Track a Manual Transmission

If you cannot submit an ICSR electronically using an AS2 gateway, for example if you must submit an FDA 3500A report for a study, you can record and track manual ICSR Transmissions outside of Safety. Vault includes a Manual Transmission workflow to track past submissions and status of ongoing submissions. This page describes the default Manual Transmission workflow. However, your organization may have a custom configuration.

Prerequisites

• The Transmission must be created, either as a Submission or Distribution.
• To populate the sender contact details on the generated ICSR, the Sender User should have full contact and organization details on their Vault Safety account.

Manual Transmission Workflow

Stage	Lifecycle State	Description
Pending	Pending	Pending is the initial stage and state of the Submission record after you generate the submission document(s). The system assigns a task to review and approve the submission.
Pending	Ready to Submit	After the Submission record and ICSR document(s) are reviewed and approved, the Submission record enters this state to indicate that it is ready for submission. The system assigns a task to manually submit the report.
Accepted	Complete	After the task to manually submit the case is marked as complete, the Submission record enters the Accepted stage and the Complete state to indicate submission is done.

Generate the ICSR Document for Submission

Generate the submission document starts the FDA Manual Submission workflow:

1. Navigate to the Submission record.
2. Check that the report type in the Transmission Document Type field is the report that you want to generate.
3. To change the report type, select Edit, and then choose a different report in the Transmission Document Type field.
4. Expand the All Actions menu, and then select Generate Transmission Document(s).

When the action completes, Vault generates the case report document and adds a link to the document to the File field (If you do not see the file, refresh the page). The Submission moves to the Pending stage. Vault assigns a Review Submission task to the Sender User.

Review the Submission

1. Navigate to the Submission record.
2. Review the Details section and ensure the details are correct.
3. To review the submission document, in the File field, select the document link. The document opens in the Library.
4. Once you have reviewed the file, return to the Submission record.
5. In the Review Submission task banner, select Complete. The Review Submission window appears.
6. Select Complete.

When the action completes, Vault assigns a Submit to Regulatory Authority task.

Complete the Submission

Coordinate the submission outside of Vault Safety and then mark the submission as complete to finalize the submission.

Export the Submission Document

To export the submission document:

1. Navigate to the Submission record.
2. In the File field, select the document link. The document opens in the Library.
3. Expand the Document menu, and then select Source Document.
   • The Document menu displays differently depending on the type of report ( for CIOMS I and FDA 3500A or for E2B).

Mark the Submission as Complete

To move the Submission to the Complete state:

1. Accept the Submit to Regulatory Authority task.
2. Beside the Submit to Regulatory Authority task, select Complete. The Submit to Regulatory Authority window appears.
3. For Destination Case ID, enter the destination identification number for the submission.
4. For Transmission Date, enter the date and time when the report was submitted.
5. Select Complete.