Suppress, Nullify, or Amend a Safety Report

Learn how to suppress submissions of a Case, and amend or nullify previous E2B Transmissions.

Sections in This Article

Overview

The following list provides an overview and links to topics covered in this article:

Suppress Submission
During case processing, you can Suppress Submissions of a Case Version when a case should be excluded from reporting to health authorities for both Submissions and aggregate or periodic reporting.
Nullification
When a previously transmitted ICSR is considered invalid, you can Nullify a Submission. You can also void a Case with the option of nullifying all previous transmissions. After nullifying Submissions, you can perform additional steps to Omit a Nullified Case from Aggregate Reports.
Amendment
When a previously transmitted ICSR contains information that must be changed, for example, to correct erroneous data entry or to retransmit attachments, you can Amend a Submission.

Note An amendment is different from a follow-up, which adds new information. Refer to E2B (R3) implementation guidance or your organizations standard operating procedures for more information.

Void
When a Case is logically deleted, the Case is considered void. A Case that was created by error, or a Case that a company will no longer submit follow-up information for, are instances of a voided Case.
Follow-Up
Additional information received for an AER past the initial submission.

See Case Processing Overview for more information on Voiding and Complete Case states.

Suppress Submissions of a Case Version

During case processing, if a case is considered invalid (for examples, see use cases), then you can select the Suppress Submission field to exclude that version of the Case from ICSR submissions and periodic reports.

Note An administrator may need to configure the Suppress Submissions feature, including adding the Suppress Submission field to the Case and AER page layouts.

Suppress Submission Field
Suppress Submission Field

What Happens When You Suppress Submissions

When Suppress Submission is flagged on a Case, the system adheres to the following behavior:

  • Submissions and Distributions: When the Evaluate Regulatory Obligations action runs, the system ignores Submissions for the Case, and only generates Distributions.

  • Aggregate Reporting: Aggregate report tabulations omit Case versions within the reporting period that have the Suppress Submissions field selected.

Suppress Submission Example Use Cases

Consider the following use cases where suppressing submissions for a Case may be useful:

  • The product associated with the case is not your company product.
  • A case that's missing valid ICSR criteria, such as patient or reporter information.
  • A case from literature that mentions your company but does not uniquely identify the exact product.
  • A case you receive from a partner for a non-company study, where the adverse event is not related to your product.

Amending or Nullifying Prior Submissions

You can amend previously transmitted E2B (R3) reports to include changes in information or correct errors. If an entire case has become invalid, you can nullify previously transmitted reports in either E2B (R2) or E2B (R3) format.

Consult your organization’s standard operating procedures to decide whether a change in information should result in an amendment or a nullification.

The following links provide amendment and nullification guidelines for EMA and FDA submissions:

Nullify a Submission

To nullify a previously submitted report, perform the following steps:

  1. From the Case page, go to the Transmissions section.
  2. Open the Transmission you wish to amend or nullify.
  3. Expand the All Actions (All Actions) menu, and then select Copy Record.
    The system copies the record to create a new Transmission record. You can also create a new Transmission and enter the details manually.
  4. Ensure that the File, Reason, and E2B Message ID fields are cleared.
    If these fields have been copied over, clear these fields manually and contact your administrator to correct your vault’s configuration.
  5. On the Create Transmission page, complete the following fields and then select Save:
    • Reason: Select Nullification to report a case as nullified.

    • Reason Text: Enter more information about the reason for the nullification.

    • E2B Message ID: Enter a new message ID to use in the E2B message header.

  6. Expand the All Actions (All Actions) menu, and then select Generate Transmission Document(s).
  7. Proceed to send the transmission to the destination gateway.

Omit a Nullified Case from Aggregate Reports

To omit a Case considered nullified from aggregate reporting, perform the following steps:

  1. Nullify all Submissions associated with the Case.
    Each nullification Transmission record must meet the following requirements:
    • The Reason field must be set to Nullification.
    • The Submission record must be in the ACK Accepted or Completed lifecycle state.
  2. Move the Case to the Nullified lifecycle state.
    Once a Case enters the Nullified state, it is locked to prevent further processing.

    Note An administrator may have configured a user action or workflow to change the Case state to Nullified. Consult your organization's standard operating procedures for guidance.

Result

Once a nullification has been completed, upon moving the Case lifecycle to the Nullified state, the system automatically selects the Suppress Submission field on the current version of the Case.

For future generated aggregate reports, the current version of the Case and previous versions within the aggregate reporting period are excluded.

Amend a Submission

To amend a previously submitted report, perform the following steps:

  1. From the Case page, go to the Transmissions section.
  2. Open the Transmission you wish to amend or nullify.
  3. Expand the All Actions (All Actions) menu, and then select Copy Record.
    The system copies the record to create a new Transmission record.
  4. Ensure that the File, Reason, and E2B Message ID fields are cleared.
    If these fields have been copied over, clear these fields manually and contact your administrator to correct your vault’s configuration.
  5. On the Create Transmission page, complete the following fields and then select Save:
    • File: Select the new ICSR file you want to submit.

    • Reason: Select Amendment to amend a prior submission.

    • Reason Text: Enter more information about the reason for the amendment.

    • E2B Message ID: Enter a new message ID to use in the E2B message header.

  6. Expand the All Actions (All Actions) menu, and then select Generate Transmission Document(s).
  7. Proceed to send the transmission to the destination gateway.

Void a Case

You can use the Void Case action from the All Actions menu to logically delete a Case and (optionally) nullify all previous transmissions at the Case-level. When you initiate the Void Case action, the system will automatically cancel any In-Progress Case workflows.

Note that void and logically delete are interchangeable terms. Vault Safety uses the term “void”, although logically delete is more widely used in the industry. You can re-label the action and state names accordingly for the customer.

When you choose to nullify previous transmissions, you can enter the nullification reason text that will be copied to all system-generated transmission records relevant to the Case. The system will automatically generate Transmission records for all previously submitted destinations.

Note The Void Case user action is only available for the latest Case version. Any state changes (for example, to Voided or Nullified state) only apply to the latest Case version as well. The system also prevents this action when there is more than one active version for the Case.

Prerequisites

Administrators must enable Case nullification in order to run the Void Case user action.

Void a Case with No Previous Transmissions

To void a Case with no previous transmissions:

  1. Navigate to the Case you want to void.
  2. Expand the All Actions (All Actions) menu, and then select Void Case.
    The Case is moved to the Voiding state and must be reviewed before transitioning to the Voided state.
  3. Select Complete beside Voiding of Case.
    The Review Voiding of Case window is displayed.
  4. Complete all of the fields to finalize the review.
  5. Select Complete.
    The Case is successfully voided and moved to the Voided state.

Void a Case and Nullify all Previous Transmissions

To void a Case with previous transmissions:

  1. Navigate to the duplicate Case you want to void.
  2. Expand the All Actions (All Actions) menu, and then select Void Case.
    The Nullification details window appears.
  3. Select Yes from the Nullify Transmissions field.
  4. Enter the nullification reason in the Reason (Text) field.
  5. Select Continue.
    The Case enters the Nullifying state.

Result

The system auto-generates transmission records with the entered nullification reason text to all previously submitted destinations.

If the Transmission profile has the Auto-Submit value set to Yes, the Case can be configured to auto-submit once the Case enters the Nullifying state. Otherwise, the Case will remain in the Nullifying state until there is a receipt of positive ACKs and completion of all transmissions.

Void a Case and Submit One Last Time

  1. Navigate to the duplicate Case you want to void.
  2. Expand the All Actions (All Actions) menu, and then select Void Case.
    The Case is moved to the Voiding state and must be reviewed before transitioning to the Voided state.
  3. Select Complete beside Voiding of Case.
    The Nullification details window appears.
  4. Select No (Submit one last time) from the Nullify Transmissions field.
  5. Enter the nullification reason in the Reason (Text) field.
  6. Select Continue.

Result

The system automatically cancels any existing workflows and the Case state transitions to Voiding. The system also automatically creates follow-up transmission records with the entered nullification reason text to all previously submitted destinations.

When the transmissions have been completed, the Case state will be moved to the Logically Deleted state.

Audit Log for Case Voiding

Any Void Vase actions and workflow cancellations are captured in the audit trail during Case voiding.

If the “Workflow cancellation comment” for the Case Voiding workflow is enabled and the system cancels an in-progress workflow, the audit trail logs this cancellation as “System”, with a system-generated comment, “Cancelling in-progress workflow to void the case”.

See Audit Case History for more information on the Case audit trail.


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