action item.
    • This is enabled after you select an action item.
  • If you do not select an action item, the system does not create an action item for the case.
  • If you accept multiple cases, the system creates action items for all accepted cases.
  • The system skips open, locked, or archived cases or cases you don't have permission to access.
  • If the system archives a case while you are accepting the nullification report, the system displays the Archived Case dialog to enable you to open the archived case.
  • After you reopen the case, the system displays the Accept Nullification E2B dialog.
  • If you do not have permission to reopen an archived case, the system displays the following message:

    You do not have permission to Re-Open an archived/closed case.

  • PMDA E2B(R3) report transmits data in the nullification report based on the nullification report conformance for that element, only if that element is eligible to be transmitted in the Initial, FUP, Downgrade, or Amendment reports as per the conformance for that reporting category.

    For example, The Patient block (D) is not transmitted for the reporting category AE as the conformance is X = Do not enter. Hence, when a nullification report is generated for the reporting category AE, then the Patient block (D) is not transmitted.

  • In the PMDA E2B(R3) nullification report, you need to have at least one company product with a value populated in MHLWADMICSRNEWDRUGCLASS (J2.4.k).

    If the nullification report is generated due to a change of a company product with a Oracle Argus Safety Japan license by a company product without any Oracle Argus Safety Japan license, then the latest case data does not have any Oracle Argus Safety Japan product license listed in the PMDA tab with the MHLWADMICSRNEWDRUGCLASS (J2.4.k) value. The application fetches MHLWADMICSRNEWDRUGCLASS (J2.4.k) from the first drug block of the previously submitted E2B report for which nullification report is being generated.

Parent topic: Transmit E2B Reports