Learn how to suppress Submissions of a Case, and amend or nullify previous E2B Transmissions.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
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. 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 organization’s standard operating procedures for more information.
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Void: When a Case is logically deleted, 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).
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Follow-Up: Additional information about a Case that was received after the initial submission.
Note: You cannot create a follow-up Case from a Case that has been nullified or voided.
See Case Processing Overview for more information on Case states.
Suppress Submissions of a Case Version
During Case processing, if a Case is considered invalid, then you can exclude that version of the Case from ICSR Submissions and periodic reports.
In the Details section of the Case, select the Suppress Submission checkbox.
Note: Your Admin may need to configure the Suppress Submissions feature, including adding the Suppress Submission field to the Case layouts.
What Happens When You Suppress Submissions
When Suppress Submission is selected on a Case, the result is as follows:
- Submissions and Distributions: When the Evaluate Regulatory Obligations action runs, Vault ignores Submissions for the Case, and generates only Distributions.
- Aggregate Reporting: 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 FDA E2B(R3) Implementation Guide.
- For the EMA, see the guidance on Creating and Sending ICSRs.
Nullify a Submission
To nullify a previously submitted report, perform the following steps:
- On the Case, go to the Transmissions section.
- Open the Transmission you wish to amend or nullify.
- 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 create a new Submission or Distribution.
- 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.
- 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.
- In the All Actions menu, select Generate Transmission Document(s).
- 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:
- Nullify all Submissions associated with the Case. Each nullification Transmission record must meet the following requirements:
- The Reason field must be Nullification.
- The Submission record must be in the ACK Accepted or Completed lifecycle state.
- Move the Case to the Nullified lifecycle state. Once a Case enters the Nullified state, it is locked to prevent further processing.
Note: Your Admin 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
When the Case lifecycle moves to the Nullified state, Vault selects the Suppress Submission field on the current version of the Case. On new 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:
- On the Case, go to the Transmissions section.
- Open the Transmission you wish to amend or nullify.
- In the All Actions menu, select Copy Record. Vault copies the record to create a new Transmission.
- 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.
- 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.
- In the All Actions menu, select Generate Transmission Document(s).
- 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, 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.
Note: “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.
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 enable Case nullification.
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:
| Transmission Field | Setting |
|---|---|
| Case | The current version of the Case |
| Transmission Reason | Set to Nullification if the Nullify Transmissions field on the Logically Delete Case dialog is Yes. |
| Transmission Reason Text | Includes the nullification reason entered in the Reason (Text) field during Case voiding. |
| Due Date | The Transmission due date is calculated by adding the New Info Date to the Due in Days value. |
| Due in Days | This value is copied from the previous Transmission for the destination. |
| Transmission Date | This is set to the current date. |
| Local Expedited Criteria | This value is copied from the previous Transmission for the destination. |
| Exceptions to Patient Content Protection | This value is copied from the previous Transmission for the destination. |
| Study Content Protection | This value is copied from the previous Transmission for the destination. |
| Transmission Profile | This value is copied from the previous Transmission for the destination. |
| FDA Report Type | If the Transmission destination is FDA, this value is copied from the previous Transmission. |
| Reportable Product | If the Transmission destination is FDA and the Case is non-study type, this value is copied from the previous Transmission. |
| Reportable Product Registration | If the Transmission destination is FDA and the Case is non-study type, this value is copied from the previous Transmission. |
| Reportable Study | If the Transmission destination is FDA and the Case is study type, this value is copied from the previous Transmission. |
| Reportable Study Registration | If the Transmission destination is FDA and the Case is study type, this value is copied from the previous Transmission. |
| E2B Message ID | If the Transmission format is E2B, Vault generates a new value. |
Transmission Profile-related fields are populated based on the Transmission Profile. All other system fields are left 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 Do not copy this field in Copy Records checkbox on the custom field.
Void a Case with No Previous Transmissions
To void a Case with no previous transmissions:
- Navigate to the Case you want to void.
- 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.
- Beside Voiding of Case, select Complete. The Review Voiding of Case window is displayed.
- Complete all of the fields to finalize the review.
- Select Complete.
Result
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:
- Navigate to the duplicate Case you want to void.
- In the All Actions menu, select Void Case. The Nullification details window appears.
- In the Nullify Transmissions field, select Yes.
- In the Reason (Text) field, enter the nullification reason.
- 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.
Note: If you choose not to nullify the previous Transmissions (by selecting No from the Nullify Transmissions field), Vault will still exclude the previous Transmissions from aggregate reports.
Void a Case and Submit One Last Time
- Navigate to the duplicate Case you want to void.
- 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.
- Beside Voiding of Case, select Complete. The Nullification details window appears.
- In the Nullify Transmissions field, select No (Submit one last time).
- In the Reason (Text) field, enter the nullification reason.
- 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 Audit Case History for more information on the Case audit trail.