Create a Submission

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

Creating Submissions

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

The Submission workflow depends on your Admin’s 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

Your Admin must have configured the Transmission Profile and AS2 Connection for the destination agency.
To automatically generate Submissions, your Admin must configure the appropriate reporting rules.
You must have permissions to manage Transmission object records. Typically, these permissions are reserved for Distribution Manager users.
To submit Clinical Trial Cases with the Spontaneous Report Type in EMA E2B(R3) reports, your Admin must enable EMA Clinical Trial Submissions: Non-Study Suspect Products.

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.

The Submissions that Vault Safety generates depends on individual Case criteria and the active Submission Rules in your Vault.

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 Submissions based on configured reporting rules, you can manually create Submissions for ad-hoc reporting, such as amendments or nullifications.

On the Case that you want to submit, expand the Transmissions section, and then select Create.
In the Create Transmission window, select Submission, and then select Continue.
Complete the fields on the Create Submission page, as required. Submission Fields provides more information.
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
Transmission Profile	Select the Transmission Profile configured for submitting ICSRs to the destination agency. Depending on your Admin's configuration, selecting the Transmission Profile automatically populates the following fields: Origin Destination Outbound Format Additional Output Formats Sender User Message Subject (including tokens) Message Body (including tokens) Cover Letter Template
Origin	Select the organization set up as Vault Customer (`vault_customer__v`) for your Vault.
Destination	Select the destination agency to which the report will be sent.
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 your Admin has configured the Transmission Profile to populate this field with a default Sender User, this field is automatically populated on the Transmission. If this field is left blank on the Transmission Profile, it is populated with the person 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 or the Case-level value. You can select from 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. Note: If a value has been entered in the Transmission Reason field of the Case, that value is overridden by selecting a value in this field.
Reason Text	For nullification and amendments only, enter more information about the submission reason. This field may be automatically populated based on the Case-level value. Note: If a value has been entered in the Transmission Reason Text field of the Case, that value is overridden by selecting a value in this field.
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 layouts by default, but can be added to Transmission layouts by your Admin.
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 layouts by default, but can be added to Transmission layouts by your Admin.
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 Submission is manually created or 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.
Report Type Override	When reporting to the EMA, you can override the Report Type. This is useful, for example, when a Clinical Trial Case involves adverse events related solely to non-investigational medicinal products available in the EU. Select a Report Type from the picklist. When generating EMA E2B(R3) reports, the C.1.3 Type of Report data element is populated with the corresponding code. This overrides the value in the Report Type field on the Case. Additionally, if Report Type Override is set to Spontaneous, the C.5 Study Identification block is not generated. For more information, see E2B Generation Data Mapping: EMA E2B(R3).
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. Your Admin 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. Your Admin 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.
Registered As	Select the product type classification for generating the ICSR document. Depending on your Admin's configuration, this field may be called Transmission Product Type. 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 layouts by default, but can be added by your Admin.
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 layouts by default, but can be added by your Admin.
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 layouts by default, but can be added by your Admin.
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 layouts by default, but can be added by your Admin.
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: