Vault supports creating Early Notification reports if you have an agreement with an agency or partner organization to share Case details early in the Case lifecycle. 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 |
|---|---|
| Case | Vault populates a link to the Case. |
| 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 | Select the organization that your Admin has set up as Vault Customer for your Vault. |
| Destination | Select the destination to direct the ICSR. |
| 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. |
| File | Vault populates a link to the generated transmission document. |
| Transmission Document Status | During document generation, Vault populates Generating. Upon completion, Vault clears this field. |
| Due Date | If the Early Notification record is created by a passing reporting rule, Vault populates this field. |
| Reason | The reason for submitting this ICSR to the agency. Vault may populate this field based on a reporting rule or Case-level value. You can select from the following options:
If configured by your Admin, if a Case does not have a previous Transmission to a destination, including for follow-ups to imported Cases, Vault populates Note: If a Case includes a Transmission Reason, selecting a Transmission Reason on the Transmission 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. |
| Transmission Sent Date |
The date and time the Early Notification was sent to the destination. For Early Notifications sent by gateway, enter the date and time that Vault received the MDN signal. For manual Early Notifications, enter the confirmed date and time the Early Notification was sent to the destination. |
| Transmission Completed Date |
The confirmed date and time the Early Notification was completed. For Early Notifications sent by gateway, enter the date and time that Vault received the final ACK signal. For manual Early Notifications, enter the confirmed date and time the Early Notification was completed. |
| 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 < |
| 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. |
| Approval Due in Days |
When the Safety Rules Engine creates a non-OLT Early Notification, Vault sets this field of the Early Notification to the value in the Approval Due in Days rule parameter if one exists, otherwise Vault leaves this field blank. For an OLT Early Notification, Vault sets this field to the same Approval Due in Days value as the Early Notification being copied. If required for manually created Early Notifications, enter the whole number of days by which the Case must be approved. Otherwise this field is optional for manually created Early Notifications. |
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: