# Suppress, Nullify, or Amend a Safety Report

Learn how to suppress _Submissions_ of a _Case_ and amend or nullify previous E2B _Transmissions_. 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][1] when a _Case_ should be excluded from reporting to health authorities for both _Submissions_ and all aggregate reporting.
* **Nullification**: When a previously transmitted ICSR is considered invalid, you can [nullify a _Submission_][2]. After nullifying _Submissions_, you can perform additional steps to [omit nullified _Cases_ from PADER aggregate reports][3].
* **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_][4].

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      <p><strong>Note</strong>: An amendment is different from a follow-up, which adds new information. Refer to E2B(R3) implementation guidance or your organization’s standard operating procedures for more information.</p>
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* **Void**: When a _Case_ is [logically deleted][5], the _Case_ is considered void. Examples of when to void a _Case_ include when a _Case_ was created in error, and when a company will no longer submit follow-up information for a _Case_. For a _Case_ with previous _Transmissions_, you have the option to transmit the _Case_ one last time and then mark the _Case_ as Voided (see [Void a Case and Nullify all Previous Transmissions][6]).

* **Follow-Up**: Additional information about a _Case_ that was received after the initial submission.

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      <p><strong>Note</strong>: You cannot create a follow-up <em>Case</em> from a <em>Case</em> that has been nullified or voided.</p>
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See <a href="/en/gr/01171/#voiding">Case Processing Overview</a> for more information on _Case_ states.

## Suppress Submissions of a Case Version {#suppress-submissions}

During _Case_ processing, if a _Case_ is considered invalid, then you can exclude that version of the _Case_ from ICSR _Submissions_ and PADER aggregate reports.

In the _Details_ section of the _Case_, select the **Suppress Submission** checkbox.



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      <p><strong>Note</strong>: Your Admin may need to <a href="/en/gr/01428/">configure the Suppress Submissions feature</a>, including adding the <em>Suppress Submission</em> field to the <em>Case</em> layouts.</p>
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### What Happens When You Suppress Submissions

When _Suppress Submission_ is selected on a _Case_, the result is as follows:

* **Submissions and Distributions**: When the <a href="/en/gr/01264/#transmission-generation">_Evaluate Regulatory Obligations_</a> action runs, Vault ignores _Submissions_ for the _Case_, and generates only _Distributions_.
* **Aggregate Reporting**: PADER aggregate report tabulations omit those _Case_ versions within the reporting period.

## 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:

* For the FDA, see the "C.1.11.1 Report Nullification / Amendment" section of the <a class="external-link " href="https://www.fda.gov/media/81904/download" target="_blank" rel="noopener">FDA E2B(R3) Implementation Guide<i class="fa fa-external-link" aria-hidden="true"></i></a>.
* For the EMA, see the guidance on <a class="external-link " href="https://www.ema.europa.eu/en/documents/presentation/presentation-eudravigilance-reporting-process-users-create-send-individual-case-safety-reports-icsrs_en.pdf" target="_blank" rel="noopener">Creating and Sending ICSRs<i class="fa fa-external-link" aria-hidden="true"></i></a>.

### Nullify a Submission {#nullify-case}

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

1. On the _Case_, go to the _Transmissions_ section.
2. Open the _Transmission_ you wish to amend or nullify.
3. Create a new _Transmission_ through one of the following methods:
    * In the **All Actions** menu, select **Copy Record**. Vault copies the record to create a new _Transmission_.
    * Select **Create** and manually enter the details to <a href="/en/gr/1022564/">create a new _Transmission_</a>.
4. Ensure that the **File**, **Reason**, and **E2B Message ID** fields are blank. If these fields have been copied over, clear the data and contact your Admin 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 the reason for the nullification.
    * **E2B Message ID**: Enter a new message ID to use in the E2B message header.
6. In the **All Actions** menu, select **Generate Transmission Document(s)**.
7. Send the _Transmission_ to the destination <a href="/en/gr/01266/">gateway</a>.

### Omit Nullified Cases from PADER Aggregate Reports {#omit-nullified-from-aggregates}

You can omit _Cases_ considered nullified from <a href="/en/gr/01281/">PADER aggregate reports</a>. Other <a href="/en/gr/01129/#supported-aggregate-reports">supported aggregate reports</a> do not consider _Transmissions_ during report tabulation. To omit a nullified _Case_ during PADER generation:

1. [Nullify all _Submissions_][2] associated with the _Case_. Each nullified _Transmission_ must meet the following requirements:
    * The _Reason_ field value must be _Nullification_.
    * The _Submission_ must be in the _ACK Accepted_ or _Completed_ state.
2. Move the _Case_ to the _Nullified_ state. Once a _Case_ enters the _Nullified_ state, it is locked to prevent further processing.

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      <p><strong>Note</strong>: Your Admin may have configured a user action or workflow to change the <em>Case</em> state to <em>Nullified</em>. Consult your organization’s standard operating procedures for guidance.</p>
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**Result**

When the _Case_ moves to the _Nullified_ state, Vault selects the _Suppress Submission_ field on the current version of the _Case_. On new PADER aggregate reports, the current version of the _Case_ and previous versions within the aggregate reporting period are excluded.

### Amend a Submission {#amend-case}

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

1. On the _Case_, go to the _Transmissions_ section.
2. Open the _Transmission_ you wish to amend or nullify.
3. In the **All Actions** menu, select **Copy Record**. Vault copies the record to create a new _Transmission_.
4. Ensure that the **File**, **Reason**, and **E2B Message ID** fields are blank. If these fields have been copied over, clear the data and contact your Admin 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. In the **All Actions** menu, select **Generate Transmission Document(s)**.
7. Send the _Transmission_ to the destination <a href="/en/gr/01266/">gateway</a>.

## Void a Case {#void-case}

You can use the _Void Case_ action from the **All Actions** menu to logically delete a _Case_, with the option to nullify all previous _Transmissions_ at the _Case_ level. This action is available only for the latest _Case_ version. If there are multiple active _Case_ versions, _Void Case_ is not available.

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      <p><strong>Note</strong>: “Void” and “logically delete” are interchangeable terms. Vault Safety uses the term “void”, although “logically delete” is more widely used in the industry. Your Admin can re-label the action and state names if preferred.</p>
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When you nullify previous _Transmissions_, you enter the nullification reason text that will be copied to all system-generated _Transmission_ records relevant to the _Case_. Vault generates _Transmission_ records for all previously submitted destinations.

### Prerequisites

Your Admin must <a href="/en/gr/01336/">enable _Case_ nullification</a>.

### What Happens When You Void Cases

When you initiate the _Void Case_ action, Vault cancels any in-progress _Case_ workflows. State changes (for example, to _Voiding_ or _Nullifying_) apply only to the latest _Case_ version.

If the _Case_ on which the _Void Case_ action is triggered is in any of the following lifecycle states, the lifecycle state is updated to _Withdrawn_ (otherwise, the state does not change):

* _Active_
* _Inactive_
* _Ready_
* _Pending_
* _Validation Error_
* _Ready for Submission_
* _Error_
* _MDN Failure_
* _E2B ACK Warning_
* _E2B ACK Rejected_

For completed _Transmissions_ from the current and previous versions of the _Case_, Vault generates new _Transmission_ records for all destinations from unique _Transmission Profiles_. _Transmission Profiles_, _Destination Organizations,_ and _Origin Organizations_ must be active for Vault to generate _Transmission_ records.

The _Transmission_ record settings are as follows:

<table>
    <thead>
        <tr>
            <th>Transmission Field</th>
            <th>Setting</th>
        </tr>
    </thead>
        <tbody>
        <tr>
            <td><em>Case</em></td>
            <td>The current version of the <em>Case</em></td>
        </tr>
        <tr>
            <td><em>Reason</em></td>
            <td>Select <strong>Nullification</strong> if the <em>Nullify Transmissions</em> field on the <em>Logically Delete Case</em> dialog is <em>Yes</em>.</td>
        </tr>
        <tr>
            <td><em>Transmission Reason Text</em></td>
            <td>Includes the nullification reason entered in the <em>Reason (Text)</em> field during <em>Case</em> voiding.</td>
        </tr>
        <tr>
            <td><em>Due Date</em></td>
            <td>The <em>Transmission</em> due date is calculated by adding the <em>New Info Date</em> to the <em>Due in Days</em> value.</td>
        </tr>
        <tr>
            <td><em>Due in Days</em></td>
            <td>This value is copied from the previous <em>Transmission</em> for the destination.</td>
        </tr>
        <tr>
            <td><em>Transmission Date</em></td>
            <td>This is set to the current date.</td>
        </tr>
        <tr>
            <td><em>Local Expedited Criteria</em></td>
            <td>This value is copied from the previous <em>Transmission</em> for the destination.</td>
        </tr>
        <tr>
            <td><em>Exceptions to Patient Content Protection</em></td>
            <td>This value is copied from the previous <em>Transmission</em> for the destination.</td>
        </tr>
        <tr>
            <td><em>Study Content Protection</em></td>
            <td>This value is copied from the previous <em>Transmission</em> for the destination.</td>
        </tr>
        <tr>
            <td><em>Transmission Profile</em></td>
            <td>This value is copied from the previous <em>Transmission</em> for the destination.</td>
        </tr>
        <tr>
            <td><em>FDA Report Type</em></td>
            <td>If the <em>Transmission</em> destination is FDA, this value is copied from the previous <em>Transmission</em>.</td>
        </tr>
        <tr>
            <td><em>Reportable Product</em></td>
            <td>If the <em>Transmission</em> destination is FDA and the <em>Case</em> is non-study type, this value is copied from the previous <em>Transmission</em>.</td>
        </tr>
        <tr>
            <td><em>Reportable Product Registration</em></td>
            <td>If the <em>Transmission</em> destination is FDA and the <em>Case</em> is non-study type, this value is copied from the previous <em>Transmission</em>.</td>
        </tr>
        <tr>
            <td><em>Reportable Study</em></td>
            <td>If the <em>Transmission</em> destination is FDA and the <em>Case</em> is study type, this value is copied from the previous <em>Transmission</em>.</td>
        </tr>
        <tr>
            <td><em>Reportable Study Registration</em></td>
            <td>If the <em>Transmission</em> destination is FDA and the <em>Case</em> is study type, this value is copied from the previous <em>Transmission</em>.</td>
        </tr>
        <tr>
            <td><em>E2B Message ID</em></td>
            <td>If the <em>Transmission</em> format is E2B, Vault generates a new value.</td>
        </tr>
    </tbody>
</table>

Vault populates _Transmission Profile_-related fields on the _Transmission Profile_, and leaves all other fields blank. Any custom field that does not have the _Do not copy this field in Copy Record_ checkbox selected is copied to the new _Transmission_ record. To prevent this, your Admin must select the <a href="/en/gr/15057/#how-to-add-object-fields">_Do not copy this field in Copy Records_</a> checkbox on the custom field.


### 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. In the **All Actions** menu, select **Void Case**. The _Case_ moves to the _Voiding_ state and must be reviewed before transitioning to the _Voided_ state.
3. Beside _Voiding of Case_, select **Complete**. The _Review Voiding of Case_ window is displayed.
4. Complete all of the fields to finalize the review.
5. Select **Complete**.

**Result**

The _Case_ is successfully voided and moved to the _Voided_ state.

### Void a Case and Nullify all Previous Transmissions {#void-case-nullify-all-transmissions}

To void a _Case_ with previous transmissions:

1. Navigate to the duplicate _Case_ you want to void.
2. In the **All Actions** menu, select **Void Case**. The _Nullification details_ window appears.
3. In the **Nullify Transmissions** field, select **Yes**.
4. In the **Reason (Text)** field, enter the **nullification reason**.
5. Select **Continue**.

**Result**

The _Case_ enters the _Nullifying_ state. Vault auto-generates _Transmission_ records, including the nullification reason, for 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_.

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      <p><strong>Note</strong>: If you choose not to nullify the previous <em>Transmissions</em> (by selecting <strong>No</strong> from the <strong>Nullify Transmissions</strong> field), Vault will still exclude the previous <em>Transmissions</em> from aggregate reports.</p>
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### Void a Case and Submit One Last Time

1. Navigate to the duplicate _Case_ you want to void.
2. In the **All Actions** menu, select **Void Case**. The _Case_ moves to the _Voiding_ state and must be reviewed before transitioning to the _Voided_ state.
3. Beside **Voiding of Case**, select **Complete**. The **Nullification details** window appears.
4. In the **Nullify Transmissions** field, select **No (Submit one last time)**.
5. In the **Reason (Text)** field, enter the nullification reason.
6. Select **Continue**.

**Result**

The _Case_ enters the _Voiding_ state. Vault cancels any existing workflows and creates follow-up _Transmission_ records, including the nullification reason, for all previously submitted destinations. When the _Transmissions_ are complete, the _Case_ moves to the _Voided_ state.

### Audit Log for Case Voiding

Any _Void Case_ actions and workflow cancellations are captured in the audit trail during _Case_ voiding.

If your Admin has configured the _Case Voiding_ workflow to require a "Workflow cancellation comment", when an in-progress workflow is cancelled, the audit trail logs this. The cancellation is logged as performed by "System", with the system-generated comment, "Cancelling in-progress workflow to void the case".

See <a href="/en/gr/01152/">Audit Case History</a> for more information on the _Case_ audit trail.

[1]: #suppress-submissions
[2]: #nullify-case
[3]: #omit-nullified-from-aggregates
[4]: #amend-case
[5]: #void-case
[6]: #void-case-nullify-all-transmissions