Create an Early Notification Report

Create an Early Notification report if you have an agreement with an agency or partner organization to share Case details early in the Case lifecycle.

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.

Creating Early Notifications

Early Notifications can be created automatically during Case workflows, or manually.

For non-Email Transmission Profile type Early Notifications, the Early Notification workflow depends on your Admin’s configuration. By default, after an Early Notification is created, Vault assigns a task to users in the Distribution Manager application role to review and approve the Transmission and Individual Case Safety Report (ICSR) document before transmitting the Early Notification.

Prerequisites

The following prerequisites apply to Early Notifications:

Your Admin must have already configured the Transmission Profile for the agency or partner.
For Vault to generate Early Notifications, your Admin must configure reporting rules.
You must have permissions to manage Transmissions. Typically, these permissions are reserved for Distribution Manager users.

Automatic Creation

The Early Notifications that Vault generates depends on individual Case criteria and the active Early Notification rules in your Vault.

Regenerate Automatically Created Early Notifications

To prevent duplicate Early Notifications, if Case details are changed, Vault regenerates an Early Notification only if one (1) does not already exist for the same Transmission Profile.

To regenerate an Early Notification to replace one (1) that already exists, move the Early Notification to inactive, and then run the Evaluate Early Reporting Obligations action, for example, by moving the Case back to the appropriate state.

Automatic Creation of Masked Early Notifications

For Cases linked to a Study or Product Family with a reporting rule with content protection, when the Case enters the appropriate state, Vault generates Early Notifications with data masking.

The name of the generated Early Notification file includes a prefix that identifies the masking option:

Mask PII: Early Notification files generated with Patient Content Protection set to Mask PII.
Mask E2B (Includes PII): Early Notification files generated with Patient Content Protection set to Mask E2B (Includes PII).
Blinded: Early Notification files generated with Study Content Protection set to Mask Unblinded Content.

Manual Creation

While Vault automatically creates Early Notifications based on configured reporting rules, you can manually create Early Notifications for ad-hoc reporting.

Create an Early Notification

Complete the following steps to manually create an Early Notification:

On the Case for which you want to send an early notification, expand the Submissions and Distributions section, and then select Create.
In the Create Transmission window, select Early Notification, and then select Continue.
Complete the fields on the Create Early Notification page, as required.
Select Save.

Early Notification Fields

The following fields may be available:

Field	Description
Origin	Select the organization that your Admin has set up as Vault Customer for your Vault.
Destination	Select the destination to direct the ICSR.
Transmission Profile	Select the Transmission Profile configured for trading ICSRs with the partner. 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
Transmission Document Type	Select the ICSR document format to generate for the transmission. For Gateway Transmissions, select an E2B format. Generate a Regulatory Report provides more information on the supported formats.
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.
Due Date	If the Early Notification record is created by a passing reporting rule, Vault populates this field.
Reason	Select the reason for sending this ICSR to the destination gateway. 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: Submission of a case to report it as nullified. Note: If the Transmission Reason field of the Case contains a value, selecting a value here overrides the Case value.
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 the Transmission Reason Text field of the Case contains a value, selecting a value here overrides the Case value.
Follow-up Number	For follow-ups only, enter the follow-up number.
Organization	Vault populates this field when you create a Transmission from a Case.
E2B Message ID	Message ID to use in the E2B message header. Vault populates this field when the Transmission is manually created or the Submit to Gateway action runs.
Destination Case ID	Vault automatically populates this field upon receipt of the final acknowledgment (ACK) when you export E2B Submissions.
Transmission Date	The date of transmission. Vault populates this field with the time and date of Transmission when the Submit to Gateway action runs.
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.
Safety Report Version	The version of the safety report. This field populates the <`safetyreportversion`> tag in E2B(R2) exports. The default value is taken from the Version field on the Case. This field has a two-character limit.
Patient Content Protection	To mask patient data in distributions, select a masking option. For more information, see Generate Masked Safety Reports.
Study Content Protection	To protect unblinded study data in Transmissions, select Mask Unblinded Content. For more information, see Generate Masked Safety Reports.
Exceptions to Patient Content Protection	To leave certain information unmasked when using Patient Content Protection, select one (1) or more fields to unmask. For more information, see Generate Masked Safety Reports.

Destination-Specific Document Inclusions

When you create an Early Notification, based on your Admin’s configuration of the applicable Transmission Profile, Vault attaches documents and literature articles specific to the reporting destination. You can view the list of attachments in the Destination Specific Document Inclusions section of the Early Notification.

Next Steps to Complete the Transmission

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