Create a Submission

Create a Submission to report a case to a regulatory agency.

Sections in This Article

Creating Submissions

Submissions can be created automatically during Case workflows, or manually.

The Submission workflow depends on your vault configuration. By default, after a Submission is created, Vault Safety assigns a task to users in the Distribution Manager role to review and approve the Transmission and Individual Case Safety Report (ICSR) document before transmitting the Submission.

Prerequisites

  • An administrator must have already configured the Transmission Profile and Gateway Settings for the destination agency.
  • To automatically generate Submissions, an administrator must configure the appropriate reporting rules.
  • You must have permissions to manage Transmission object records. Typically, these permissions are reserved for Distribution Manager users.

Automatic Creation

Vault Safety automatically creates Submission records when the Evaluate Reporting Obligations action runs on the Case. By default, when a Case enters the Approved state, the system creates any necessary Submissions.

Note When Submissions are generated for a Domestic Case, the system automatically links any Localized Cases for countries within the reporting jurisdiction.

Regenerate Automatically Created Submissions

To prevent duplicate Submission records, if Case details are changed, Vault Safety only regenerates a Submission record if one does not already exist for the same Transmission Profile.

To regenerate a Submission record to replace one that already exists, mark the Submission record inactive, and then trigger the Evaluate Reporting Obligations action, for example, by moving the Case back to the Approved state.

Manual Creation

While the system automatically creates Submission, you can manually create Submissions for ad-hoc reporting, such as amendments or nullifications.

Create a Submission

  1. On the case that you want to submit, expand the Transmissions section, and then select Create.
  2. In the Create Transmission window, select Submission, and then select Continue.
  3. Complete the fields on the Create Submission page, as required.
    Submission Fields provides more information.
  4. Select Save.

Result

The system creates the Submission and creates a Review Submission task for users in the Distribution Manager role.

Submission Fields

Field Description
Origin Select the organization set up as Vault Customer (vault_customer__v) for your vault.
If you select the Transmission Profile, this field is automatically populated.
Destination Select the destination agency to which the report will be sent.
If you select the Transmission Profile, this field is automatically populated.
Transmission Profile Select the Transmission Profile configured for submitting ICSRs to the destination agency.
Transmission Document Type Select ICSR document format to generate for the transmission.
For Gateway Transmissions, select an E2B format. For more information on which report formats to generate for different regulatory agencies, see the report formats detailed on Standard Agency ICSR Submissions.
Additional Transmission Document Type(s) If required, select additional ICSR document formats to generate for the transmission.
Sender (User) If an administrator has configured the Transmission Profile to populate this field with a default Sender User, this field is automatically populated in the system generated transmission.

If this field is left blank on the Transmission Profile, it will be populated with the user assigned the Head of Safety sharing role.

Transmission Reason The reason for submitting this ICSR to the agency. This field may be automatically populated based on the reporting rule.
You can select one of the following options:
  • Initial: The first submission of the case.
  • Amendment: An amendment to a prior submission.
  • Follow-Up: A follow-up case.
  • Nullification: Report a case as nullified.
Reason Text For nullification and amendments only, enter more information about the submission reason.
Due Date The Submission due date is automatically generated based on the case attributes and reporting rule for the jurisdiction.
Local Expedited Criteria

Whether the Case requires expedited reporting, according to agency-specific criteria. For example, the FDA's local expedited criteria for post-market cases is serious and unexpected.

The system automatically sets this field after matching the Case to the appropriate reporting rule. You can manually edit this field to override the system-set local expedited value.

This field does not appear on page layouts by default, but can be added to Transmission page layouts by an administrator.

Downgraded

Marks Cases that match a downgrade scenario. The system automatically sets this field after matching the Case to the appropriate reporting rule.

A downgraded case is a Follow-Up Case that does not fulfill local expedited criteria (Local Expedited Criteria=No), but has a preceding Case version with a Transmission that meets the following conditions:

  • Expedited (Local Expedited Criteria=Yes)
  • Not downgraded (Downgraded=No)

This field does not appear on page layouts by default, but can be added to Transmission page layouts by an administrator.

Organization The system automatically populates this field when you create a Transmission from a Case.
E2B Message ID Message ID to use in the E2B message header. The system automatically populates this field with a message ID when the Submit to Gateway action is triggered.
Destination Case ID The system automatically populates this field upon receipt of the final acknowledgment (ACK) when you export E2B Submissions.
Transmission Date The date of transmission. The system automatically populates this field with time and date of submission when the Submit to Gateway action is triggered.
This field is required for EMA submissions.
FDA Report Type

For manual submissions using the FDA 3500A form, you can optionally use this field to specify the report type. The value in this field populates the appropriate checkbox in box G.7 Type of Report.

If you don't specify this field, the system automatically calculates G.7 Type of Report.

Auto-Submit Select Yes to enable automatic Transmissions directly from the Case.

Leave this field blank to require users to trigger the Transmission manually from the Submission or Distribution record. An administrator may need to configure this field to appear in your vault.

Auto-Submissions provides more information.

Follow-up Number

The system automatically populates this field. The Follow-Up Number is based on the number of previously completed Submissions to the same reporting destination for the Case, including previous Case versions. Prior Submissions must be in the ACK Accepted or Completed state to be counted.

You can manually override the value, however, this field is hidden by default. An administrator can add this field to the layout, or you can add the field to the grid view on the Submissions tab.

Note the following considerations about the Submission Follow-up Number:

  • The system generates an initial Submission with a Follow-up Number when the initial Case is not a SUSAR or SAE but has a completed Submission, and the Follow-Up Case is upgraded to a SUSAR or SAE.
  • The system generates a follow-up Submission without a Follow-up Number when the initial SUSAR or SAE Case does not have a completed Submission. For example, E2B imported Cases. As a workaround, you can manually change the Reason to Follow-up and set the Follow-up Number to 1.
Transmission Messages Contains any acknowledgments being sent in the submission process. The initial “Creation Message” captures the outcome of the rule engine.
Attachments Contains a .csv attachment file which displays schema validation errors.
Transmission Product Type

Select the product type classification for generating the ICSR document.

For Combination Product reports, the value in this field determines whether Device-type Product Constituents are exported in the E2B file. If this field is left blank or set to Combination Product, the device constituents are exported. Otherwise, only non-device Product Constituents are exported to the E2B file.

See Exclude Device Constituents from E2B Exports for more information.

Safety Report Version

The version of the safety report. This field populates the <safetyreportversion> tag in E2B (R2) exports. By default, this field is populated with the Version from the Case. An admin can edit the default value in the field settings. This field has a two-character limit.

This field does not appear on page layouts by default, but can be added by an administrator.

Message Type (HC)

For submissions to Health Canada, you can use this field to select the Message Type (M.1.1) to populate when generating a transmission document in the "HC E2B R2" format.

This picklist contains the following standard options:

  • ichicsr: Message type for post-market submissions to the Marketed Health Products Directorate (MHPD)
  • cticsr: Message type for clinical trial submissions the Therapeutic Products Directorate (TPD)
  • camricsr: Message type for the Canada’s Access to Medicines Regime (CAMR)
  • sapicsr: Message type for the Special Access Programme (SAP)

This field set to the following default values when using standard Health Canada Transmission Profile:

  • For the HC MHPD Transmission Profile, this field is set to ichicsr.
  • For the HC TPD Transmission Profile, this field is set to cticsr.

This field does not appear on page layouts by default, but can be added by an administrator.

Patient Content Protection

(Optional) To mask patient data in the generated safety report, select a masking option.

Mask Personal Identifiable Information (PII) describes the data masked by each option.

This field does not appear on page layouts by default, but can be added by an administrator.

Exceptions to Patient Content Protection

(Optional) To leave certain information unmasked when using Patient Content Protection, select one or more fields to unmask.

Exceptions to Patient Content Protection describes the data unmasked by this option.

This field does not appear on page layouts by default, but can be added by an administrator.

Validation Status

The calculated Validation Result for the Submission.

The following list describes the Validation Status field values:

  • Pass: No validation rule failures were found.
  • Warning: At least one validation rule has failed to pass with a Warning status.
  • Fail: At least one validation rule has failed to pass with a Fail status.
  • Hard Fail: At least one validation rule has failed to pass with a Hard Fail status.

Note You cannot trigger the Submit to Gateway action if the Validation Status is Hard Fail. The system will not trigger auto-submission if the Validation Status is Fail or Hard Fail.

To learn more, see Case and Submission Validation.

Next Steps to Complete the Transmission

Once you have created the Submission record, you can proceed with handling the transmission using one of the following methods, depending on the type of Transmission Profile being used:


Submissions and Distributions Overview
Create a Distribution
Feedback?